HK1241782B - Systems and methods for providing non-invasive neurorehabilitation of a patient - Google Patents

Description

Systems and methods for providing non-invasive neurorehabilitation to patients

Cross-references to related patent applications

This application claims priority to and the benefit of U.S. patent application serial number 14/558,768, filed on December 3, 2014, U.S. patent application serial number 14,558,775, filed on December 3, 2014, U.S. patent application serial number 14,558,784, filed on December 3, 2014, and U.S. patent application serial number 14/727,100, filed on June 1, 2015, the entireties of which are incorporated herein by reference.

Technical Field

Generally speaking, the present invention relates to devices and methods for non-invasive (non-invasive) neural stimulation of a subject's brain. More specifically, the present invention relates to devices and methods for non-invasive neural stimulation of a subject's brain to effect treatment of various diseases.

Background Art

Traumatic brain injury (TBI) is a leading cause of disability worldwide. Approximately two million people in the United States suffer TBI each year, many of whom experience long-term symptoms. These symptoms include impaired attention, judgment, processing speed, and deficits in abstract reasoning, planning, problem-solving, and multitasking.

A stroke is a loss of brain function caused by a disruption in blood flow to the brain. Approximately 800,000 people in the United States suffer a stroke each year. Stroke is a leading cause of long-term disability in the United States, with nearly half of older stroke survivors experiencing moderate to severe disability. Long-term effects can include seizures, incontinence, visual impairment or loss, difficulty swallowing, pain, fatigue, cognitive impairment, aphasia, short-term and/or long-term memory loss, and depression.

Multiple sclerosis (MS) is a disease that damages nerve cells in the brain and spinal cord. Approximately 2.5 million people worldwide suffer from MS. Symptoms can vary greatly depending on the specific location of damage in the brain or spinal cord. Symptoms include decreased perception, difficulty with coordination and balance, speech problems, difficulty swallowing, nystagmus, bladder and bowel problems, cognitive impairment, and severe depression.

Alzheimer's disease (AD) is a neurodegenerative disease affecting over 25 million people worldwide. Symptoms include confusion, irritability, aggression, mood swings, difficulty speaking, and both long-term and short-term memory loss. In developed countries, AD is one of the most costly diseases to society.

Parkinson's disease (PD) is a degenerative disorder of the central nervous system that affects more than 7 million people worldwide. Symptoms of PD include tremors, bradykinesia, rigidity, postural instability, cognitive impairment, and behavioral and mood changes.

One approach to treating the long-term symptoms associated with traumatic brain injury, stroke, multiple sclerosis, Alzheimer's disease, and Parkinson's disease is neurorehabilitation. Neurorehabilitation involves processes designed to help patients recover from damage to their nervous system. Traditionally, neurorehabilitation involves physical therapy (e.g., balance retraining), occupational therapy (e.g., safety training, memory and cognitive retraining), psychotherapy, speech and language therapy, and therapies focused on daily functioning and reintegration into the community.

Another approach to treating long-term symptoms associated with traumatic brain injury, stroke, multiple sclerosis, Alzheimer's disease, and Parkinson's disease is neurostimulation. Neurostimulation involves the therapeutic activation of parts of the nervous system. For example, activation can be achieved through electrical, magnetic, or mechanical stimulation. Typical approaches focus on invasive techniques, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), cochlear implants, visual prostheses, and cardiac electrical stimulation devices. Only recently have noninvasive neurostimulation methods become mainstream.

Despite numerous advances in neurorehabilitation and neurostimulation, there remains a critical need for treatments that utilize a combined approach, including both neurorehabilitation and neurostimulation, to improve recovery for patients suffering from traumatic brain injury, stroke, multiple sclerosis, Alzheimer's and Parkinson's diseases, or any other neurologically damaging condition.

Summary of the Invention

In various embodiments, the present invention features methods and devices that combine noninvasive neurorehabilitation with traditional neurorehabilitation. Clinical studies have shown that combining neurostimulation with neurorehabilitation can effectively treat long-term neurological impairments caused by a range of conditions, including traumatic brain injury, stroke, multiple sclerosis, Alzheimer's disease, and Parkinson's disease.

In one aspect, the present invention features a noninvasive neuromodulation system for a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front region and a rear region, the elongated housing having a non-planar outer top surface. The mouthpiece also includes a printed circuit board mounted on the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted within the top of the elongated housing for controlling the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front of the elongated housing and a second end having a connector for connecting to the controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes an electronic socket located at the end of the U-shaped element connected to the cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signals delivered to the patient's tongue.

In some embodiments, the system further includes an accelerometer for measuring the patient's activity level. In some embodiments, the system further includes a data logger for recording information related to the patient's activity level. In some embodiments, the system further includes a tongue sensing circuit for detecting whether the patient's tongue is in contact with a plurality of electrodes located on the bottom of the mouthpiece. In some embodiments, the system further includes a real-time clock for determining the total usage time of the mouthpiece. In some embodiments, the system further includes a battery for supplying current to the mouthpiece. In some embodiments, the system further includes an optical indicator indicating the battery charge level. In some embodiments, the system further includes an audio alarm that can alert the patient when the remaining battery charge is insufficient to complete a course of treatment. In some embodiments, the outer top surface of the elongated housing is flat. In some embodiments, the printed circuit board is mounted to the middle or top portion of the elongated housing. In some embodiments, the control circuit is mounted to the middle or top portion of the elongated housing. In some embodiments, the cable is permanently connected to the controller and removably connected to the mouthpiece.

In another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat top outer surface. The mouthpiece also includes a printed circuit board mounted to the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted within the elongated housing for controlling the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module for delivering current to the electrodes via the control circuit.

The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes a second communication module disposed within the housing and coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals used to determine the amplitude and duration of electrical stimulation energy pulses delivered to the patient's tongue.

In some embodiments, the system further includes an accelerometer for measuring the patient's activity level. In some embodiments, the system further includes a data logger for recording information related to the patient's activity level. In some embodiments, the system further includes tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at the bottom of the mouthpiece. In some embodiments, the system further includes a real-time clock for determining the total usage time of the mouthpiece. In some embodiments, the system further includes a battery for supplying current to the mouthpiece. In some embodiments, the system further includes a light indicator for indicating the battery charge level. In some embodiments, the system further includes an audio alarm for alerting the patient if the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the elongated housing, the bottom portion of the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes control circuitry mounted within the elongated housing for controlling the electrical signals delivered to the electrodes. The system also includes a mobile device configured to send electrical control signals to the mouthpiece, the electrical control signals being used to determine the amplitude and duration of the electrical signals delivered to the patient's tongue.

In some embodiments, the system further includes an accelerometer for measuring the patient's activity level. In some embodiments, the system further includes a data logger for recording information related to the patient's activity level. In some embodiments, the system further includes tongue sensing circuitry for determining whether the patient's tongue is in contact with a plurality of bottom electrodes located on the mouthpiece. In some embodiments, the system further includes a real-time clock for determining the total usage time of the mouthpiece. In some embodiments, the system further includes an audio alarm for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a controller for controlling electrical signals delivered to a mouthpiece during a non-invasive neurorehabilitation therapy session. The controller includes an elongated, U-shaped element configured to rest on a patient's shoulder. The controller also includes an electrical socket at the end of the three-dimensional U-shaped element connected to an electrical cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signals delivered to the patient's tongue.

In some embodiments, the controller further includes an accelerometer for detecting the patient's activity level and a data logger for recording information related to the patient's activity level. In some embodiments, the controller further includes an audio alarm for indicating at least one of the following: the end of a treatment session, a low electrical signal delivered to the patient's tongue, activation/deactivation of the controller, or an interruption of the electrical signal delivered to the tongue. In some embodiments, the controller further includes a power switch for activating and deactivating the controller and one or more intensity buttons for controlling the intensity of the electrical signal delivered by the controller to the mouthpiece. In some embodiments, the controller further includes a display for displaying information and receiving input from the patient. In some embodiments, the controller further includes a battery for providing current to the mouthpiece. In some embodiments, the controller further includes a motor for vibrating the U-shaped element. In some embodiments, the controller further includes at least one printed circuit board for mounting electrical isolation circuitry, battery management circuitry, and a microcontroller; at least one printed circuit board for mounting a work button, a pause button, and an electronic socket; and at least one circuit board for mounting one or more intensity buttons. In some embodiments, the controller further includes circuitry for sensing the current delivered to the patient's tongue through the mouthpiece. In some embodiments, the controller further includes a cable as an integral part of the mouthpiece.

In yet another aspect, the present invention provides a controller for delivering electrical control signals to a mouthpiece during a noninvasive neuromodulation therapy session. The controller includes a spatially extending element positioned proximate to a patient's face. The controller also includes a socket located in the middle of a first surface of the spatially extending element, the socket for providing an electrical and mechanical connection to the mouthpiece. The controller also includes a display located on a second surface of the spatially extending element for providing a visual indication to the patient. The controller also includes a microcontroller located within the spatially extending element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals used to determine the amplitude and duration of electrical signals delivered to the patient's tongue.

In some embodiments, the controller further includes an accelerometer for measuring the patient's activity level and a data logger for recording the patient's activity level, data transmitted to and from the controller, the strength of the electrical signal transmitted to the mouthpiece, and information received to determine whether the patient's tongue is in contact with the mouthpiece. In some embodiments, the controller further includes an audio alarm for indicating one of the following: the end of a treatment session, a low electrical signal transmitted to the patient's tongue, activation/deactivation of the controller, or an interruption of the electrical signal transmitted to the patient's tongue. In some embodiments, the controller further includes a power switch for activating and deactivating the controller and one or more intensity buttons located on a third surface of the space expansion element for controlling the strength of the electrical signal transmitted from the controller to the mouthpiece. In some embodiments, the controller further includes a display for displaying information and receiving input from the patient. In some embodiments, the controller further includes a battery for providing electrical current to the mouthpiece. In some embodiments, the controller further includes a motor for vibrating the space expansion element. In some embodiments, the controller further includes at least one printed circuit board for mounting electrical isolation circuitry, battery management circuitry, and a microcontroller, at least one printed circuit board for mounting a start button and a pause button, at least one printed circuit board for carrying circuitry associated with the receptacle, and at least one circuit board for mounting one or more intensity buttons. In some embodiments, the controller further includes circuitry for sensing electrical current delivered to the patient's tongue through the mouthpiece.

In yet another aspect, the present invention provides a method for providing non-invasive neurorehabilitation therapy to a patient. The method includes connecting a mouthpiece to a controller. The method also includes sending a digital sequence generated by a first processor within the controller to the mouthpiece. The method also includes generating, by a second processor within the mouthpiece, a first hash code based on the received digital sequence and a shared key stored in a memory within the mouthpiece. The method also includes sending the first hash code from the mouthpiece to the controller. The method also includes generating, by the first processor within the controller, a second hash code based on a random number and the shared key. The method also includes comparing, by the first processor, the first hash code and the second hash code. The method also includes enabling electrical communication between the mouthpiece and the controller only when the first hash code matches the second hash code. The method also includes placing the mouthpiece in contact with the patient's oral cavity. The method also includes delivering, by the controller, neurostimulation to the patient's oral cavity via the mouthpiece.

In some embodiments, the method further comprises connecting the mouthpiece to the controller via a cable. In some embodiments, the method further comprises providing power to the controller. In some embodiments, the method further comprises delivering electrical nerve stimulation to the patient's oral cavity via the electrode array.

In yet another aspect, the present invention provides a method for providing non-invasive neurorehabilitation therapy to a patient using a controller and a mouthpiece. The method includes connecting the mouthpiece to the controller. The method also includes generating a first hash code based on a unique serial number and a shared key. The method also includes storing the unique serial number and the first hash code in a memory within the mouthpiece. The method also includes transmitting the first hash code and the unique serial number from the mouthpiece to the controller. The method also includes generating, by a first processor within the controller, a second hash code based on the unique serial number and the shared key. The method also includes enabling electrical communication between the mouthpiece and the controller only when the first and second hash codes match. The method also includes bringing the mouthpiece into contact with the patient's mouth. The method also includes delivering neural stimulation to the patient's mouth, the neural stimulation being delivered by the controller through the mouthpiece.

In some embodiments, the method further comprises connecting the mouthpiece to the controller via a cable. In some embodiments, the method further comprises providing power to the controller. In some embodiments, the method further comprises delivering electrical nerve stimulation to the patient's oral cavity via the electrode array. In some embodiments, the first hash code is a SHA-256 hash code.

In another aspect, the present invention provides a mouthpiece for providing neurorehabilitation therapy to a patient. The mouthpiece receives electrical nerve stimulation signals from a controller and selectively transmits the received electrical nerve stimulation signals to the patient. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted on the top of the elongated housing and configured to control the electrical signals transmitted to the electrodes. The mouthpiece also includes a memory mounted on the top of the elongated housing. The mouthpiece also includes a processor mounted on the top of the elongated housing, the processor configured to (i) receive a digital sequence from the controller, (ii) generate a first hash code based on the received digital sequence and a shared key stored in the memory, (iii) transmit the first hash code to the controller, and (iv) receive a communication from the controller only if a second hash code generated by the controller based on the digital sequence and the shared key matches the first hash code.

In yet another aspect, the present invention provides a mouthpiece for providing neurorehabilitation therapy to a patient, the mouthpiece receiving electrical nerve stimulation signals from a controller and selectively transmitting the received electrical nerve stimulation signals to the patient. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes control circuitry mounted on the top of the elongated housing for controlling the electrical signals delivered to the electrodes. The mouthpiece also includes a memory mounted on the top of the elongated housing. The mouthpiece also includes a processor mounted within the top of the elongated housing, configured to (i) store a first hash code and a unique serial number, the first hash code generated based on the unique serial number and a shared key; (ii) transmit the first hash code and unique serial number to the controller; and (iii) receive a communication from the controller only when a second hash code generated by the controller based on the unique serial number and a shared key matches the first hash code. In some embodiments, the first hash code is a SHA-256 hash code.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front portion of the elongated housing and a second end having a connector for connecting to the controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element having a first arm and a second arm separating a rear portion from a front portion. The front portion of the elongated U-shaped element has a first distance from one of the arms and a first mass, and the rear portion of the elongated U-shaped element has a second distance from the other of the arms and a second mass, wherein the product of the first distance and the first mass is greater than the product of the second distance and the second mass. The controller also includes an electronics receptacle located at a front portion of the U-shaped element and connected to the electrical cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send an electrical control signal to the mouthpiece, the electrical control signal used to determine the amplitude and duration of the electrical signal delivered to the patient's tongue.

In some embodiments, the width of the elongated U-shaped element corresponds to approximately the sixtieth percentile of an adult male neck width. In some embodiments, the length of the elongated U-shaped element is approximately 200 mm. In some embodiments, the width of the elongated U-shaped element is approximately 120 mm. In some embodiments, the front portion includes a first portion having a first width of approximately 35 mm and a second portion having a second width of approximately 35 mm, the first portion being connected to the first arm, and the second portion being connected to the second arm. In some embodiments, the first mass is greater than the second mass. In some embodiments, the first mass is less than the second mass. In some embodiments, the first and second distances are determined by the portion of the arm configured to contact the patient's shoulder. In some embodiments, the radius of curvature of the arm in the patient's sagittal plane is in the range of 20-30 cm so that the controller substantially conforms to the patient's shoulder. In some embodiments, the width of the elongated U-shaped element is between 60% and 80% of the length of the elongated U-shaped element. In some embodiments, the width of the elongated U-shaped element is approximately 60% of the length of the elongated U-shaped element. In some embodiments, the radius of curvature of the inner contour of the rear portion in the transverse plane of the patient is in the range of 20-60 mm. In some embodiments, the radius of curvature of the inner contour of the rear portion in the transverse plane of the patient is approximately 40 mm. In some embodiments, the radius of curvature of the outer contour of the rear portion in a transverse plane of the patient is within a range of 10-40 mm. In some embodiments, the radius of curvature of the outer contour of the rear portion in a transverse plane of the patient is approximately 25 mm. In some embodiments, the radius of curvature of the contour of the first and second arms in a transverse plane of the patient is within a range of 330-430 mm. In some embodiments, the radius of curvature of the contour of the first and second arms in a transverse plane of the patient is approximately 380 mm. In some embodiments, the front portion includes an opening having a width of approximately 30-60 mm. In some embodiments, the front portion includes an opening having a width of approximately 45 mm. In some embodiments, the system includes an accelerometer for measuring the patient's activity level. In some embodiments, the system includes a data logger for recording information related to the patient's activity level. In some embodiments, the system includes tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at the bottom of the mouthpiece. In some embodiments, the system includes a clock for determining the total usage time of the mouthpiece. In some embodiments, the system includes a battery for supplying current to the mouthpiece. In some embodiments, the system includes a light indicator to indicate the battery charge level. In some embodiments, the system includes an audible alarm to warn the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention features a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes control circuitry mounted within the elongated housing for controlling the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module for providing current to the electrodes via the control circuitry. The controller includes an elongated U-shaped element having a first arm extending from a rear portion to a front portion and a second arm, the front portion of the elongated U-shaped element being located at a first distance from one of the arms and having a first mass, and a rear portion of the elongated U-shaped element being located at a second distance from the other arm and having a second mass, the product of the first mass being greater than the product of the second mass and the second distance being greater. The controller also includes a second communication module within the housing coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals used to determine the amplitude and duration of electrical stimulation energy pulses delivered to the patient's tongue.

In some embodiments, the system includes an accelerometer for measuring the patient's activity level. In some embodiments, the system includes a data logger for recording information related to the patient's activity level. In some embodiments, the system includes tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at the base of the mouthpiece. In some embodiments, the system includes a clock for determining the total usage time of the mouthpiece. In some embodiments, the system includes a battery for providing current to the mouthpiece. In some embodiments, the system includes a light indicator to indicate the battery charge level. In some embodiments, the system includes an audio alarm to alert the patient when the remaining battery charge is insufficient to complete a treatment session. In some embodiments, the width of the elongated U-shaped element corresponds to approximately the 60th percentile of adult male neck width. In some embodiments, the length of the elongated U-shaped element is approximately 200 mm. In some embodiments, the width of the elongated U-shaped element is approximately 120 mm. In some embodiments, the front portion includes a first portion having a first width of approximately 35 mm and a second portion having a second width of approximately 35 mm, the first portion being connected to the first arm, and the second portion being connected to the second arm. In some embodiments, the first mass is greater than the second mass. In some embodiments, the first mass is less than the second mass. In some embodiments, the first and second distances are determined by the portion of the arm configured to contact the patient's shoulder. In some embodiments, the radius of curvature of the arm in the patient's sagittal plane is in the range of 20-30 centimeters, so that the controller substantially conforms to the patient's shoulder. In some embodiments, the width of the elongated U-shaped element is between 60% and 80% of the length of the elongated U-shaped element. In some embodiments, the width of the elongated U-shaped element is approximately 60% of the length of the elongated U-shaped element. In some embodiments, the radius of curvature of the inner contour of the posterior portion in the transverse plane of the patient is in the range of 20-60 millimeters. In some embodiments, the radius of curvature of the inner contour of the posterior portion in the transverse plane of the patient is approximately 40 millimeters. In some embodiments, the radius of curvature of the outer contour of the posterior portion in the transverse plane of the patient is in the range of 10-40 millimeters. In some embodiments, the radius of curvature of the outer contour of the posterior portion in the transverse plane of the patient is approximately 25 millimeters. In some embodiments, the radius of curvature of the contours of the first and second arms in the transverse plane of the patient is in the range of 330-430 millimeters. In some embodiments, the radius of curvature of the contours of the first and second arms in the transverse plane of the patient is approximately 380 millimeters. In some embodiments, the front portion includes an opening having a width of about 30-60 mm. In some embodiments, the front portion includes an opening having a width of about 45 mm.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front portion of the elongated housing and a second end having a connector for connecting to the controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes an electronic socket located at the end of the U-shaped element connected to the cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signals delivered to the patient's tongue. The controller also includes an accelerometer for measuring the patient's activity level.

In some embodiments, the system further comprises at least one of the following: a data logger for recording data related to the patient's activity level, a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece, a clock for determining the total usage time of the mouthpiece, or an audio alarm for alerting the patient when the remaining battery charge is insufficient to complete a treatment session. In some embodiments, the system further comprises a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front portion of the elongated housing and a second end having a connector for connecting to the controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes an electronics socket located at the end of the U-shaped element connected to the cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signals delivered to the patient's tongue. The controller also includes a data logger for recording information related to the patient's activity level.

In some embodiments, the system further comprises at least one of the following: a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece, a clock for determining the total usage time of the mouthpiece, or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front portion of the elongated housing and a second end having a connector connected to the controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes an electronic socket located at the end of the U-shaped element connected to the cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signals delivered to the patient's tongue. The controller also includes tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at the bottom of the mouthpiece.

In some embodiments, the system further comprises at least one of a clock for determining the total usage time of the mouthpiece or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front portion of the elongated housing and a second end having a connector for connecting to the controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes an electronic socket located at the end of the U-shaped element connected to the cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signals delivered to the patient's tongue. The controller also includes a clock for determining the total usage time of the mouthpiece.

In some embodiments, the controller further includes an audio alarm for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a cable having a first end connected to the front portion of the elongated housing and a second end having a connector connected to a controller, the cable delivering current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder.

The controller also includes an electronics receptacle located at the end of the U-shaped element connected to the cable. The controller also includes a microcontroller located within the three-dimensional U-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining the amplitude and duration of the electrical signal delivered to the patient's tongue. The controller also includes an audio indicator to alert the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module that transmits current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes a second communication module disposed within the housing and coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece for determining the amplitude and duration of the electrical stimulation energy pulses delivered to the patient's tongue. The system also includes an accelerometer for measuring the patient's activity level.

In some embodiments, the system further comprises at least one of the following: a data logger for recording information related to the patient's activity level; a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece; a clock for determining the total usage time of the mouthpiece; or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session. In some embodiments, the system further comprises a data logger for recording information related to the patient's activity level.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module that transmits current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes a second communication module disposed within the housing and coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece for determining the amplitude and duration of the electrical stimulation energy pulses delivered to the patient's tongue. The controller also includes a data logger for recording information related to the patient's activity level.

In some embodiments, the system further comprises at least one of the following: a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece, a clock for determining the total usage time of the mouthpiece, or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module that delivers current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes a second communication module disposed within the housing and coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece for determining the amplitude and duration of the electrical stimulation energy pulses delivered to the patient's tongue. The controller also includes a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece.

In some embodiments, the system further comprises at least one of a clock for determining the total usage time of the mouthpiece or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module that transmits current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes a second communication module disposed within the housing and coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece for determining the amplitude and duration of the electrical stimulation energy pulses delivered to the patient's tongue. The controller also includes a clock for determining the total usage time of the mouthpiece.

In some embodiments, the system further includes an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The mouthpiece also includes a first communication module that transmits current to the electrodes via the control circuit. The controller includes an elongated U-shaped element configured to rest on the patient's shoulder. The controller also includes a second communication module disposed within the housing and coupled to and in communication with the first communication module. The controller also includes a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece for determining the amplitude and duration of the electrical stimulation energy pulses delivered to the patient's tongue. The controller also includes an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes control circuitry mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The controller includes a mobile device configured to send electrical control signals to the mouthpiece, the electrical control signals being used to determine the amplitude and duration of the electrical signals delivered to the patient's tongue. The system also includes an accelerometer for measuring the patient's activity level.

In some embodiments, the system further comprises at least one of the following: a data logger for recording information related to the patient's activity level; a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece; a clock for determining the total usage time of the mouthpiece; or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session. In some embodiments, the system further comprises a tongue sensing circuit for determining whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece and a data logger for recording information related to the patient's activity level.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes control circuitry mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The controller includes a mobile device configured to send electrical control signals to the mouthpiece, the electrical control signals being used to determine the amplitude and duration of the electrical signals delivered to the patient's tongue. The controller also includes a data logger for recording information related to the patient's activity level.

In some embodiments, the system further comprises at least one of the following: a tongue sensing circuit for detecting whether the patient's tongue is in contact with the plurality of electrodes located at the bottom of the mouthpiece, a clock for determining the total usage time of the mouthpiece, or an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes control circuitry mounted on the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The controller includes a mobile device configured to send electrical control signals to the mouthpiece, the electrical control signals being used to determine the amplitude and duration of the electrical signals delivered to the patient's tongue. The mouthpiece also includes tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at the bottom of the mouthpiece.

In some embodiments, the system further includes one of a clock for determining the total usage time of the mouthpiece or an audio indicator that warns the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The controller includes a mobile device configured to send electrical control signals to the mouthpiece, the electrical control signals being used to determine the amplitude and duration of the electrical signals delivered to the patient's tongue. The controller also includes a clock for determining the total usage time of the mouthpiece.

In some embodiments, the system further includes an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session.

In yet another aspect, the present invention provides a system for providing non-invasive neurorehabilitation therapy to a patient. The system includes a mouthpiece and a controller. The mouthpiece includes an elongated housing having a front portion and a rear portion, the elongated housing having a non-flat outer top surface. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue. The mouthpiece also includes a control circuit mounted to the top of the elongated housing and configured to control the electrical signals delivered to the electrodes. The controller includes a mobile device configured to send an electrical control signal to the mouthpiece, the electrical control signal being used to determine the amplitude and duration of the electrical signal delivered to the patient's tongue. The controller also includes an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment course.

As used herein, the terms "approximately," "roughly," and "substantially" mean ±10%, and in some embodiments, ±5%. Descriptions with reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" mean that the specific features, structures, procedures, steps, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, procedures, steps, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the claimed technology.

BRIEF DESCRIPTION OF THE DRAWINGS

The advantages described above and further advantages of the present invention may be better understood from the following description taken in conjunction with the accompanying drawings, which are not necessarily drawn to scale, emphasis instead generally being placed upon illustrating the principles of the invention.

FIG1 is a schematic diagram showing a non-invasive neurostimulation treatment session for a patient according to an exemplary embodiment of the present invention.

2A and 2B illustrate a neural stimulation system according to an exemplary embodiment of the present invention.

FIG. 2C shows a schematic diagram of a neural stimulation system according to an exemplary embodiment of the present invention.

FIG. 3A shows a more detailed view of the neural stimulation system depicted in FIGs. 2A and 2B .

FIG. 3B is a more detailed view of the neural stimulation system depicted in FIG. 2C .

FIG3C shows a more detailed view of the electrode array.

FIG3D shows a graph of an exemplary sequence of neural stimulation pulses for affecting a patient.

4A shows a flow chart of a method for operating a neural stimulation system according to one embodiment of the present invention.

4B shows a flow chart of a method for operating a neural stimulation system according to one embodiment of the present invention.

FIG. 5A shows a schematic diagram of a neural stimulation system according to one embodiment of the present invention.

FIG5B shows a schematic diagram of a controller according to an exemplary embodiment of the present invention.

5C illustrates a flow chart of a method of operating a neural stimulation system according to one embodiment of the present invention.

6A and 6B show schematic diagrams of a neural stimulation system according to one embodiment of the present invention.

7A and 7B show schematic diagrams of a neural stimulation system according to one embodiment of the present invention.

8A and 8B show schematic diagrams of a neural stimulation system according to one embodiment of the present invention.

9A shows a flow chart of a method for operating a neural stimulation system according to one embodiment of the present invention.

9B illustrates a flow chart of a method for operating a neural stimulation system according to one embodiment of the present invention.

10A-10D are schematic diagrams of a controller according to an exemplary embodiment of the present invention.

DETAILED DESCRIPTION

FIG1 illustrates a schematic diagram of a non-invasive neurostimulation therapy session (NINM) performed on a patient 101 using a neurostimulation system 100. During a therapy session, the neurostimulation system 100 non-invasively stimulates various nerves located within the patient's oral cavity, including at least one of the trigeminal nerve and the facial nerve. In conjunction with the NINM, the patient also engages in exercise or other activities specifically designed to assist with the patient's neurological rehabilitation. For example, during the NINM, the patient may engage in physical therapy procedures (e.g., moving the affected limb or walking on a treadmill), psychotherapy (e.g., meditation or breathing exercises), or cognitive exercises (e.g., computer-assisted memory exercises). The combination of NINM and appropriately selected exercises or activities has been shown to be useful for treating a range of conditions, including, for example, traumatic brain injury, stroke (TBI), multiple sclerosis (MS), balance, gait, vestibular disorders, visual impairments, tremors, headaches, migraines, neuropathic pain, hearing loss, speech recognition, auditory problems, speech therapy, cerebral palsy, blood pressure, relaxation, and heart rate. For example, U.S. Patent No. 8,849,407 describes a recently developed and effective non-invasive neurorehabilitation (NINM) treatment routine, the entire contents of which are incorporated herein by reference.

Figures 2A and 2B illustrate a noninvasive neurostimulation system 100. The noninvasive neurostimulation system 100 includes a controller 120 and a mouthpiece 140. The controller 120 includes a socket 126 and a button 122. The mouthpiece 140 includes an electrode array 142 and a cable 144. The cable 144 connects to the socket 126 to electrically connect the mouthpiece 140 to the controller 120. In some embodiments, the controller 120 includes a cable. In some embodiments, the mouthpiece 140 and the controller 120 are wirelessly connected (e.g., without a cable). During operation, the patient activates the neurostimulation system 100 by pressing one of the buttons 122. In some embodiments, the neurostimulation system 100 periodically sends electrical pulses to detect whether the electrode array 142 is in contact with the patient's tongue and automatically activates based on this determination. After activation, the patient can start, stop, or pause a NIM therapy session by pressing one of the buttons 122. In some embodiments, the neurostimulation system 100 periodically sends electrical pulses to detect whether the electrode array 142 is in contact with the patient's tongue and automatically pauses the NIM therapy session based on the detection result.

During a NIMM treatment session, the patient may engage in exercise or other activities designed to promote neurorehabilitation. For example, during NIMM treatment, the patient may engage in physical, psychomotor, or cognitive exercises. In some embodiments, the controller 120 has buttons on both arms. In some embodiments, a mobile device can be used in conjunction with the controller 120 and the mouthpiece 140. The mobile device can have a software application that allows the user to activate the neurostimulation system 100 and start or stop a NIMM treatment session, for example, by pressing a button on the mobile device or speaking a command into the mobile device. The mobile device can access the patient's medical history or treatment session information before, during, or after a NIMM treatment session. In some embodiments, the controller 120 includes a secure cryptographic processor that stores a secret key, which will be described in more detail below in conjunction with Figures 9A and 9B. The secure cryptographic processor communicates with the microcontroller. The secure cryptographic processor is tamper-resistant. For example, if someone removes the exterior of the cryptographic processor in an attempt to access the secret key, the cryptographic processor will erase all memory, thereby preventing unauthorized access to the secret key.

FIG2C illustrates a noninvasive neurostimulation system 100. As shown, a mobile device 121 communicates with a mouthpiece 140. More specifically, the mobile device 121 includes a processor that runs a software application that facilitates communication with the mouthpiece 140. The mobile device 121 may be, for example, a mobile phone, a portable digital assistant (PDA), or a laptop computer. The mobile device 121 may communicate with the mouthpiece 140 via a wireless or wired connection. During operation, a patient may activate the neurostimulation system 100 via the mobile device 121. After activation, the patient may start, stop, or pause a NINM therapy session by manipulating the mobile device 121. During a NINM therapy session, the patient may engage in exercise or other activities designed to assist in neurorehabilitation. For example, during NINM therapy, the patient may engage in physical, psychomotor, or cognitive exercises.

FIG3A illustrates the internal circuitry housed within controller 120. This circuitry includes a microcontroller 360, isolation circuitry 379, a universal serial bus (USB) connection 380, a battery management controller 382, a battery 362, a button interface 364, a display 366, a real-time clock 368, an accelerometer 370, a driver circuit 372, a tongue sensing circuit 374, an audio feedback circuit 376, a vibration feedback circuit 377, and non-volatile memory 378. The driver circuit 372 includes a multiplexer and resistor array to control the voltage delivered to the electrode array 142. The microcontroller 360 is electrically connected to each of the components shown in FIG3A. The isolation circuit 379 provides electrical isolation between the USB connection 380 and all other components included in controller 120. Furthermore, the circuitry shown in FIG3A is communicatively connected to the mouthpiece 140 via an external cable 144. During operation, the microcontroller 360 receives power from the battery 362 and can store and read information from the non-volatile memory 378. The battery can be recharged via USB connection 380. Battery management circuitry controls the charging of battery 362. A patient can interact with controller 120 via button interface 122. Controller 120 converts patient button presses (e.g., information button, power button, intensity increase button, intensity decrease button, and start/stop button) into electrical signals that are transmitted to microcontroller 360. For example, a therapy session can be initiated when a patient presses the start/stop button after controller 120 is powered on. During a therapy session, driver circuit 372 provides an electrical signal to mouthpiece 140 via cable 144. This signal is transmitted to the patient's oral cavity via electrode array 142. Accelerometer 370 can be used to provide information about the patient's movement during a therapy session. Information provided by accelerometer 370 can be stored in non-volatile memory 378 at a coarse or detailed level. A comprehensive motion index for the therapy session can be stored, for example, based on the number of times acceleration rises above a predetermined threshold, with or without low-pass filtering. Optionally, acceleration readings can be stored at predetermined sampling intervals. Information provided by the accelerometer 370 can be used to determine whether the patient is engaging in physical activity. Based on the information received from the accelerometer 370, the microcontroller 360 can determine the patient's activity level during a therapy session. For example, if the patient engages in physical activity for 30 minutes during a therapy session, the accelerometer 370 can periodically (e.g., once per second) transmit to the microcontroller 360 any sensed motion greater than a predetermined threshold (e.g., greater than 1 m/s²). In some embodiments, accelerometer data is stored in non-volatile memory 378 during the therapy session and transmitted to the mobile device 121 after the therapy session. After the therapy session is completed, the microcontroller 360 can record the time at which the patient's activity was recorded during the therapy session. In some embodiments, the recorded information can include other data about the therapy session (e.g., the date and time the session began, the average intensity of the electrical nerve stimulation delivered to the patient during the session, the patient's average activity level during the session, the duration of the session with the mouthpiece in the patient's mouth, the duration of the session pauses, the number of session shorting events, and/or the length of the session or the type of motion or activity engaged in during the therapy session) and can be transmitted to the mobile device. If the current sent from the driver circuit to the electrode array 142 exceeds a predetermined threshold, or if the charge transferred from the driver circuit to the electrode array exceeds a predetermined threshold within a predetermined time interval, a therapy session short-circuit event occurs. After a therapy session short-circuit event occurs, the patient must manually press a button to resume therapy. A real-time clock (RTC) 368 provides time and date information to the microcontroller 360. In some embodiments, the controller 120 is authorized by a physician within a predetermined time period (e.g., two weeks). The RTC 368 periodically provides date and time information to the microcontroller 360. In some embodiments, the RTC 368 is integrated with the microcontroller. In some embodiments, the RTC 368 is powered by a battery 362, and in the event of battery 362 failure, the RTC 368 is powered by a backup battery. After the predetermined time period, the controller 120 may no longer send electrical signals to the mouthpiece 140, and the patient must visit a physician to regain authorization to use the controller 120. Information received by the microcontroller 360 is displayed to the patient via a display 366. For example, the display 366 can show the time of day, treatment information, battery information, remaining time in a treatment session, error messages, and the status of the controller 120. When the device's status changes, the audio feedback circuit 376 and the vibration feedback circuit 377 can provide feedback to the user. For example, when a treatment session begins, the audio feedback circuit 376 and the vibration feedback circuit 377 can provide an auditory and/or vibratory prompt to the patient, notifying them that the treatment session has begun. Other possible status changes that can trigger an audio and/or vibratory prompt include pausing a treatment session, resuming a treatment session, ending a treatment session, canceling a treatment session, or an error message. In some embodiments, the clinician can disable one or more of the auditory or vibratory feedback prompts to suit the needs of a particular patient. The tongue sensing circuit 374 measures the current flowing from the driver circuit to the electrode array 142. Upon detecting a current above a predetermined threshold, the tongue sensing circuit 374 sends a high level to the microcontroller 360, indicating that the tongue is in contact with the electrode array 142. If the current is below a predetermined threshold, the tongue sensing circuit 374 signals a low level to the microcontroller 360, indicating that the tongue is not in contact or is partially in contact with the electrode array 142. The indication received from the tongue sensing circuit 374 can be stored in the non-volatile memory 378. In some embodiments, the display 366 can be an organic light-emitting diode (OLED) display. In some embodiments, the display 366 can be a liquid crystal display (LCD). In some embodiments, the display 366 does not include a connection to the controller 120. In some embodiments, neither the controller 120 nor the mouthpiece 140 includes a cable, and the controller 120 and mouthpiece 140 communicate wirelessly. In some embodiments, neither the controller 120 nor the mouthpiece 140 includes an accelerometer. In some embodiments, the drive circuit 372 is located within the mouthpiece. In some embodiments, a portion of the drive circuit 372 is located within the mouthpiece 140 and a portion of the drive circuit 372 is located within the controller 120. In some embodiments, neither the controller 120 nor the mouthpiece 140 includes the tongue sensing circuit 374. In some embodiments, the mouthpiece 140 includes a microcontroller and a multiplexer.

FIG3B shows a more detailed view of FIG2C . The mouthpiece 140 includes a battery 362, tongue sensing circuitry 374, an accelerometer 370, a microcontroller 360, a driver circuit 372, a non-volatile memory 378, a USB controller 380, and a battery management circuit 382. During operation, the microcontroller receives power from the battery 362 and can store and read information from the non-volatile memory 378. The battery can be recharged via the USB connection 380. The battery management circuit 382 controls the charging of the battery 362. The patient can interact with the mouthpiece 140 via the mobile device 121. The mobile device 121 includes an application (e.g., software running on a processor) that allows the patient to control the mouthpiece 140. For example, the application may include a visual information button, a power button, an intensity increase button, an intensity decrease button, and a start/stop button displayed to the user via the mobile device 121. When the patient presses a button displayed by the application running on the mobile device 121, a signal is sent to the microcontroller 360 housed within the mouthpiece 140. For example, a patient can initiate a therapy session by pressing a start/stop button on the mobile device 121. During a therapy session, the driver circuit 372 provides electrical signals to the electrode array 142 located on the mouthpiece 140. The accelerometer 370 can be used to provide information about the patient's movement during the therapy session. The information provided by the accelerometer 370 can be used to determine whether the patient is physically active. Based on the information received from the accelerometer 370, the microcontroller 360 can determine the patient's activity level during the therapy session. For example, if the patient engages in physical activity for 30 minutes during a therapy session, the accelerometer 370 can periodically (e.g., once per second) transmit to the microcontroller 360 any sensed movement greater than a predetermined threshold (e.g., greater than 1 m/s²). After the therapy session is complete, the microcontroller 360 can record the time the patient's activity was recorded during the therapy session. In some embodiments, the accelerometer 370 is located within the mobile device 121, and the mobile device 121 determines the patient's activity level during the therapy session based on the information from the accelerometer 370. The mobile device can then record the patient's activity time during the treatment session. The mobile device 121 includes a real-time clock 368 that provides time and date information to the microcontroller 360. In some embodiments, the mouthpiece 140 is authorized by a physician for a predetermined period of time (e.g., two weeks). After the predetermined period of time, the mouthpiece 140 no longer transmits electrical signals to the patient via the electrode array 142, and the patient must visit a physician to re-authorize the use of the mouthpiece 140. In some embodiments, the mouthpiece 140 includes a button (e.g., an on/off button) that the patient can manually operate. After a treatment session, the mouthpiece 140 can transmit information about the treatment session to the mobile device. In some embodiments, the mouthpiece 140 does not include a USB controller 380 and communicates with the controller solely via wireless communication.

FIG3C shows a more detailed view of electrode array 142. Electrode array 142 can be divided into nine groups of electrodes, labeled a through i. Each group contains 16 electrodes, except for group b, which has 15 electrodes. Each electrode within a group corresponds to one of the 16 electrical channels. During operation, a driver circuit can deliver a sequence of electrical pulses to electrode array 142 to provide neural stimulation to at least one of the patient's trigeminal nerve or facial nerve. The amplitude of the electrical pulses delivered to each group of electrodes near the front of the tongue is larger, while the amplitude of the electrical pulses delivered to each group of electrodes near the back of the tongue is smaller. For example, the pulse amplitude of the electrical signals delivered to groups a through c can be 19 volts, or 100% of the maximum value; the pulse amplitude of the electrical signals delivered to groups d through f can be 14.25 volts, or 75% of the maximum value; the pulse amplitude of the electrical signals delivered to groups g through h can be 11.4 volts, or 60% of the maximum value; and the pulse amplitude of the electrical signals delivered to group i can be 9.025 volts, or 47.5% of the maximum value. In some embodiments, the maximum voltage is in the range of 0 to 40 volts. The pulses delivered to the patient by the electrode array 142 can be random or repetitive. The location of the pulses can vary across the electrode array 142 so that different electrodes are activated at different times, and the duration and/or intensity of the pulses can also vary from electrode to electrode. For oral tissue stimulation, a current of 0.5 to 50 mA and a voltage of 1 to 40 V can be used. In some embodiments, the transient current can be greater than 50 mA. The stimulation waveform can have various time-related forms, and for skin electrical stimulation, pulse trains and pulse bursts can be used. When the pulses are provided continuously, the pulses can be 1 to 500 microseconds long and can be repeated at a rate of 1 to 1000 pulses/second. When the pulses are delivered in bursts, the pulses can be grouped into 1 to 100 pulses/burst and delivered at a burst rate of 1 to 100 bursts/second.

In some embodiments, a pulse waveform is delivered to electrode array 142. FIG3D illustrates an exemplary pulse sequence that can be delivered to electrode array 142 by driver circuit 372. Three pulse trains are delivered to each of the 16 channels, each separated by 5 milliseconds. Pulses in adjacent channels are separated by 312.5 microseconds. The pulse train repeats every 20 milliseconds. The width of each pulse can be varied from 0.3 to 60 microseconds to control the intensity of neural stimulation (e.g., a pulse with a width of 0.3 microseconds will result in less neural stimulation than a pulse with a width of 60 microseconds).

FIG4A illustrates a method 400 for operating the controller 120 described in FIG2A , 2B , and 3A . The patient connects the mouthpiece 140 to the controller 120 (step 404 ). The patient turns on the controller 120 by, for example, using the power button (step 408 ). The patient places the controller 120 around their neck (step 412 ), as shown in FIG1B . The patient places the mouthpiece 140 in their mouth (step 416 ). The patient initiates a therapy session by pressing the start/stop button (step 420 ). During the therapy session, the controller 120 provides an electrical signal to the mouthpiece 140. The patient calibrates the intensity of the electrical signal (step 424 ). The patient increases the intensity of the electrical signal delivered to the mouthpiece by pressing the intensity increase button until the neurostimulation is above the patient's sensitivity level. The patient can press the intensity decrease button until the neurostimulation is comfortable and pain-free. After the calibration step, the patient can perform prescribed exercises (step 428 ). The exercises can be cognitive, mental, or physical. In some embodiments, physical exercises may include the patient attempting to maintain a normal gait, or moving his/her limbs, or the patient undergoing speech training. Cognitive exercises may include "brain training" exercises, often computerized, designed to require the use of attention, memory, or reading comprehension. Mental exercises may include imagery, meditation, relaxation techniques, and gradually approaching compulsive behavior "triggers."

In some embodiments, the patient can rest for a period of time during a treatment session (e.g., a patient can rest for 2 minutes during a 30-minute treatment session). After a predetermined period of time (e.g., 30 minutes) has elapsed, the treatment session ends (step 432), and the controller 120 stops transmitting the electrical signal to the mouthpiece 140. In some embodiments, after the patient initiates a treatment session by pressing the start/stop button, the electrical signal intensity increases continuously from zero to the last level selected by the patient over a period of 1 to 5 seconds. In some embodiments, after the patient initiates a treatment session by pressing the start/stop button, the electrical signal intensity can be set to a fraction of the last level selected by the patient (e.g., 3/4 of the last level selected). In some embodiments, after the patient initiates a treatment session by pressing the start/stop button, the electrical signal intensity increases continuously from zero to a fraction of the last level selected by the patient (e.g., 3/4 of the last level selected) over a period of 1 to 5 seconds. In some embodiments, after the patient initiates a treatment session by pressing the start/stop button, the electrical signal intensity increases instantaneously from zero to the last level selected by the patient.

In some embodiments, the mouthpiece 140 is connected to the controller 120 after the controller 120 is turned on. In some embodiments, the mouthpiece 140 is connected to the controller 120 after the patient wears the controller 120. In some embodiments, the patient calibrates the strength of the electrical signal before starting a treatment session. In some embodiments, the patient performs an initial calibration of the strength of the electrical signal in the presence of a clinician and does not calibrate the strength of the electrical signal during subsequent treatment sessions without the presence of a clinician.

FIG4B illustrates a method 449 for operating the noninvasive neurostimulation system 100 of FIG2C and FIG3B . The patient activates the mobile device 121 (step 450 ). The patient places the mouthpiece 140 in their mouth (step 454 ). The patient presses the start/stop button in the app running on the mobile device 121 to initiate a therapy session (step 458 ). During the therapy session, circuitry within the mouthpiece 140 provides electrical signals to the electrode array 142 located therein. The patient calibrates the intensity of the electrical signals (step 462 ). The patient first increases the intensity of the electrical signals delivered to the mouthpiece 140 by pressing the intensity increase button within the app running on the mobile device 121 until the neurostimulation is above the patient's sensitivity level. The patient can then press the intensity decrease button within the app running on the mobile device 121 until the neurostimulation is comfortable and pain-free. After the calibration step, the patient engages in a prescribed exercise (step 464 ). The exercise can be cognitive, mental, or physical. In some embodiments, the patient may take a break for a period of time during a treatment session (e.g., a patient may take a 5-minute break during a 30-minute treatment session). After a predetermined period of time (e.g., 30 minutes) has elapsed, the treatment session ends (step 468) and the circuitry within mouthpiece 140 stops delivering electrical signals to electrode array 142. In some embodiments, a calibration of the strength of the electrical signal is performed before the patient initiates a treatment session.

FIG5A shows a neurostimulation system 500, and FIG5B shows a rear view of a controller 520. Neurostimulation system 500 includes controller 520 and a mouthpiece 540 connected to controller 520 via a cable 544. Mouthpiece 540 includes an electrode array on its bottom. Controller 520 includes a front portion 560 and a back portion 564. Controller 520 also includes a mouthpiece port 516, an intensity increase button 508, an intensity decrease button 512, a power button 521, an information button 524, a start/stop button 504, and a display 528. Mouthpiece 540 is in electrical communication with controller 520 via cable 544. In some embodiments, power button 521 includes a light-emitting diode (LED) indicator. In some embodiments, port 516 is located on mouthpiece 540 rather than controller 520, and cable 544 is permanently connected to controller 520. In some embodiments, the port is a universal serial bus (USB) port and/or a charging port.

FIG5C illustrates the method 200 for operating the neurostimulation system 500 shown in FIG5A and FIG5B . The patient activates the neurostimulation system 500 by pressing the power button 521 (step 208 ). Upon activation, the neurostimulation system 500 enters an idle state (step 212 ). In the idle state, noninvasive neurostimulation is not delivered to the patient. If the neurostimulation system 500 remains in the idle state for a predetermined period of time, the neurostimulation system 500 may shut down or enter a power-saving state (e.g., after idling for 10 minutes). Furthermore, if the power button 521 is pressed during the idle state, the neurostimulation system 500 shuts down. If the patient presses the start button (step 224 ), a NMN therapy session begins, and noninvasive neurostimulation generated by the controller 520 is delivered to the patient's oral cavity via the mouthpiece 540 for a predetermined period of time. In some embodiments, when the patient presses the start button (step 224 ), the neurostimulation system 500 enters an intensity adjustment state. The patient then presses the intensity increase button 508 to increase the intensity of the electrical signal delivered to the mouthpiece until the neurostimulation is above the patient's sensitivity level. The patient presses the intensity reduction button 512 until the neurostimulation is comfortable and pain-free. After the intensity adjustment is complete, the patient presses the start button again to begin the NIMN therapy session. In one embodiment, the predetermined time period can be a user-selectable range of approximately 20-30 minutes. Additionally, the patient can engage in physical, cognitive, or mental exercises during the NIMN therapy session. The physical, cognitive, or mental exercises are performed simultaneously with the transmission of electrical signals from the controller 520 to the mouthpiece 540. While delivering neurostimulation, if the patient presses the pause button (step 232), the therapy session is paused (step 233) and the neurostimulation system 500 stops providing non-invasive neurostimulation to the patient's mouth. In some embodiments, if the neurostimulation system 500 loses contact with the patient's mouth (e.g., as determined by tongue sensing circuitry), the therapy session is paused. If the patient presses the unpause button (step 234), therapy resumes and non-invasive neurostimulation is again delivered to the patient's mouth. If the patient presses the stop button while neurostimulation system 500 is paused, or if there is no patient input for a predetermined period of time, such as two minutes, after the patient has pressed the pause button (step 235), neurostimulation system 500 enters an idle state (step 212) and displays a message "Treatment ended due to pause timeout" on display 528. If the patient presses the stop button while neurostimulation is being delivered (step 240), neurostimulation system 500 enters an idle state (step 212) and displays a message "Treatment ended due to session pause" on display 528. Alternatively, if the predetermined period of time during which neurostimulation system 500 has been providing neurostimulation to the patient expires in step 240, the system enters the idle state of step 212 and displays a message "Full session completed" on display 528.

While the system is in the idle state in step 212, certain conditions may prevent the patient from initiating a therapy session. For example, if the remaining battery charge is insufficient to complete at least one NIMM therapy session, the controller 520 may prevent the patient from initiating a therapy session and display a "low battery" message on the display 528. In some embodiments, the controller may emit an audible tone to alert the patient that the remaining battery charge is insufficient to complete at least one NIMM therapy session. Additionally, if the mouthpiece 540 is not connected to the controller 520, the controller 520 may prevent the patient from initiating a therapy session and display a "no mouthpiece" message on the display 528.

In some embodiments, neurostimulation system 500 may have a daily limit on the amount of time it can provide neurostimulation. For example, neurostimulation system 500 may be configured to disable neurostimulation after 200 minutes of use in a single day. During the idle state of step 212, if the daily limit is exceeded, controller 520 may prevent the patient from starting a therapy session and display "Daily Limit Reached" on display 528. The patient may begin therapy the following day (i.e., after midnight), at which point the daily limit will reset.

In some embodiments, the amount of neurostimulation provided by the neurostimulation system 500 per week is limited. While in the idle state in step 212, if the calendar limit has been exceeded, the controller 520 prevents the patient from starting a treatment session and displays a "calendar limit reached" message on the display 528. For example, the neurostimulation system 500 can be configured to stop delivering neurostimulation to the patient 1-14 weeks after receiving the neurostimulation system 500 from the physician. To reactivate the neurostimulation system 500 after the calendar limit has expired, the patient needs to visit a physician or clinician. In some embodiments, a "calendar limit about to expire" message is displayed on the display 528 to warn the patient that the calendar limit (e.g., two weeks) is about to expire. The "calendar limit about to expire" message facilitates the patient to schedule an appointment with their physician before the calendar limit expires.

In some embodiments, the mouthpiece 540 may wear out over time and require replacement. For example, the patient biting the mouthpiece 540 during each treatment session may gradually cause the surface of the mouthpiece to wear out. This wear may lead to failure of the mouthpiece 540. Multiple mouthpieces 540 may be tested over multiple treatment sessions and inspected for wear at the end of each treatment session to calculate a mean time between failures (MTBF). Once determined, the MTBF may be programmed into the controller 520. During the idle state in step 212, if the MTBF has expired, the controller 520 prevents the patient from starting a treatment session and displays a "Mouthpiece Expired" message on the display 528. In some embodiments, the display 528 displays a message to warn the patient that the mouthpiece is about to expire. For example, the message displayed on the display 528 may be "Mouthpiece expires in 14 days."

In some embodiments, if the mouthpiece 540 cannot be authenticated, the display 528 may display an "authentication error" message, such as that depicted in Figures 9A and 9B. In some embodiments, the neurostimulation system 500 may track the patient's activity level. For example, the neurostimulation system 500 may include an accelerometer that detects the patient's activity level (e.g., stationary, walking, or running). In some embodiments, the activity level may be recorded and stored on an external computer for analysis. For example, the recorded activity level data may be analyzed by a physician to determine the effectiveness of a prescribed treatment plan. In some embodiments, when treatment begins at step 228, the intensity level of the neurostimulation system 500 may be set to 75% of the last intensity level used. In some embodiments, data including timestamps, intensity levels, data received from the accelerometer, and data received from the tongue sensing circuitry may be recorded and stored on an external computer or mobile device for analysis.

In some embodiments, port 516 is used to charge the neurostimulation system 500. For example, when port 516 is connected to a charging power source, the neurostimulation system 500 enters a charging state. In the charging state, the display 528 displays a "Charging" message. In addition, in the charging state, the LED can indicate the remaining battery power. For example, if the battery power is insufficient to complete at least one NIMM therapy session, the LED can emit a flashing red light. If the remaining battery power is sufficient to complete at least one NIMM therapy session, the LED can emit a flashing green light. When the battery charging is complete, the LED can emit a steady green light (e.g., a non-flashing green light). When the neurostimulation system 500 is in the charging state, the patient cannot start a NIMM therapy session. When the port is disconnected in the charging state, the neurostimulation system 500 enters an idle state (step 212).

In some embodiments, an LED included in the power button 521 can indicate the remaining battery charge. For example, if the remaining battery charge is sufficient to complete two or more NIMM therapy sessions, the LED can illuminate green. If the remaining battery charge is sufficient to complete one NIMM therapy session, the LED can illuminate yellow. If the remaining battery charge is insufficient to complete one NIMM therapy session, the LED can illuminate red. In some embodiments, the controller 520 includes an LED, an audio alarm, or a vibration indicator that can provide visual indications to the patient. For example, the LED, audio alarm, and vibration indicator can indicate to the patient if electrical nerve stimulation is being delivered to the mouthpiece 540, if electrical nerve stimulation delivered to the mouthpiece 540 has been disabled or canceled, or if a NIMM therapy session has ended. This indication can include a steady or flashing light emitted by the LED or a predetermined sound, such as a ringing, chirping, or buzzing sound, emitted by the audio alarm. The vibration indicator can provide tactile or other vibration feedback to the patient. In some embodiments, the audio and/or vibration indicator includes a piezoelectric element or an electromagnetic buzzer that vibrates and provides a mechanical indication to the patient. In some embodiments, an LED and/or audio alarm indicates when a NINN therapy session is 50% complete. In some embodiments, the LED and/or audio alarm indicates when any button on the controller 520 is pressed by the patient. In some embodiments, the LED and/or audio alarm indicates the intensity level of electrical nerve stimulation. In some embodiments, the LED and/or audio alarm indicates the remaining time in the NINN therapy session. In some embodiments, the LED and/or audio alarm indicates the remaining stimulation time for the day (e.g., before the daily limit is reached). In some embodiments, the LED and/or audio alarm indicates the remaining stimulation time for the current calendar day (e.g., before the calendar limit is reached). In some embodiments, pressing the Start/Stop/Pause button while delivering neurostimulation pauses the therapy session (step 233), and the neurostimulation system 500 stops providing non-invasive neurostimulation to the patient's mouth.

Figures 6A and 6B illustrate a noninvasive neurostimulation system 600. The noninvasive neurostimulation system 600 includes a headband 618, a controller 620, buttons 622, a display 628, a mouthpiece 640, an electrode array 642, and a cable 624. The controller 620 is in electrical communication with the mouthpiece 640 and the electrode array 642 via the cable 624. During operation, the patient wears the headband 618 over their ears and inserts the mouthpiece 640 into their mouth. The operation of the noninvasive neurostimulation system 600 is similar to that described above with reference to Figures 5A and 5B, where like referenced elements have the same functions (e.g., the controller 620 has the same functions as the controller 520, etc.). In some embodiments, the headband 618 secures the mouthpiece 640 within the patient's mouth during a NIMN therapy session. In some embodiments, the headband 618 secures the mouthpiece 640 within the patient's mouth even when the patient is horizontal or upside down.

Figures 7A and 7B illustrate a noninvasive neurostimulation system 700. Noninvasive neurostimulation system 700 includes a headband 718, a controller 720, an intensity setting wheel 722, a mouthpiece 740, an electrode array 742, and a cable 724. Controller 720 is in electrical communication with mouthpiece 740 and electrode array 742 via cable 724. During operation, a patient wears headband 718 around the upper circumference of their head and inserts mouthpiece 740 into their mouth. The patient can increase the intensity of the electrical signal delivered to mouthpiece 740 by rotating the intensity setting wheel clockwise. The patient can decrease the intensity of the electrical signal delivered to mouthpiece 740 by rotating the intensity setting wheel counterclockwise. The operation of noninvasive neurostimulation system 700 is otherwise similar to the operation described above with reference to Figures 5A and 5B, where like referenced elements have the same functions (e.g., controller 720 has the same functions as controller 520, etc.). In some embodiments, the headband 718 is configured to allow the patient to wear his/her glasses during a NITM therapy session.

8A and 8B illustrate a noninvasive neurostimulation system 800. The noninvasive neurostimulation system 800 includes a controller 820, a mouthpiece 840, a button 822, a display screen 828, and an indicator light 832. The controller 820 and mouthpiece 840 are integrated into a single package. The controller 820 is in electrical communication with the mouthpiece 840 and the electrode array 842. During operation, the patient inserts the mouthpiece 840 into his/her mouth, and the rigidly connected controller 820 rests outside the patient's oral cavity. The operation of the noninvasive neurostimulation system 800 is otherwise similar to that described above with reference to FIG5A and 5B, where similarly referenced elements have the same functions (e.g., the controller 820 has the same functions as the controller 520, etc.). In some embodiments, the controller 820 is in mechanical contact with the patient's jaw and is configured to mechanically secure the mouthpiece 840 during a NINM therapy session. In some embodiments, the display screen 828 is not included in the noninvasive neurostimulation system 800. In some embodiments, the display screen 828 is replaced by an auditory indicator that provides auditory messages to the patient. In some embodiments, the controller 820 and mouthpiece 840 are integral and connected by a connection point between the mouthpiece 840 and the controller 820. In some embodiments, the mouthpiece 840 is removably connected to the controller 820 and can be replaced at predetermined usage intervals or due to wear.

FIG9A illustrates a method 900 for operating the noninvasive neurostimulation device shown in FIG5-8. First, the patient connects the mouthpiece to a controller or mobile device (step 904). This connection can be wired or wireless. A processor within the controller or mobile device generates a numerical sequence and transmits the generated sequence to the mouthpiece (step 908). The numerical sequence generated in step 908 can be a random sequence, which can be generated using a software pseudo-random number generator or a hardware random number generator. The processor within the mouthpiece generates a first hash code based on the received numerical sequence and a secret key shared between the mouthpiece and the controller (step 912). The first hash code can be generated using an HMAC (Keyed-Hash Message Authentication Code) algorithm. In some embodiments, the first hash code can be generated using the SHA-256 algorithm. The mouthpiece then transmits the first hash code to the controller (step 916). The processor within the controller generates a second hash code based on the shared secret key and the numerical sequence (step 920), and then compares the first hash code with the second hash code (step 924). The digital sequence generated in step 920 can be a random sequence, generated by a software pseudo-random number generator or a hardware random number generator. In some embodiments, the second hash code can be generated according to the SHA-256 algorithm. If the first hash code matches the second hash code, electrical communication between the controller and the mouthpiece is enabled (step 928). The patient then inserts the mouthpiece into their mouth so that the mouthpiece contacts the patient's oral cavity (step 932). The controller can then transmit the electrical nerve stimulation signal to the patient's oral cavity via the mouthpiece (step 936).

FIG9B illustrates another method 939 for operating the noninvasive neurostimulation device shown in FIG5-8 according to an embodiment of the present invention. First, the patient connects the mouthpiece to a controller or mobile device (step 940). This connection can be wired or wireless. During manufacturing, a first hash code is generated based on the unique serial number and a secret key shared between the mouthpiece and the controller (step 944). The first hash code can be generated using an HMAC (keyed-hash message authentication code) algorithm. In some embodiments, the first hash code can be generated using the SHA-256 algorithm. The first hash code and the unique serial number can be stored in a memory within the mouthpiece. The mouthpiece then transmits the first hash code and the unique serial number to the controller (step 948). The controller generates a second hash code based on the received unique serial number and the shared secret key (step 952). The second hash code can be generated using an HMAC (keyed-hash message authentication code) algorithm. In some embodiments, the second hash code can be generated using the SHA-256 algorithm. The controller then compares the second hash code with the first hash code. The controller allows continued electrical communication with the mouthpiece only if the second hash code matches the first hash code (step 956). The patient then inserts the mouthpiece into his/her mouth so that the mouthpiece contacts the patient's oral cavity (step 960 ). The controller can then transmit the electrical nerve stimulation signal to the patient's oral cavity via the mouthpiece (step 964 ).

FIG10A-10D illustrate a controller 1020 configured to generally conform to the shoulder and/or neck region of the patient shown in FIG1 . Controller 1020 has a length L (e.g., in some embodiments, length L may be in the range of 180 to 250 mm), includes a front portion 1060, a rear portion 1064, and two arms 1062 separating front portion 1060 from rear portion 1064. Controller 1020 also includes a mouthpiece port 1016, an intensity increase button 1008, an intensity decrease button 1012, a power button 1021, an information button 1024, a start/stop button 1004, and a display 1028. Rear portion 1064 has a first radius of curvature 1034 within a transverse plane of the patient and a second radius of curvature 1036 within a transverse plane of the patient. For example, in some embodiments, first radius of curvature 1034 may be in the range of 20-50 mm, and second radius of curvature 1036 may be in the range of 15-35 mm. The two arms 1062 are spaced apart by a distance W1 and have a first radius of curvature 1030 in the patient's sagittal plane and a second radius of curvature 1032 in the patient's transverse plane. For example, in some embodiments, the first radius of curvature 1030 may be in the range of 100-400 mm, the second radius of curvature 1032 may be in the range of 300-500 mm, and the distance W1 may be in the range of 90-150 mm. Each arm 1062 has a central portion 1050 configured to contact the patient's neck and/or shoulder. The front portion 1060 has an opening with a width W2 and may have a first mass m1 and be located a first distance d1 from the central portion 1050 of the arm 1062. The rear portion 1064 has a second mass m2 and is located a second distance d2 from the central portion 1050 of the arm 1062. In some embodiments, m1 may have a value in the range of 15-45 grams, and m2 may have a value in the range of 50-80 grams. In some embodiments, m1 can be approximately 25 grams and m2 can be approximately 60 grams. The distances d1, d2 and masses m1, m2 can be selected so that the controller fits or substantially fits the patient's shoulder and/or neck as shown in FIG1 . In some embodiments, the product of d1 and m1 is greater than the product of d2 and m2. In some embodiments, m1 and m2 are approximately equal and d1 is greater than d2, such that m1*di>m2*d2. In some embodiments, m1 is less than m2 and d1 is greater than d2, such that m1*di>m2*d2. In some embodiments, m1 is greater than m2 and d1 is greater than d2, such that m1*d1>m2*d2. In some embodiments, d1 and d2 are approximately equal and m1 is greater than m2, such that m1*d1>m2*d2. In some embodiments, d1 and d2 are approximately equal and m1 is greater than m2, such that m1*d1>m2*d2. In some embodiments, d1 is less than d2 and m1 is greater than m2, such that m1*d1>m2*d2. In some embodiments, the first mass is in the range of 15-35 g, the second mass is in the range of 60-65 g, the first distance is in the range of 110-140 mm, and the second distance is in the range of 30-70 mm. In some embodiments, the ratio of the second mass to the first mass is approximately 2.5 and the ratio of the first distance to the second distance is approximately 3. The operation of the controller 1020 is similar to the controller 520 described herein.

The terms used herein are for describing the purpose of specific embodiments, rather than being intended to limit the present invention. It should be understood that although the terms first, second, third, etc. are used to describe various elements, components, regions, layers and/or parts in this article, these elements, components, regions, layers and/or parts should not be limited to these terms. These terms are only used to distinguish another element, component, region, layer or part from an element, component, region, layer or part. Therefore, the first element, component, region, layer or part discussed below can be referred to as the second element, component, region, layer or part, without departing from the teaching of the application.

Although the inventive concept has been specifically shown and described above in conjunction with exemplary embodiments, it will be understood by those skilled in the art that various changes in form and details may be made without departing from the spirit and scope of the inventive concept as described and defined by the claims.

Claims (53)

1. A system for providing non-invasive neurorehabilitation treatment to a patient, comprising: A mouthpiece comprising: an elongated housing having a front portion and a rear portion, the elongated housing having a non-planar outer top surface; a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue; a control circuit mounted on top of the elongated housing and configured to control the electrical signals delivered to the electrodes; a cable having a first end connected to the front of the elongated housing and a second end having a connector connected to a controller, the cable delivering current to the electrodes via the control circuit; and A controller comprising: an elongated U-shaped member having a first arm and a second arm separating a rear portion from a front portion, the front portion of the elongated U-shaped member being a first distance from one of the arms and having a first mass, and the rear portion of the elongated U-shaped member being a second distance from the other of the arms and having a second mass, and the product of the first distance and the first mass being greater than the product of the second distance and the second mass; an electrical receptacle located on the front of the elongated U-shaped member and connected to the electrical cable; and A microcontroller is located within the elongated U-shaped member, the microcontroller being configured to send electrical control signals to the mouthpiece, the electrical control signals being used to determine the amplitude and duration of the electrical signal delivered to the patient's tongue. 2. The system of claim 1 , wherein the width of the elongated U-shaped element corresponds to the 60th percentile of adult male neck width. 3. The system of claim 1, wherein the elongated U-shaped element has a length of 200 mm. 4. The system of claim 1, wherein the elongated U-shaped element has a width of 120 mm. 5. The system of claim 1 , wherein the front portion comprises a first portion having a first width of 35 mm and a second portion having a second width of 35 mm, the first portion being connected to the first arm and the second portion being connected to the second arm. 6. The system of claim 1, wherein the first mass is greater than the second mass. 7. The system of claim 1, wherein the first mass is smaller than the second mass. 8. The system of claim 1, wherein the first and second distances are dependent upon a portion of the arm configured to contact the patient's shoulder. 9. The system of claim 1, wherein the radius of curvature of the arm in the patient's sagittal plane is in the range of 20-30 centimeters to allow the controller to fit around the patient's shoulder. 10. The system of claim 1, wherein the width of the elongated U-shaped member is between 60% and 80% of the length of the elongated U-shaped member. 11. The system of claim 1 , wherein the width of the elongated U-shaped element is 60% of the length of the elongated U-shaped element. 12. The system of claim 1, wherein the inner contour of the posterior portion has a radius of curvature in a transverse plane of the patient in the range of 20-60 mm. 13. The system of claim 1, wherein the inner contour of the posterior portion has a radius of curvature of 40 mm in a transverse plane of the patient. 14. The system of claim 1, wherein the outer contour of the posterior portion has a radius of curvature in a transverse plane of the patient in the range of 10-40 mm. 15. The system of claim 1, wherein the outer contour of the posterior portion has a radius of curvature of 25 mm in a transverse plane of the patient. 16. The system of claim 1, wherein the first and second arms have a profile having a radius of curvature in a transverse plane of the patient in the range of 330-430 mm. 17. The system of claim 1, wherein the first and second arms have a profile having a radius of curvature of 380 mm in a transverse plane of the patient. 18. The system of claim 1, wherein the front portion includes an opening 30-60 mm wide. 19. The system of claim 1, wherein the front portion includes an opening that is 45 mm wide. 20. The system of claim 1, further comprising an accelerometer for measuring the patient's activity level. 21. The system of claim 1, further comprising a data logger for recording information related to the patient's activity level. 22. The system of claim 1, further comprising tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at a bottom portion of the mouthpiece. 23. The system of claim 1, further comprising a clock for determining a total usage time of the mouthpiece. 24. The system of claim 1, further comprising a battery for providing electrical current to the mouthpiece. 25. The system of claim 24, further comprising a light indicator to indicate the charge level of the battery. 26. The system of claim 1, further comprising an audio indicator for alerting the patient when the remaining battery charge is insufficient to complete a treatment session. 27. A system for providing non-invasive neurorehabilitation treatment to a patient, comprising: A mouthpiece comprising: an elongated housing having a front portion and a rear portion, the elongated housing having a non-planar outer top surface; a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous localized electrical stimulation to the patient's tongue; a control circuit mounted on top of the elongated housing and configured to control the electrical signals delivered to the electrodes; and a first communication module for transmitting current to the electrodes via the control circuit; and A controller comprising: an elongated U-shaped member having a first arm and a second arm separating a rear portion from a front portion, the front portion of the elongated U-shaped member being a first distance from one of the arms and having a first mass, and the rear portion of the elongated U-shaped member being a second distance from the other of the arms and having a second mass, and the product of the first distance and the first mass being greater than the product of the second distance and the second mass; a second communication module disposed within the housing and coupled to and in communication with the first communication module; and A microcontroller is located within the housing and is configured to exchange electrical signals with the mouthpiece for determining the amplitude and duration of electrical stimulation energy pulses delivered to the patient's tongue. 28. The system of claim 27, further comprising an accelerometer for measuring the patient's activity level. 29. The system of claim 27, further comprising a data logger for recording information related to the patient's activity level. 30. The system of claim 27, further comprising tongue sensing circuitry for detecting whether the patient's tongue is in contact with a plurality of electrodes located at a base of the mouthpiece. 31. The system of claim 27, further comprising a real time clock for determining a total usage time of the mouthpiece. 32. The system of claim 27, further comprising a battery for providing electrical current to the mouthpiece. 33. The system of claim 32, further comprising a light indicator that indicates the charge level of the battery. 34. The system of claim 27, further comprising an audio alarm for alerting the patient when the remaining battery charge is insufficient to complete a course of treatment. 35. The system of claim 27, wherein the width of the elongated U-shaped member corresponds to the 60th percentile of adult male neck width. 36. The system of claim 27, wherein the elongated U-shaped element has a length of 200 mm. 37. The system of claim 27, wherein the elongated U-shaped member has a width of 120 mm. 38. The system of claim 27, wherein the front portion comprises a first portion having a first width of 35 mm and a second portion having a second width of 35 mm, the first portion being connected to the first arm and the second portion being connected to the second arm. 39. The system of claim 27, wherein the first mass is greater than the second mass. 40. The system of claim 27, wherein the first mass is smaller than the second mass. 41. The system of claim 27, wherein the first and second distances are dependent upon an arm configured to contact a shoulder of the patient. 42. The system of claim 27, wherein the first and second distances are dependent upon a portion of the arm configured to contact the patient's shoulder. 43. The system of claim 27, wherein the radius of curvature of the arm in the patient's sagittal plane is in the range of 20-30 centimeters to allow the controller to fit around the patient's shoulder. 44. The system of claim 27, wherein the width of the elongated U-shaped member is between 60% and 80% of the length of the elongated U-shaped member. 45. The system of claim 27, wherein the width of the elongated U-shaped member is 60% of the length of the elongated U-shaped member. 46. The system of claim 27, wherein the inner contour of the posterior portion has a radius of curvature in a transverse plane of the patient in the range of 20-60 mm. 47. The system of claim 27, wherein the inner contour of the posterior portion has a radius of curvature of 40 mm in a transverse plane of the patient. 48. The system of claim 27, wherein the outer contour of the posterior portion has a radius of curvature in a transverse plane of the patient in the range of 10-40 mm. 49. The system of claim 27, wherein the outer contour of the posterior portion has a radius of curvature of 25 mm in a transverse plane of the patient. 50. The system of claim 27, wherein the first and second arms have a profile having a radius of curvature in a transverse plane of the patient in the range of 330-430 mm. 51. The system of claim 27, wherein the first and second arms have a profile having a radius of curvature of 380 mm in a transverse plane of the patient. 52. The system of claim 27, wherein the front portion includes an opening having a width of 30-60 mm. 53. The system of claim 27, wherein the front portion includes an opening that is 45 mm wide.