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WO2025101969A1 - Stratégies pour des effets améliorés de stimulation de la moelle épinière sur la récupération motrice - Google Patents

Stratégies pour des effets améliorés de stimulation de la moelle épinière sur la récupération motrice Download PDF

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Publication number
WO2025101969A1
WO2025101969A1 PCT/US2024/055225 US2024055225W WO2025101969A1 WO 2025101969 A1 WO2025101969 A1 WO 2025101969A1 US 2024055225 W US2024055225 W US 2024055225W WO 2025101969 A1 WO2025101969 A1 WO 2025101969A1
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Prior art keywords
movement
limb
stimulation
muscles
stimulating
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Inventor
Marc Philip POWELL
Nikhil VERMA
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Reach Neuro Inc
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Reach Neuro Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1124—Determining motor skills
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36062—Spinal stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A61N1/36139—Control systems using physiological parameters with automatic adjustment

Definitions

  • the present disclosure generally relates to a spinal cord stimulation device, and more particularly, a spinal cord stimulation device and sensor for detecting movement of a limb and providing stimulation to the spinal cord to enhance movement of that limb.
  • Conditions such as stroke may leave an individual without the use of one or more limbs.
  • One of the oldest device-based approaches to stroke treatment is functional electrical stimulation, which bypasses the corticospinal tract and stimulates individual muscles directly.
  • Spinal cord stimulation has been used to treat a variety of disorders including pain management.
  • Spinal cord stimulation for pain management involves manually searching for stimulation parameters that yield analgesic effects.
  • the disclosure provides a method of improving movement of a limb or a portion thereof.
  • the method comprises detecting a movement intention of at least one muscle in a limb with a sensor. Electrically stimulating at least one area proximate the spine with at least one stimulating element.
  • the electrical stimulation causes the limb or any portion thereof to move in accordance with the movement intention.
  • the at least one stimulating element is a part of an array of stimulating elements.
  • the at least one stimulating element is positioned such that stimulation of the area proximate the spine will cause the muscles of the limb to affect a movement of the limb.
  • the electrical stimulus is modulated so that muscles affecting that movement of the limb are stimulated and muscles not associated with that movement are not simultaneously stimulated.
  • the disclosure provides a system for improving the movement of a limb.
  • the system comprises a sensor, an array of stimulating elements, a processor and a controller.
  • the sensor detects movement intentions of joints in a limb.
  • the array of stimulating elements is positioned proximate the spine.
  • the array of stimulating elements comprising individual elements positioned to electrically stimulate regions of the spinal cord which correspond to discrete muscles in the limb.
  • the controller directs the stimulation from the stimulator applied through the stimulating elements.
  • the processor determines the timing and duration of the stimulation provided by the stimulating elements.
  • the processor determines which stimulating element or elements to stimulate, and the controller stimulates the stimulating element or elements to activate the muscle in the limb in accordance with the movement intention.
  • the electrical stimulus is modulated so that the muscles affecting movement of the limb are activated and the muscles antagonistic to that movement or not associated with that movement are not simultaneously activated.
  • Figure 1 is a depiction of a spinal cord stimulation system.
  • the system includes sensors to monitor movement and movement intention of the arm to which they are attached.
  • the spinal leads or electrodes are implanted in the epidural space of the cervical spinal cord.
  • the system also includes a stimulator, in the depicted figure it is an external stimulator.
  • Figures 2A-2C are depictions of the implanted electrodes with a map of their location relative to spine segments and the muscles which are affected by the electrodes.
  • Figure 2A depicts stimulation of the 2R electrode which primarily affects the bicep muscle.
  • Figure 2B depicts stimulation of the 5C electrode.
  • Figure 2C depicts stimulation of the 8C electrode.
  • Figure 3 is a diagram depicting movement of an arm.
  • the arm receives phasic stimulation, that is stimulation at the 1R and 1C electrodes for flexion of the elbow, and stimulation of the 5C electrode for extension of the elbow.
  • Figure 4 depicts a movement map depicting the path a hand follows as it moves between a first point and a second point. There is a map for multiple different stimulation conditions.
  • Figures 5A-5B are graphs depicting the max initial elbow speed of two patients under multiple stimulation conditions.
  • Figures 6A and 6B are depictions of the movement kinematics of two subjects, under multiple stimulation conditions.
  • Figures 7A and 7B are graphs depicting muscle activation patterns.
  • Figures 8A and 8B are graphs depicting the muscle activity.
  • Figures 9A-9C depict proportional stimulation.
  • Figures 11B and 11C depict patient responses to
  • Movement intention is the brain process of deciding what and when to move. Movement intention can be detected using a number of different biomarkers including but not limited to neural action potentials in the brain, cerebellum, spinal cord, or peripheral nerves; muscle activity of the muscle associated with the intended movement; initialization of the movement or a part of the movement as measured by kinematic sensors; etc.
  • tonic stimulation means delivering a constant stream of electrical pulses.
  • phrasesic stimulation means delivering electrical pulses at different periods. Phasic stimulation delivers electrical pulses when needed and stops the pulses when not needed.
  • limb means a jointed muscled appendage.
  • the distal most portion of a limb is known as the extremity.
  • the upper limbs are known as the shoulders and arms and the lower limbs are known as the legs.
  • the human arms have relatively great ranges of motion and are highly adapted for grasping and for carrying objects.
  • the extremity of each arm known as the hand, has five opposable digits known as fingers (made up of metacarpal and metatarsal bones for hands and feet respectively) and specializes in intrinsic fine motor skills for precise manipulation of objects.
  • the human legs and their extremities the feet are specialized for bipedal locomotion.
  • portional stimulation means changing the stimulation to a muscle or a group of muscles over the course of a movement.
  • the change to the stimulation may be in the wavelength, the frequency, or other aspects of the stimulation.
  • Conditions such as stroke may leave an individual without the use of one or more limbs or of portions of those limbs.
  • One of the oldest device-based approaches for stroke treatment is functional electrical stimulation, which bypasses the corticospinal tract and stimulates individual muscles directly.
  • the functional electrical stimulation forces involuntary activation of muscles, which also tends to cause rapid fatigue.
  • the electrical stimulation through the skin tends to be uncomfortable, and coordinating the activation of synergistic muscle groups has proved difficult.
  • functional electrical stimulation assisted rehabilitation there has been little evidence demonstrating the benefits of functional electrical stimulation. Additionally, neither of the foregoing approaches restore direct brain control over movement and/or reduce motor impairment, which may be provided by the systems and methods described herein.
  • Spinal cord stimulation has been used to treat a variety of disorders including pain management.
  • Spinal cord stimulation for pain management involves manually searching for stimulation parameters that yield analgesic effects.
  • spinal cord stimulation may be applied to recover the usage of limbs.
  • the application of spinal cord stimulation to regain at least partial usage of limbs is associated with a number of challenges; one or more of which are at least partially overcome by the description here.
  • a first challenge is that, while pain treatment is binary (e.g., better or worse).
  • pain treatment is binary (e.g., better or worse).
  • spinal cord stimulation to promote recovery of limb function is more complex.
  • spinal cord stimulation to promote recovery of limb function may require the identification of multiple sets of electrodes and stimulation parameters to achieve targeted treatment of deficits across multiple muscles, which may occasionally be referred to herein as "kinematic parameters,” “kinematic parameter set,” or similar.
  • a second challenge with using spinal cord stimulation to treat motor dysfunction is the heterogeneity of the population being treated.
  • each patient i.e., stroke victim
  • each patient may have a unique set of deficits.
  • each patient may have a slightly different physiology (e.g., muscle strength, nerve condition, epidural space, etc.) and/or the implantation of the electrode(s) may vary (e.g., from patient-to-patient and/or in relative alignment vertebrae-to-vertebrae within a patient).
  • a third challenge is identifying kinematic parameters to ensure balanced facilitation of all targeted muscle groups, since stimulation may affect opposing muscles (e.g., bicep and triceps).
  • a fourth challenge is identifying the most effective form of stimulation for each patient.
  • Tonic stimulation is generally most helpful for stroke patients who have more remaining connection between the brain and the spine, while tonic stimulation would not be as helpful for patients with more severe deficit.
  • Phasic stimulation is generally most helpful for stroke patients with little remaining connection between the brain and the spine.
  • a spinal cord stimulation system may be used to substitute or assist many of the motor functions associated with the brain.
  • SCS Spinal cord stimulation
  • SCS devices may be used to provide stimulation to the spinal cord or associated structures such as the dorsal roots and ventral roots for treatment of neurological diseases and disorders such as chronic pain and/or stroke, Spinal Cord Injury (SCI), Spinal Muscular Atrophy (SMA), Traumatic Brain Injury (TBI), Cerebral Palsy (CP), Amyotrophic Lateral Sclerosis (ALS), and/or Duchenne Motor Disorder.
  • SCI Spinal Cord Injury
  • SMA Spinal Muscular Atrophy
  • TBI Traumatic Brain Injury
  • CP Cerebral Palsy
  • ALS Amyotrophic Lateral Sclerosis
  • Duchenne Motor Disorder may provide stimulation to the spinal cord to treat impairment of a limb due to a neurological disease or disorder.
  • Cortical control of muscle activation begins in the primary motor cortex of the brain. Upper motor neurons generate electrical signals for voluntary muscle movement. The electrical signals travel down the spinal cord primarily through the corticospinal tract. The electrical signal is then transferred to the lower motor neurons and exits the spinal cord. The signal continues through peripheral nerves the neuromuscular junction, where the motor neuron interfaces with muscles. ( Figure 1).
  • Stroke may damage the corticospinal tract (CST) or other neural pathways causing motor impairments that are often permanent.
  • CST corticospinal tract
  • Tonic epidural stimulation of the cervical spinal cord has been shown to improve strength and dexterity in the arm and hand of people with chronic hemiparesis post-stroke. While tonic stimulation enhances recruitment of targeted muscles, manual tasks of daily life involve coordinated and sequential activation of muscles throughout the limb.
  • Studies of SCS in animals have shown that phase-specific patterns of SCS were sometimes required to enable compound movements comprising reaching, grasping, and pulling phases.
  • Patients who have suffered a stroke can be categorized based on the extent of their injury. Mild injury means that some electrical signals are making it through the corticospinal tract. Moderate injury means that few electrical signals are making through the corticospinal tract. Severe injury means that little to no electrical signals are making it through the corticospinal tract.
  • the methods for facilitating limb functions in a person include a system for sensing movement and stimulating or enhancing muscle movement.
  • the system includes sensors to sense movement and stimulating elements to stimulate the neurons in the spinal cord.
  • the stimulating elements may include electrodes that include linear spinal leads. These leads are implanted in the epidural space of the cervical spine. ( Figure 1).
  • the spinal leads connect to a stimulator.
  • the stimulator is an external stimulator.
  • the stimulator attaches to the individual's body.
  • the stimulating elements may include electrodes that include paddle spinal leads.
  • the stimulator is implanted in the individual's body.
  • the number of electrodes in the array of electrodes may vary depending on the implementation.
  • the number of electrodes may vary based on the targeted set of limbs (e.g., upper, lower, or both) in the use case, the number of array segments and degree of overlap, the inter-electrode spacing in a linear array of electrodes, etc.
  • the electrodes comprising the array of electrodes are implanted in specified locations relative to the patient's anatomy. For example, a first electrode in the array of electrodes is implanted proximal to the dorsal root entry zone of spinal segment C3, a second electrode is implanted proximal to the dorsal root entry zone of spinal segment C43, and so forth to cover C3-T1 portion of the cervical spinal cord.
  • the electrodes comprising the array of electrodes have a fixed location relative to one another (e.g., in a linear array) and the array of electrodes is implanted to span a relevant portion of the spine.
  • an example of an electrode array which is illustrated as comprising two linear array segments in Figure 1, is illustrated in context (i.e., as implanted in the patient) in accordance with some implementations.
  • a first linear electrode array segment is implanted in the epidural space rostral relative to a second linear electrode array segment, labeled as which is implanted in the epidural space caudal relative to the first linear electrode array, hence the "R" and "C” labels.
  • the electrode array (comprising electrodes R 124R and 124 C) span a portion of the spinal cord relevant to limb mobility, which in the illustrated example includes C3-T1 of the cervical spinal cord and associated with upper-limb mobility.
  • the electrode array comprises sixteen (16) electrodes, as each electrode array segment 124R and 124C includes eight (8) electrodes.
  • the eight (8) electrodes of electrode R 124R are represented as 1R-8R
  • eight (8) electrodes of electrode C 124C are represented as 124R and 1C-8C.
  • the electrode arrays illustrated in Figures 1 are merely examples provided for clarity and convenience and that variations are expected and within the scope of this disclosure.
  • the electrode array is illustrated as comprising two linear array segments (i.e., rostral electrode array R and caudal electrode array)
  • the electrode array may comprise more or fewer segments depending on the implementation and/or use case.
  • the degree of overlap between electrode segments and/or the presence of overlap may vary from what is illustrated in Figure 1 and depend on the implementation and/or use case.
  • electrode array segments may be positioned laterally (e.g., right and left of the midline) relative to one another.
  • Figure 1 is illustrated in the context of the cervical spine, which is relevant to a use case involving upper-limb mobility, but other contexts and use cases (e.g., lumbar and/or sacral spine for a lower-limb use case) are within the scope of this disclosure.
  • Figure 1 represents a desired, or target, implantation of the electrode array
  • some degree of variation from Figure 1 in actual instances of implantation and/or from patient-to-patient is to be expected, e.g., based on variation in vertebrae size relative to electrode array size and spacing, positioning of the array(s) during implantation and/or shift post-implantation, etc.
  • the electrode array may be a 2-dimensional array of electrodes such as a paddle electrode.
  • an electrode in the array of electrodes may apply electric stimulation at its location.
  • the electric stimulation applied by an electrode in the array of electrodes is associated with a set of parameters. Examples of parameters include, but are not limited to, a current amplitude, a pulse width, a frequency, etc. of a waveform.
  • the waveform is a biphasic square wave. However, the waveform may vary depending on the implementation. For example, the waveform may be a sine wave, monophasic pulses, triangle wave, etc.
  • at least one electrode in the array is configured to be monopolar where the current delivered through it returns through the case of the stimulator.
  • Either the electrode or the case may be the cathode and the other the anode.
  • one or more electrodes are configured to be bipolar or multipolar in that one or more electrodes acts as a cathode and one or more other electrodes acts as an anode.
  • stimulation is delivered through multiple sets of monopolar or multipolar configurations of electrodes such that stimulation pulses are interleaved in time relative to pulses delivered through other sets of electrodes.
  • each electrode in the electrode array applies either a biphasic and charge-balanced pulse or a monophasic with passive charge balance pulse to ensure no net charge accumulation at the associated electrode.
  • the electric stimulation by a particular electrode (or set of electrodes) in the array and the associated parameters are determined by the stimulator.
  • the stimulator 120 is coupled to the electrode array 124.
  • stimulator 120 which may also be referred to herein as a "neurostimulator,” “neuromodulator, or similar, is configured to provide electrical signals to electrode array 124 to provide electrical stimulation to a desired area.
  • the stimulator 120 selectively activates, deactivates, and controls the parameters applied at one or more electrodes of the electrode array 124.
  • the stimulator 120 is implanted in the patient 112 and powered by a battery (not shown).
  • the stimulator 120 comprises an implanted component and an external component where the external component wirelessly powers the implanted component.
  • the parameters applied by the electrodes are not sufficient or intended to induce involuntary motor function. Rather, the stimulation applied by the electrodes modulates the excitability of the motoneurons (where the motoneurons are part of a motor unit used to elicit muscle activity needed to perform a certain movement) so, e.g., the neurological signals for voluntary movement, which may not be sufficient absent modulation, are sufficient to reach the corresponding muscles and result in muscle behavior generally consistent with the patient's intended movement and/or limb behavior.
  • the one or more parameters are restricted to an associated permissible range.
  • a permissible amplitude range is one or more of a 0-10 mA, 0-25 mA, or a percentage of motor threshold amplitude.
  • the parameters may be restricted to be below a motor threshold, e.g., restricted to a range of 0-20% of motor threshold amplitude or 0-80% of motor threshold amplitude, where the motor threshold amplitude refers to the stimulation amplitude needed to evoke (involuntary) muscle activity as a result of the stimulation itself, as may be the case for kinematic parameters and/or parameters maximizing muscle activation in some implementations.
  • the parameters may be restricted but exceed a motor threshold, e.g., restricted to a range of 0-120% of motor threshold amplitude or 0-180% of motor threshold amplitude, as may be the case for determining the parameters that maximize muscle activation in some implementations .
  • a permissible frequency range is one or more of 0-100 Hz, 0-200 Hz, 0-10 kHz.
  • a permissible range of pulse frequencies may be 0-400 pS or 0-4 mS. It should be understood that the preceding are merely example ranges and other ranges may be used, e.g., a sub-range within the ranges described above.
  • the stimulator 120 is communicatively coupled to the controller to receive a user-selected kinematic model (described below) that the stimulator 120 applies to control the parameters applied at one or more electrodes of the electrode array 124.
  • a wearable sensor 126 is a set of one or more sensors worn by the user 112. Wearable sensors 126 may be included in one or more form factors including, but not limited to, a smartwatch, a smart ring, chest strap, arm strap, sleeve, adhesive elements, an EEG cap, an implanted ECoG electrode array, an implanted intracortical electrode arrayetc.
  • the wearable sensor 126 may include one or more of an EMG sensor, goniometer, brain activity sensor, gyroscope, accelerometer, magnetometer, pedometer, heart rate monitor, thermometer, galvanic skin sensor, breathing monitor, oximeter, barometer, etc.
  • the wearable sensor 126 is communicatively coupled to a neuromodulation determination engine, such as that described in PCT application PCT/US24/53946 the entirety of which is incorporated by reference, to provide wearable sensor data that may be used to train a kinematic model (described further below).
  • a neuromodulation determination engine such as that described in PCT application PCT/US24/53946 the entirety of which is incorporated by reference.
  • wearable sensor data may be used to train a kinematic model (described further below).
  • gyroscope data from a smartwatch may represent a patient's tremor when reaching during training of a kinematic model, and the training of the kinematic model may be trained to reduce such a tremor (or balance tremor reduction with one or more other objectives).
  • heart rate monitor data and/or galvanic skin sensor data may represent exertion by the patient (i.e., an elevated heart rate and/or sweating, respectively), which may be used by the neuromodulation determination engine to train one or more models to take patient exertion into account when training the one or more models.
  • the EMG sensors 128 are sensors that measure muscle response (e.g., in mV). In some implementations, the EMG sensors 128 are communicatively coupled (e.g., via the network 102) to the neuromodulation determination engine.
  • the EMG sensors 128 may be placed on muscles associated with the lower limbs, such as the glutes, hamstring, quadriceps, tibialis anterior, gastrocnemius, soleus and plantaris, etc.
  • the system 100 may include a camera (i.e., a sensor) and motion capture software may be used to evaluate a patient's movement and score the motion (e.g., measure and score how linear a person's reach) which may be communicatively coupled to the neuromodulation determination engine and used to train a model associated with reaching (i.e., an example of a kinematic task) in accordance with some implementations.
  • a camera i.e., a sensor
  • motion capture software may be used to evaluate a patient's movement and score the motion (e.g., measure and score how linear a person's reach) which may be communicatively coupled to the neuromodulation determination engine and used to train a model associated with reaching (i.e., an example of a kinematic task) in accordance with some implementations.
  • the system 100 may include one or more dynamometers (i.e., sensors), which may be used to evaluate grip strength and/or the torque a user can apply at a joint, which may be communicatively coupled (e.g., via the network) to the neuromodulation determination engine and used to train a model associated with open doors and jar (i.e., an example of a kinematic tasks) in accordance with some implementations.
  • dynamometers i.e., sensors
  • the neuromodulation determination engine may be used to train a model associated with open doors and jar (i.e., an example of a kinematic tasks) in accordance with some implementations.
  • controller 130 is illustrated in Figure 1; however, it should be understood that there may be any number of controllers 130.
  • the controller 130 may be used, by a user 112 that is a programmer or clinician during an initial configuration and set-up period and subsequently used, as represented by signal line, by a user 112 that is a patient, e.g., to switch between kinematic models applied by the stimulator 120 based on the task the patient 112 intends to perform.
  • the patient 112 may select a general model as a default, but when the user intends to carry groceries the patient 112 may select an associated model (e.g., which may maximize the user's strength but makes a tradeoff, e.g., may sacrifice range of motion in the patient's elbow).
  • an associated model e.g., which may maximize the user's strength but makes a tradeoff, e.g., may sacrifice range of motion in the patient's elbow.
  • the user 112 is a human user and occasionally referred to based on their role with respect to the system 100, e.g., "patient” or “subject” with regard to user 112 (i.e., the user 112 who has the electrode array 124 and stimulator 120 functionally coupled to his/her nervous system) or “programmer” or “clinician” with regard to user 112.
  • the electric stimulus improves the movement kinematics of the movement of the limb or portion of the limb.
  • the movement kinematics comprise smoothing hand trajectories, increasing maximum initial elbow speed, and reducing reach duration.
  • smoothing hand trajectories comprises decreasing the number of velocity peaks as a hand is moved from a first point to a second point.
  • the number of velocity peaks is decreased by from about 30% to about 60%.
  • the number of velocity peaks is decreased by from about 40% to about 50%.
  • the number of velocity peaks is decreased by about 30, 35, 40, 45, 50, 55, or 60%.
  • the reach duration is reduced by from about 30% to about 50%. In various embodiments, the reach duration is reduced by from about 35% to about 45%. In particular embodiments, the reach duration is reduced by about 30, 35, 40, 45, or 50%. [00060] In certain embodiments, the maximum initial elbow speed is increased by from about 50% to about 80%. In some embodiments, the maximum initial elbow speed is increased by from about 60% to about 70%. In particular embodiments, the maximum initial elbow speed is increased by about 50, 55, 60, 65, 70, 75, or 80%.
  • the parameters applied by the electrodes are a stimulation to lower the activation needed to illicit a movement by the muscles.
  • a tonic or constant low-level stimulation is sufficient to allow the muscles to perform their functions.
  • the tonic stimulation does not lead to movement that is precise enough for the patient to perform the function they are attempting. This may be due to the tonic stimulation stimulating all the muscles. Stimulation of all muscles may lead to muscles competing against one another across joints. This competition may lead to less precise movement or more erratic movement.
  • tonic stimulation will be sufficient for patients with less severe injuries or obstructions, this is due to the brain being able to do some of the motor functions.
  • a phasic approach to the stimulation of the spinal cord to illicit movement stimulates muscles according to the desired movement and enables the muscles engaged in one movement to be stimulated without the muscles engaged in an antagonistic movement being stimulated simultaneously to impede the desired movement.
  • phasic stimulation directs the stimulation to the muscle or group of muscle which is needed to complete a movement, and the stimulation is removed when that movement is completed.
  • the use of phasic stimulation can therefore be thought of as replacing part of the functions associated with the brain.
  • tonic spinal cord stimulation leads to increases in muscle function and increased mobility of stimulated muscles
  • tonic stimulation stimulates all muscles. By stimulating all muscles, both muscles that are agonistic and antagonistic across joints are stimulated. This stimulation of muscles which are agonistic and antagonistic across a joint may lead to less smooth and natural movements, as the muscles compete with one another. Tonic stimulation may suffice for some patients; however, other patients will have better results with phasic stimulation.
  • Phasic stimulation is non continuous stimulation of specific regions of the spinal cord.
  • Figure 3 depicts the interaction of spinal cord stimulation and movement of the arm. Specifically, in this example the movements of flexion and extension are analyzed. Other movements may include abduction and adduction; external rotation and internal rotation; and pronation and supination.
  • the EMG sensors attached to the arm detect the movement intention.
  • the stimulating device stimulates the leads in positions 1R and 1C. This helps the muscles which flex the elbow, which include the biceps, to contract. When the movement has been completed the stimulation is turned off.
  • Movement kinematics may be used to analyze the quality of movements.
  • One aspect of movement kinematics is the smoothness of the movement.
  • the smoothness of the movement may be measured by the number of velocity peaks in the movement.
  • the smoothness of movement is also visible with a map which plots movement of the hand.
  • the movement map as depicted in Figure 4 shows the movement of the hand as it moves from a first point to a second point under different stimulation conditions. With stimulation turned off, the movement map indicates that the hand is moving sporadically and that the muscles are able to initiate large movements but have little control beyond going from one point to another.
  • the path that the hand traces from the first point to the second point is an erratic pathway. Another way of stating this is that the muscles have very little fine motor control.
  • tonic stimulation at 40 Hz there is increased smoothness in the movement from the first point to the second point and back to the first point.
  • the 40Hz condition exhibits increased fine motor control, however there is still sporadic or uncontrolled movement preventing a smooth movement.
  • the pathway is still erratic, though the deviations from the strait line path from the first point to the second point have become tighter.
  • tonic stimulation at 60Hz the movement becomes smoother and tighter as the hand is moved from the first point to the second point and back. There is still some erratic movement, however the erratic movements have become even tighter to the direct line between the first point and the second point.
  • tonic stimulation at 80Hz the movement between the first point and the second point becomes less smooth than when the tonic stimulation is at 60Hz.
  • the smoothness of the movement is improved.
  • phasic stimulation at 40Hz the smoothness of the movement between the first point and the second point is quite smooth, with any sporadic movement tight to the line between the first point and the second point.
  • the smoothness of the movement with phasic stimulation at 40Hz is smoother than any movement when the stimulation is any tonic stimulation.
  • phasic stimulation at 60Hz the smoothness of the movement is further improved with each movement from the first point to the second point tight to the line between the first point and the second point.
  • phasic stimulation at 80Hz the smoothness of the movement is decreased relative to the 60Hz phasic stimulation.
  • the 80Hz movement is smoother than the 40Hz movement.
  • all phasic stimulation results in smoother movement than tonic stimulation.
  • FIGS 5A and 5B depict the maximum initial elbow speed.
  • Figure 6A depicts one patient's maximum initial elbow speed when differing frequencies of stimulation are used to initiate and propagate movement. The maximum initial elbow speed increases with increased stimulation frequency.
  • Figure 6B depicts another patient's maximum initial elbow speed when differing frequencies of stimulation are used to initiate and propagate movement. All frequencies of stimulation increase the max initial elbow speed. The phasic stimulation shows greater increase in the max initial elbow speed as compared to the stimulation of the tonic stimulation.
  • An additional kinematic factor is the reach duration of the movement. A decrease in reach duration indicates an increase in the quality of the movement.
  • Figure 6A shows the movement kinematics of a subject.
  • the movement map shows that tonic and phasic stimulation both lead to smoother movement from the first point to the second point and back.
  • the phasic stimulation leads to even smoother movement between the points.
  • the reach duration decreases in both tonic and phasic stimulation as compared to the stimulation off.
  • the phasic stimulation decreases the duration of movement more than the tonic stimulation does.
  • Another method for measuring smoothness is to measure the number of velocity peaks in the movement from the first point to the second point.
  • the smoothness as measured by the number of velocity peaks decreases with both tonic and phasic stimulation, with the phasic stimulation decreasing the number of velocity peaks more than the tonic stimulation.
  • the maximum initial elbow speed increases with tonic and phasic stimulation.
  • the phasic stimulation leads to greater increase in maximum initial elbow speed.
  • Spinal cord stimulation may also improve muscle activation. Muscle activation may be measured by the EMG sensors attached to the limbs.
  • Figures 7A and 7B are graphs depicting muscle activation patterns. Phasic spinal cord stimulation shows improvement in the muscle activation pattern.
  • a fixed phasic stimulation may stimulate an electrode that activates tricep contraction at 4mA current amplitude, 60 Hz frequency and 200us pulse width and the parameters remain the same for the duration of the elbow extension.
  • the parameters may start at 4mA, 60 Hz, and 200 us, but during the course of the elbow extension, the frequency is increased based on the angle of the elbow, with higher frequencies being used towards the limits of the range of motion to give more support during this part of the extension movement.
  • the parameters may be updated in a continuous manner or a discrete manner.
  • the frequency may be modulated in discrete steps of 10 Hz or continuously, smoothly transitioning between frequencies depending on the elbow angle.
  • the relationship between the movement and the stimulation parameters may be linear or nonlinear.
  • the slope of the change in frequency at the beginning of the movement may be one slope and the slope of the change in frequency at the end of the movement may be a different slope.
  • the relationship between the movement and the stimulation may be defined by a line, an exponential, a sigmoid, parabola, or any arbitrary relationship.
  • Figures 9A-9C depict proportional stimulation.
  • the stimulation of the muscles increases as the movement progresses.
  • Figure 9B depicts a patient response to proportional stimulation.
  • the movement map shows the smoothness of the path the hand takes as it moves from a first point to a second point.
  • the phasic stimulation also be referred to as fixed stimulation, shows a relatively tight distribution of paths as the hand was moved from the first point to the second point and back.
  • the proportional control, or the stimulation changing over the course of the movements showed and even tighter distribution of paths.
  • the efficiency of the path was also improved from the phasic or fixed stimulation to the proportional stimulation as seen in the graphs.
  • Figure 9C depicts a patient response to proportional stimulation.
  • a first embodiment of improving the movement of a limb or a portion thereof comprises detecting a movement intention of at least one muscle in a limb with a sensor. Electrically stimulating at least one area proximate the spine with at least one stimulating element. The electrical stimulation causes the limb or any portion thereof to move in accordance with the movement intention.
  • the at least one stimulating element is a part of an array of stimulating elements.
  • the at least one stimulating element is positioned such that stimulation of the area proximate the spine will cause the muscles of the limb to affect a movement of the limb.
  • the electrical stimulus is modulated so that muscles affecting that movement of the limb are stimulated and muscles not associated with that movement are not simultaneously stimulated.
  • the plurality of stimulating elements of embodiment 1 comprises an array of electrodes.
  • the limb of any of the preceding embodiments is an arm.
  • the electric stimulus of any of the preceding embodiments improves the movement kinematics of the movement of the limb.
  • the movement kinematics of any of the preceding embodiments comprise smoothing hand trajectories, increasing maximum initial elbow speed, and reducing reach duration.
  • the smoothing hand trajectories of any of the preceding embodiments comprises decreasing the number of velocity peaks as a hand is moved from a first point to a second point.
  • the number of velocity peaks of embodiment 8 is decreased by from about 30% to about 60%.
  • the number of velocity peaks of embodiment 9 is decreased by from about 40% to about 50%.
  • the reach duration of embodiment 7 is reduced by from about 30% to about 50%.
  • the reach duration of embodiment 11 is reduced by from about 35% to about 45%.
  • the maximum initial elbow speed of embodiment 7 is increased by from about 50% to about 80%.
  • the maximum initial elbow speed of embodiment 13 is increased by from about 60% to about 70%.
  • the electric stimulus of any of the preceding embodiments reduces the muscle recruitment threshold.
  • the muscle recruitment threshold of embodiment 15 is reduced by from about 25% to about 75%.
  • the muscle recruitment threshold of embodiment 16 is reduced by from about 30% to about 60%.
  • An eighteenth embodiment is a system for improving the movement of a limb, the system comprising: a sensor for detecting a movement intention of muscles in a limb; an array of stimulating elements positioned proximate a spine, the array of stimulating elements having individual elements positioned to electrically stimulate regions of the spinal cord corresponding to discrete muscles in the limb; a controller for directing the stimulating of the stimulator associated with the stimulating elements; and a processor for determining the timing and duration of the stimulating of the stimulating elements; wherein when the sensor detects the movement intention of a muscle in the limb, the processor determines which stimulating element or elements to stimulate, and the controller stimulates the stimulating element or elements to stimulate the muscle in the limb in accordance with the movement intention; and wherein the electrical stimulus is modulated so that the muscles affecting movement of the limb are stimulated and the muscles antagonistic to that movement are not simultaneously stimulated.
  • the plurality of stimulating elements of embodiment 18 comprises an array of electrodes.
  • the array of electrodes of embodiment 19 is implanted in the subcutaneous space of the spinal cord.
  • the modulated electric stimulus of embodiment 20 is a phasic stimulus.
  • the limb of any of the preceding embodiments is an arm.
  • the electric stimulus of any of embodiments 18-22 improves the movement kinematics of the movement of the limb.
  • the movement kinematics of any of embodiments 18-23 comprise smoothing hand trajectories, increasing maximum initial elbow speed, and reducing reach duration.
  • the smoothing hand trajectories of any of embodiments 18-24 comprises decreasing the number of velocity peaks as a hand is moved from a first point to a second point.
  • the number of velocity peaks of embodiment 25 is decreased by from about 30% to about 60%.
  • the number of velocity peaks of embodiment 26 is decreased by from about 40% to about 50%.
  • the reach duration of embodiment 27 is reduced by from about 30% to about 50%.
  • the reach duration of embodiment 28 is reduced by from about 35% to about 45%.
  • the maximum initial elbow speed of embodiment 24 is increased by from about 50% to about 80%.
  • the maximum initial elbow speed of embodiment 30 is increased by from about 60% to about 70%.
  • the electric stimulus of any of embodiments 18-31 reduces the muscle recruitment threshold.
  • the muscle recruitment threshold of embodiment 32 is reduced by from about 25% to about 75%.
  • the muscle recruitment threshold of embodiment 32 is reduced by from about 25% to about 75%.

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Abstract

L'invention concerne un procédé d'amélioration du mouvement d'un membre ou d'une partie d'un membre. Le procédé comprend la détection d'une intention de mouvement d'au moins un muscle d'un membre à l'aide d'un capteur. La stimulation électrique d'au moins une zone proche de la colonne vertébrale par au moins un élément de stimulation. La stimulation électrique amène le membre ou une partie quelconque de celui-ci à bouger conformément à l'intention de mouvement. Le ou les éléments de stimulation font partie d'un réseau d'éléments de stimulation. Le ou les éléments de stimulation sont positionnés de telle sorte que la stimulation de la zone proche de la colonne vertébrale entraîne les muscles du membre à affecter un mouvement du membre. Le stimulus électrique est modulé de telle sorte que les muscles affectant ce mouvement du membre sont activés et les muscles antagonistes ou non associés à ce mouvement ne sont pas activés simultanément.
PCT/US2024/055225 2023-11-10 2024-11-08 Stratégies pour des effets améliorés de stimulation de la moelle épinière sur la récupération motrice Pending WO2025101969A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160175586A1 (en) * 2014-10-10 2016-06-23 Neurorecovery Technologies, Inc. Epidural stimulation for facilitation of locomotion, posture, voluntary movement, and recovery of autonomic, sexual, vasomotor, and cognitive function after neurological injury
US20200147384A1 (en) * 2018-11-13 2020-05-14 Gtx Medical B.V. Sensor in clothing of limbs or footwear
WO2023039207A1 (fr) * 2021-09-09 2023-03-16 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Traitement d'une déficience motrice et/ou d'une déficience de proprioception dues à un trouble ou à une lésion neurologique
WO2023209150A1 (fr) * 2022-04-29 2023-11-02 ECOLE POLYTECHNIQUE FéDéRALE DE LAUSANNE Système de neuromodulation/neurostimulation destiné à atténuer des déficits locomoteurs de la maladie de parkinson, une lésion de la moelle épinière (sci), un accident vasculaire cérébral et/ou d'autres troubles neurologiques

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160175586A1 (en) * 2014-10-10 2016-06-23 Neurorecovery Technologies, Inc. Epidural stimulation for facilitation of locomotion, posture, voluntary movement, and recovery of autonomic, sexual, vasomotor, and cognitive function after neurological injury
US20200147384A1 (en) * 2018-11-13 2020-05-14 Gtx Medical B.V. Sensor in clothing of limbs or footwear
WO2023039207A1 (fr) * 2021-09-09 2023-03-16 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Traitement d'une déficience motrice et/ou d'une déficience de proprioception dues à un trouble ou à une lésion neurologique
WO2023209150A1 (fr) * 2022-04-29 2023-11-02 ECOLE POLYTECHNIQUE FéDéRALE DE LAUSANNE Système de neuromodulation/neurostimulation destiné à atténuer des déficits locomoteurs de la maladie de parkinson, une lésion de la moelle épinière (sci), un accident vasculaire cérébral et/ou d'autres troubles neurologiques

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