RU2580972C2 - Method for neuroelectrostimulation and device therefor - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine and medical equipment. Method includes installing on neck two multi-element electrodes, partial electrodes which function as anodes and cathodes. Supply of current pulses on partial electrodes of first multi-element electrode and partial electrodes of second multi-element electrode is performed so that frequency of switching between partial electrodes of first multi-element electrode is less than frequency of switching between partial electrodes of second multi-element electrode. Method is carried out using a device, in which first multiple-element electrode through first switch, and second multiple-element electrode through second switch connected to processor, connected to current pulse parameters setting unit. Processor is configured to generate frequency switching between partial electrodes of first multi-element electrode is less than frequency of switching between partial electrodes of second multi-element electrode.

EFFECT: invention improves efficiency of electrical stimulation, which is achieved through involvement in a large number of electrical nerve structures located in neck.

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Description

The invention relates to physiotherapy, is intended for the treatment of various diseases in an inpatient or outpatient setting and can be used in neurology, psychiatry, ophthalmology, cardiology and in the treatment of ENT diseases.

Analogues of the proposed method of neurostimulation are various options for drug therapy, psychological correction and methods of stimulation using physical fields.

With drug therapy, adverse reactions are possible, to which various causes lead, determined by therapeutic doses and the peculiarities of the pharmacological action of the drug itself. The prescription of several medications at the same time contributes to this with a poor idea of their interaction with each other. In addition, about 20% of patients are drug resistant or acquire resistance during a long treatment process [1]. According to WHO (2006), 50 out of 1,000 patients hospitalized in a hospital are referred for treatment due to medical complications. In patients treated on an outpatient basis, the number of complications from therapy is (2-3)%, in patients treated in a hospital seriously ill - from 6% to 35%, and an increase in the length of hospitalization, as a result of adverse reactions, is from 1 to 5.5 days. According to other authors, drug complication is observed in (10-20)% of people taking drugs: in the USA, approximately 30% of patients in the hospital give one drug complication during treatment, and one of the 4 deaths is associated with drug complications [2].

Psychological correction is achieved by the active use of psychotherapeutic techniques, pedagogical and neuropsychological corrections. The effect of psychological correction is weakly expressed and quickly disappears in the absence of constant reinforcement. A problematic issue in the implementation of these methods is the need to change the microsocial environment [3].

Neurostimulation using physical fields is a more effective solution, since unlike other methods, in this case, it is possible to organize a direct effect on the problem areas of the nervous system using electric, magnetic and electromagnetic fields.

Widespread in clinical practice are neuroelectrostimulators, in which the structure and dynamic characteristics of the stimulating effect, which are used as low-frequency current pulses, are close to the structure of the control signals of endogenous regulators. The most effective of these stimulants are transcranial electrical stimulator [4], multichannel programmable electrical neurostimulator [5] and non-invasive cranial nerve neuromodulator CN-NiNM [6].

When transcranial electrical stimulation, a low-frequency monopolar sequence of rectangular current pulses with a repetition rate of (77-78) Hz and a duration of (3.5-4.0) ms or a packet of high-frequency impulses with a repetition rate (10-12) kHz of the same duration is used the background of the DC component when the ratio of the current strength of these signals is 1 to 2. The value of the stimulating current can be set within (1.4-1.7) mA. To do this, use electrodes with frontal and mastoid localization. Safe for skin integument, the current density should be no more than (1-2) μA / mm ² . The maximum current value should be no more than 10 mA, the area of the electrodes should be at least 50 cm ² . According to the authors of the method, the method of transcranial electrical stimulation provides direct electrical stimulation of the endorphin mechanisms of the brain, based on the activation of the "protective mechanisms of the brain", the role of which is played by the medially located subcortical structures (nuclei of the hypothalamus, in particular the arcuate nucleus, near-water gray matter of the midbrain, suture nucleus, bridge and brain stem). Due to the activation of these structures, an intensive homeostatic effect occurs and the disturbed functions of systems and organs are normalized, mainly due to the release of endorphins (primarily beta-endorphin) and serotonin. Through this mechanism, anxiolytic and anti-stress effects are realized, as well as, presumably, the effect of nerve cell regeneration. The disadvantage of this method is the reduction in the clinical severity of the therapeutic effect during repeated treatment courses. In addition, it should be noted that in order to affect the subcortical structures, deep penetration of current pulses into the brain is necessary. To do this, it is necessary to increase the amplitude of the current and reduce the area of the electrodes, which will lead to an irritating effect on the skin and to a state of "overexcitation" of the exposed areas of the cerebral cortex [7].

A multi-channel programmable electrical neurostimulator allows you to act on the central and peripheral nervous system by remote long-term stimulation using implantable electrodes. The electroneurostimulator contains a non-implantable part in the form of a pulse transmitter block with pulse-width modulation and an implantable part in the form of a receiver block. The blocks are made with the possibility of magnetic induction coupling. The pulse transmitter contains a tunable high-frequency generator, a telemetry channel receiver, a programmable transmitter microcontroller, a control and programming keyboard, an LCD alphanumeric display, and a power supply. The transmitter is connected to a remote antenna for transmitting high-frequency energy and receiving telemetric information. The receiver unit contains an antenna for receiving high-frequency energy and transmitting telemetric information, a programmable microcontroller for the receiver unit, a digital-to-analog converter, amplifier, multi-channel switch, electrodes and connectors for connecting electrodes to a single-channel switch. The multichannel switch is connected by its working inputs and outputs, forming the contacts of the receiver unit, with the electrodes through the connectors, forming stimulation channels that are switched on individually or by any groups, or all at the same time. The formation of a sequence of biphasic stimulating pulses of any polarity on any pairs of contacts of the receiver unit can be organized in an electroneurostimulator. The frequency of biphasic pulses is from 1 to 250 Hz when one or more channels are switched on at any pairs of contacts of the receiver unit. The duration of the main part of biphasic pulses is discretely controlled from 50 to 750 μs in increments of 50 μs, when one or more channels are switched on on any pairs of contacts of the receiver unit. The duration of the interval between the main and relaxation part of each biphasic pulse is not more than 100 μs, at any frequency in any channel of the device. The electroneurostimulator can be configured to generate a sequence of biphase packs of stimulating pulses of any polarity on any pairs of contacts of the receiver unit. The follow-up period of biphasic bursts of pulses is regulated from 1 to 255 s when any number of channels are switched on on any pairs of contacts of the receiver unit. The duration of the main part of the biphasic pulse train is discretely regulated from 1 to 255 s. The device can be used for electrical stimulation of various areas of the brain and epidural stimulation of the spinal cord. At the same time, a number of neurological diseases are treated: parkinsonism, cerebral palsy, torsion dystonia, spasticity, some forms of epilepsy, consequences of severe traumatic brain injuries, psychopathological syndromes. The disadvantage of this method is the presence of an implantable part, the placement of which in the body requires a neurosurgical operation and its repeated conduct to replace the power source of the implanted part and its repair. In addition, during implantation, internal bleeding, infections, impaired integrity of nerve structures and pathways, loss of function, etc. are possible.

The non-invasive cranial nerve neuromodulator CN-NiNM allows you to act on the central and peripheral nervous system using multi-channel stimulation of the tongue by electric current pulses. The CN-NiNM neuromodulator consists of a block of electrodes located in the oral cavity and a circuit for generating electrical pulses. To generate electrical pulses, a pulse source, a multiplexer and a multi-channel switch are used. The choice of the active electrode in the block of electrodes is carried out by the multiplexer, and a multi-channel switch makes the connection of each of the electrodes of the block of electrodes to either a pulse source or to zero potential. The electric pulse generation circuit provides for the adjustment of the voltage of the pulses from 5 to 15 V, their duration in the range from 5 to 50 μs, the current amplitude from 0.4 to 4 mA and the repetition rate from 10 to 400 Hz. Some methods of using the non-invasive cranial neuromodulator CN-NiNM are described in [8-10]. The disadvantages of the CN-NiNM neuromodulator and methods of its use are: the use of the tongue as a target of stimulation, as this creates certain difficulties with ensuring the sanitary and hygienic conditions of the treatment process, and providing comfortable conditions for the patient with a duration of electrical stimulation of the oral cavity for more than 1-2 minutes .

The closest analogue of neurostimulation of processes in brain tissues is a hardware-software complex for the diagnosis and correction of autonomic dysfunctions, the structural diagram of which is shown in FIG. 1. Here, between the multi-element electrode 2 and the single-element electrode 11, spatially distributed monopolar low-frequency current pulses are formed, the single-element electrode 11 acting as an anode and placed on the neck of the patient 1 in the projection of the cervical ganglia of the sympathetic nervous system or star ganglion on one side of the neck, and partial the electrodes of the multi-electrode 2 act as cathodes and it is located on the other side of the neck; the partial electrodes of the multi-element electrode 2 are isolated from each other and they are alternately connected through the switch 4 to the current source 5; biotropic field parameters (amplitude, frequency and duration of current pulses) are formed in block 7 for setting biotropic parameters of the field of current pulses, the output of this block is connected to processor 6, in which the law of switching current pulses between partial electrodes is formed, and the output signal of processor 6 is fed to the switch 4. Before each treatment procedure, cardiointervalography is performed, systolic and diastolic blood pressure is measured, then the vegetative tone is calculated and in the state of severe sympathicoton AI or moderate sympathicotonia establish the biotropic parameters of the above field (amplitude, frequency and duration of current pulses) that block the activity of the sympathetic nervous system, in which numbness of the earlobe occurs. In the case of autonomic equilibrium, moderate or severe vagotonia during exposure, biotropic field parameters are established that provide stimulation of the activity of the sympathetic nervous system, in which the fact of stimulation is subjectively felt by the patient in the form of a slight tingling or vibration of arbitrary frequency, and numbness of the earlobe does not occur. After each treatment procedure, cardiointervalography is performed, systolic and diastolic blood pressure is measured and vegetative tone is assessed. The treatment process is carried out until the estimates of the vegetative tone have reached the values characteristic of the autonomic equilibrium, or the vector of their changes will not have a steady direction towards the autonomic equilibrium compared with their values before treatment [11]. Some ways of using the hardware-software complex are described in [12-16]. However, if the described hardware-software complex is used for neurostimulation of processes in the brain tissue, due to the fact that only the projections of the superior cervical ganglia of the sympathetic nervous system and (or) the stellate ganglion are targeted, the possibilities of brain neurostimulation are significantly limited.

The technical result of the invention is to increase the efficiency of neuroelectrostimulation due to the involvement in the stimulation process, in addition to the autonomic nervous system, of pathways of other nerve formations in the neck in the absence of any difficulties with ensuring the sanitary and hygienic conditions of the treatment process and comfortable conditions for the patient. This is achieved by increasing the number of local exposure targets in the neck area with spatially distributed current pulses.

In FIG. 2 and 3 show the anatomical location of the nerve formations of the neck [17]. In FIG. 2 presents: 1 - glossopharyngeal nerve; 2 - pharyngeal plexus; 3 - pharyngeal branches of the vagus nerve; 4 - external carotid artery and nerve plexus; 5 - upper laryngeal nerve; 6 - internal carotid artery and sinus branch of the glossopharyngeal nerve; 7 - sleepy glomus; 8 - carotid sinus; 9 - the upper cervical cardiac branch of the vagus nerve; 10 - upper cervical cardiac nerve; 11 - middle cervical node of the sympathetic trunk; 12 - middle cervical cardiac nerve; 13 - vertebral node; 14 - recurrent laryngeal nerve; 15 - cervicothoracic (stellate) node; 16 - subclavian loop; 17 - vagus nerve; 18 - lower cervical cardiac nerve; 19 - chest cardiac sympathetic nerves and branches of the vagus nerve; 20 - subclavian artery; 21 - gray connecting branches; 22 - upper cervical node of the sympathetic trunk; 23 - vagus nerve. In FIG. 3 presents: 1 - hyoid nerve; 2 - an additional nerve; 3, 14 - sternocleidomastoid muscle; 4 - a large ear nerve; 5 - a small occipital nerve; 6 - a large occipital nerve; nerves to the anterior and lateral rectus muscles of the head; 8 - nerves to the long muscles of the head and neck; 9 - trapezius muscle; 10 - connecting branch to the brachial plexus; 11 - phrenic nerve; 12 - supraclavicular nerves; 13 - lower abdomen of the scapular-hyoid muscle; 15 - neck loop; 16 - sternum-hyoid muscle; 17 - sterno-thyroid muscle; 18 - upper abdomen of the scapular-hyoid muscle; 19 - the transverse nerve of the neck; 20 - lower root of the neck loop; 21 - the upper root of the neck loop; 22 - thyroid muscle; 23 - chin-hyoid muscle.

The most significant formations that participate in organizing the neuroelectrostimulation of the present invention: the glossopharyngeal nerve and its branches, the vagus nerve and its branches, the accessory nerve, the nerve plexuses around the carotid arteries, the formation of the sympathetic trunk: upper cervical ganglion, middle cervical ganglion, vertebral ganglion, stellate ganglion ; spinal nerves (C2-C4), forming the cervical plexus and incorporating afferent fibers.

In FIG. 4 shows the conditional areas of the location of these nerve formations on the neck.

Here are presented:

zone 1 - the area of primary location of the sympathetic trunk;

zone 2 - the area of primary location of the carotid plexus;

zone 3 - the area of primary location of the cervical spinal plexus;

zone 4 - the vagus nerve.

zone 5 - accessory nerve and branches of the glossopharyngeal nerves

The centers of regulation of vital functions are located in the nuclei of the brain stem, midbrain, bridge and cerebellum, as well as in the autonomic nuclei of the spinal cord and brain. Many of the pathways of these centers are located in the neck.

Somatic innervation of the neck is carried out by the cervical spinal nerves, which form a massive cervical plexus on the back of the neck. Afferent fibers pass through the posterior horns of the spinal cord and end in the sensitive nuclei of the brain stem and reticular formation. The reticular formation is involved in the processing of sensory information, and also has an activating effect on the cerebral cortex, thus controlling the activity of the spinal cord. With the help of this mechanism, the tone of skeletal muscles, as well as the autonomic functions of a person, is controlled. On the deep muscles of the neck are the nodes of the sympathetic trunk formed by the nerve processes of the autonomic nuclei of the spinal cord. The upper, middle and lower (stellate) sympathetic nodes have numerous branches that carry out the sympathetic innervation of the glands, meninges, vessels of the head, neck and spine. Near the main arteries of the neck lies the vagus nerve. Vagus nerve nuclei are located in the brainstem and are common to the glossopharyngeal nerve. They have extensive connections with the hypothalamus, olfactory system, and reticular formation. Together, the glossopharyngeal and vagus nerves carry out the parasympathetic innervation of most organs. Nerve formations in the neck are closely connected with the brain stem, through which they have bilateral connections with the bridge, midbrain, cerebellum, thalamus, hypothalamus and cerebral cortex. The presence of these connections ensures the participation of nerve formations of the neck in the analysis of sensory irritations, regulation of muscle tone, autonomic and higher integrative functions [18-20]. The use as targets of electrical stimulation of the cervical spinal plexus and branches of the vagus, glossopharyngeal and additional cranial nerves will allow stimulation of the gray matter of the brain stem along afferent pathways. And through the reticular formation, the effect can spread to the thalamic structures and the cerebral cortex. Stimulation of the nodes of the sympathetic trunk will allow influencing both the vascular tone of the cerebral arteries and the autonomic nuclei of the spinal cord.

Thus, the proposed system of neuroelectrostimulation is able to fully modulate autonomic processes, affect motor control and cognitive functions. Using as targets of stimulation not only the upper cervical ganglia of the sympathetic nervous system and (or) the stellate ganglion, but also the remaining nodes of the sympathetic trunk, afferent branches of the cervical plexus, cranial nerves and their branches (IX, X and XI pairs), which are conducting pathways of the neural formations of the brain stem, significantly expands the possibilities of neurostimulation of various processes in the tissues of the brain in the absence of any difficulties with ensuring the sanitary and hygienic conditions of the treatment process and com ortnyh conditions for the patient, which is the object of the present invention.

The essence of the invention is to increase the efficiency of neuroelectrostimulation for the formation of spatially distributed current pulses in any region of the neck symmetrically relative to each other or asymmetrically install two multi-element electrodes, the partial electrodes of which are isolated from each other and perform the functions of anodes and cathodes, respectively, when performing neuro-electrostimulation the supply of current pulses to the partial electrodes of a multi-element electrode, performing the functions of anodes, and the partial electrodes of another multi-electrode electrode, acting as cathodes, are carried out in such a way that the switching frequency of the partial electrodes of the multi-electrode electrode acting as anodes is less than the switching frequency of the partial electrodes of a multi-electrode electrode acting as cathodes. Switching (switching) of these partial electrodes is performed either clockwise or counterclockwise, or in random order according to a random law. The amplitude of the partial current pulses on the partial electrodes is from 0 to 100 mA, the duration of the current pulses on the partial electrodes is from 1 to 100 μs. The switching frequency between the partial electrodes of the first multi-electrode electrode is from 1 to 200 Hz, and the switching frequency between the partial electrodes of the second multi-electrode electrode is from 1 switching per second to the first switching in several minutes. The frequency of the current generated by the current pulses of the partial electrodes is from 1 to 200 Hz. The number of partial electrodes in a multi-electrode can be from 2 to 1024.

Additionally, when conducting neuroelectrostimulation, the bioelectrical activity of the brain is recorded using electroencephalography (EEG), and / or heart rate variability (HRV), and / or galvanic skin reaction (RAG).

In FIG. 5 shows one of the possible options for the algorithm of the proposed method of treatment:

- registration of biomedical signals;

- transmission via telemetric communication channel of biomedical signals;

- processing of biomedical signals;

- determination of functional disorders of the central and autonomic nervous systems;

- decision-making on the medical procedure;

- when deciding to "start" form a field of current pulses.

The process is repeated until at the stage of “decision-making on the medical procedure” a decision is made to “finish” the medical procedure.

The structural diagram of the invention is shown in FIG. 6. Here are presented: patient 1; the first multi-element electrode 2, the partial elements of which serve as the anode; a second multi-element electrode 3, the partial elements of which perform the functions of a cathode; there is the possibility of switching pulses between the partial electrodes of the multi-cell electrode, performing the function of the anodes, and switching pulses between the partial electrodes of the multi-cell electrode, performing the function of the cathodes; the switching frequency of the pulses between the partial electrodes of the multi-cell electrode that performs the function of the anodes is less than the frequency of switching pulses between the partial electrodes of the multi-cell electrode that performs the function of the cathodes; first switch 4; current source 5; block 6 sets the parameters of the field of current pulses; processor 7; second switch 8; sensors 9 of the functional state of the central and autonomic nervous systems; amplifying and converting unit 10. A multi-element electrode 2 and a multi-element electrode 3 are installed on the neck of the patient 1, and the sensors 9 of the functional state of the central and autonomic nervous systems are fixed on his body in areas in which the bioelectric activity of the brain and / or HRV are recorded and / or RAG. The inputs of the first multi-element electrode 2 are connected to the outputs of the first switch 4, the first input of which is connected to the output of the current source 5, and the second input is connected to the first output of the processor 7. The inputs of the second multi-electrode electrode 3 are connected to the outputs of the second switch 8, the input of which is connected to the second output processor 7. The outputs of the sensors 9 of the functional state of the central and autonomic nervous systems are connected to the input of the amplifier-transforming unit 10, the output of which are bioelectrical signals th activity of the brain, and / or HRV and / or RAG; these signals are fed to the first input of the processor 7, and to its second input, the signal from the output of the unit 6 for setting the parameters of the current pulse field.

The implementation of the device of the proposed method of neuroelectrostimulation can be performed using the following technical elements (here is the data on the positions of the structural diagram of Fig. 6):

- p. 2 and 3: multi-element electrodes can be implemented with the following characteristics

- the number of partial electrodes from 2 to 1024;

- diameter of partial electrodes from 1 to 25 mm;

- sizes of a multi-electrode from 10 × 10 mm to 100 × 300 mm;

, и конструкция их не должна содержать остроконечных образований;- partial electrodes should be implemented on the basis of conductive materials having a specific electrical resistance of less than

, and their design should not contain peaked formations;

;- in multi-element electrodes between partial electrodes should be placed structural elements having a resistivity of more

;

- one of the possible implementations of multi-element electrodes is shown in FIG. 7;

- p. 4 and 8: can be implemented using switch chips, for example ADG5401, ADG5408, ADG1408, or transistors, for example 2N7000, BS170, VP106;

- p. 5: a current source can be implemented using circuitry for voltage-controlled current sources, for example, using 2N7000, 2N7001, BC337, BC327 transistors and / or ORA333 type operational amplifiers;

- p. 6: the unit for setting biotropic parameters of the field of current pulses is the interface of processor 7 and its virtual version can be implemented using the program;

- p. 7: the processor can be implemented, for example, on the basis of a microcontroller of the MSP430F5, MSP430F6, STM32F0, STM32F1 family;

- p. 9: as sensors 9 of the functional state of the central and autonomic nervous systems, you can use the electrodes used to record EEG, ECG, RAG, etc .;

- p. 10: the amplifier-conversion unit 10 can be implemented using a variable-gain operational amplifier, for example OPA333, OPA334, INA132, INA2132, and the analog-to-digital converter ADS1610, ADS1675, ADS1278, TLC4545, ADS1194, ADS1294, ADS1298 and etc.

From the analysis of scientific, technical and patent literature it follows that the technical solutions of the proposed method of neuroelectrostimulation and a device for its implementation meet the criteria of "novelty" and "technical level".

Clinical examples of the use of a device for neurostimulation of processes in brain tissues

When evaluating the effectiveness of the treatment process, psychopathological, neuropsychological and neurological studies were used to evaluate the functional changes in the central and autonomic nervous systems according to EEG and HRV, respectively.

Since the EEG data reflect the bioelectrical activity of the brain and indicate the level of excitation of various brain structures not only in physiological conditions, but also in pathological conditions [21], and HRV is one of the most important markers of the activity of the autonomic nervous system not only in physiological conditions, but also pathological [22], these methods are chosen for an objective assessment of changes in the central and autonomic nervous system in clinical examples. Moreover, functional changes in the central and autonomic nervous system in pathological conditions cannot spontaneously change to a level corresponding to the physiological state. In addition, these methods are used without any restrictions in the clinical setting for the diagnosis and monitoring of the treatment process not only in Russia [23, 24], but also abroad [25, 26].

Example 1. Patient D., husband., 1974

The heredity of mental illness is not burdened. Grew up and developed in a prosperous family without psychophysical deviations. He graduated from the pedagogical university. Has two children.

In August 2011, as a result of an accident (fell from a bicycle), he received a severe head injury with loss of consciousness. He was hospitalized for three weeks in the neurological department with a diagnosis of moderate brain contusion. Symptomatic and neurometabolic therapy was performed. By the time of discharge, there were mild memory disorders for past events, slowness, rapid exhaustion, distraction. I didn’t get a job. By the summer of 2013, memory began to deteriorate sharply - he forgot commonplace household items, gradually ceased to recognize relatives, began to get lost in a familiar environment, periodically became extremely restless.

MRI of August 12, 2013: small focal leukoencephalopathy. Generalized cerebral atrophy of the 1st degree.

Inpatient and sanatorium treatment was carried out. At the same time, the condition continued to worsen: memory disorders increased, mental disorders worsened - periodically became confused, did not respond to speech, complained of great anxiety, “trembling in the body”.

On March 3, 2014, relatives turned to a psychiatrist for help. For two weeks he received therapy: carbamazepine 400 mg / day, akatinol 5 mg / day, cavinton 30 mg / day. Noticeable changes in the condition were not observed.

Inspection of March 15, 2014

Psychopathological research

He calls his name and surname, in the environment he is guided with a hint, does not know the current time, doubts his age. Answers only simple questions, misunderstands complex questions. He complains of inexplicable anxiety, “subcutaneous trembling,” insomnia, considers himself helpless and deeply unhappy. During the conversation, he reveals signs of pronounced fixative amnesia - he does not remember the events of five minutes ago, he does not remember the name of the doctor. The attention is scattered. Emotional reactions are labile: it easily becomes tearful, and also quickly calms down. Intelligence reduced. Counting operations are difficult when going through a dozen. Thinking stiff. Abstraction is not available. The vocabulary is small, it has difficulty in selecting words. Partial criticism of his condition, denies memory problems. The department spends most of the time in the ward. Passively communicates with other patients.

Neurological research

Cranial nerves without pathology. Gait with slight limp on the left leg. Coordination tests are unsatisfactory. In the Romberg position is unstable. Tendon reflexes from the lower extremities are increased.

EEG: Marked diffuse changes in the bioelectrical activity of the brain with a predominance of pathological activity (pointed sharp waves of the delta range up to 100 μV) in the parietal and occipital regions without foci. Dysfunction of the middle structures with a decrease in convulsive readiness.

HRV: Low total power of heart rate variability (0.6 ms ² ). Significant predominance of sympathetic influences over parasympathetic (LF / HF = 13.74), as well as mechanisms of central origin (VLFnorm = 44, l%).

Frontal Assessment Batter Batter [27]: 10 points, marked frontal dysfunction.

Montreal Cognitive Assessmnet [28]: 18 points, moderate cognitive decline.

Mini-Mental State [29]: 22 points, mild dementia.

Diagnosis: Psycho-organic syndrome, moderately expressed amnestic variant.

Therapy: a course of treatment of 5 neuroelectrostimulation procedures was prescribed, which were performed using a device, the technical solutions of which and the method of stimulating processes in the brain tissue with its help correspond to the claimed invention.

The treatment course consisted of 3 cycles: in the first cycle, exposure was performed for 6 minutes on zone 3; further, for 5 minutes there was no effect; in the second cycle, exposure to zone 4 for 6 minutes; further, for 5 minutes there was no effect; in the third cycle, exposure was performed for 6 minutes on zone 5; further, for 5 minutes, the effect was absent and the patient was in a state of functional rest. The choice of targets in the organization of neuroelectrostimulation of the claimed method in the treatment of patient D. was determined taking into account the revealed pathology of the central nervous system and the current state of the ANS. In the first cycle, the targets of exposure were the areas of the cervical spinal plexus; in the second cycle - the zone corresponding to the location of the vagus nerve, in the third cycle - the zone of passage of the accessory nerve and branches of the glossopharyngeal nerve. Thus, deep stimulation of the brain stem structures should be performed to correct the revealed disorders of the central nervous system, as well as the activation of intracerebral pathways that go back to the midbrain, reticular formation, thalamus and cortical centers of higher mental functions.

The amplitude of the current pulses on the partial electrodes was set to 7 mA, their duration was 30 μs, the switching frequency between the partial electrodes of the first multi-electrode electrode was set to 100 Hz, and the switching frequency between the partial electrodes of the second multi-electrode electrode was 1 switch in 30 seconds. Switching was carried out clockwise.

Inspection of March 26, 2014 (after a course of treatment of 5 neuroelectrostimulation procedures).

Psychopathological research

Clearly names his passport details. Oriented in time and surroundings. Answers simple and complex questions. Complaints of forgetfulness. Confused in dating events of the recent past. He does not find signs of fixative amnesia - he remembers the name of the doctor, names the perfect cases for the current day. Attention holds in sufficient volume. No complaints. Emotional reactions are poorly differentiated, but without signs of lability. Intellectual abilities are slightly reduced. Counting operations within 100 performs satisfactorily, including operations of multiplication and division. Thinking remains somewhat inhibited, it is difficult to switch to new topics. Abstraction is difficult. Explains the meaning of simple proverbs, the meaning of more complex interpretations is difficult. Having difficulty finding words. Critical of his condition. Notes significant difficulties in reproducing the recent past. However, he remembers current events quite well. Makes plans for the future, is going to find a job. He actively offers his help in the work of the department, participates in group classes. Does exercises. Helps other patients.

EEG: The main rhythm is clear, resistant to stress. Slight diffuse changes in the bioelectrical activity of the brain with indirect signs of dysfunction of the median structures are noted.

HRV: Normal total heart rate variability power (35.2 ms ² ). The balanced effect of sympathetic and parasympathetic autonomous mechanisms (LF / HF = 0.71), a slight severity of central regulation (VLFnorm = 6.9%).

Neuropsychological study

Frontal Assessment Batter [27]: 16 points - normal frontal function.

Montreal Cognitive Assessmnet [28]: 23 points - a slight decrease in cognitive function.

Mini-Mental State [29]: 28 points - no cognitive impairment.

Neurological research

Cranial nerves without pathology. The gait is confident, clear. Coordination tests are satisfactory. In the Romberg position is steady. Tendon reflexes are normal.

Conclusion on the dynamics of clinical data

As a result of the course of neuroelectrostimulation using a device, the technical solutions of which and the method of stimulating processes in the brain tissue with its help correspond to the claimed invention, the following dynamics of mental and neurological disorders is noted.

The motor functions were fully restored: the gait normalized, and coordinator tests were performed. I had a dream. The mood background has leveled off, the phenomena of emotional lability have passed. Fixative amnesia completely regressed. He began to navigate in time. The volume of active attention has increased. Thought processes recovered: logical, partially abstract thinking, ability to count operations improved. There was a critical attitude towards memory impairment and its condition in general.

Conclusion on the dynamics of functional changes in the central and autonomic nervous system (histograms of changes are shown in Fig. 8)

Conclusion on the dynamics of electroencephalography data (15.03 vs 26.03)

Alpha rhythm: a significant increase in power in the parietal leads, a slight increase in the central leads.

Beta rhythm: decreased power in the occipital leads, a slight increase in the central and parietal leads, and a significant increase in the frontal leads.

Theta rhythm: increased power in the frontal, parietal and central leads.

Delta rhythm: a significant decrease in power in all leads.

Thus, the EEG data indicate a change in the structure of brain activity after neuroelectrostimulation procedures. Namely, a shift in the ratio of brain rhythms towards fast-wave activity (alpha and beta range), an increase in rhythm stability and resistance to stress is also noted.

Conclusion on the dynamics of HRV data (15.03 vs 26.03)

HRV data before and after treatment indicate a change in the autonomic balance from sympathicotonia to normotonia. Also, there is an increase in the total power of HRV, which, along with a decrease in the VLF of the spectrum component, indicates an increase in the activity of the regulatory mechanisms of the autonomic nervous system.

Example 2. Patient C, male, b. 1976

The heredity of mental illness is not burdened. Grew up and developed in a prosperous family without psychophysical deviations. He served in the Russian army. He graduated from technical school and school of the Ministry of Internal Affairs. He served in the police. Since 2009, he began to abuse alcohol.

In December 2013, against the background of an abstinence state after a long period of alcoholization, an epileptic seizure developed during which he fell on the stairs. As a result of the fall, he received a head injury with loss of consciousness. He was hospitalized for five weeks in the intensive care unit with a diagnosis of severe brain contusion, subarachnoid hemorrhage, contusion foci in the left temporal and left parietal lobes. MRI of December 31, 2013: two large homogeneous foci of increased density in the left frontal and right temporal lobes of the cerebral cortex, cerebral atrophy of the II degree.

Symptomatic and neurometabolic therapy was performed. By the time of discharge, complete motor and elements of sensory aphasia, right-sided hemiparesis were noted. Inpatient treatment was continued in a specialized neurological department. At the time of discharge, noticeable changes in the state did not occur.

March 3, 2014 was transferred to the psychiatric ward to continue treatment. For two weeks he received therapy: carbamazepine 400 mg / day, gliatilin 800 mg / day. Noticeable changes in the condition were not observed.

Inspection of March 15, 2014

Psychopathological research

Contact is difficult due to motor aphasia and partial sensory aphasia. Understands simple speech addressed. He nods his head when voicing personal data. He misunderstands more complex issues, indiscriminately nods his head. Speech production is represented by two words - “well” and “yes”. It does not orient in time. Understands what is in the hospital. Recognizes relatives. Follows simple instructions. Neuropsychological tests are not performed or are unsatisfactory due to right-sided hemiparesis and apraxia elements. Counting operations are not performed. The emotional background throughout the conversation is complacent. Periodically smiles, chuckles. No initiative. The behavior is calm, obedient. Does not show a critical attitude to his condition. The department moves only with additional support. Spends time in the ward.

Neurological research

The face is asymmetric - the right half is slightly lowered. Pupils: the right is larger than the left, the photoreaction is sluggish. Right hemiparesis. The gait is broken, drags the right leg, moves only with support. Sensomotor aphasia. She understands the instructions of the coordinating tests after the demonstration and several presentations, and does it incorrectly. Physiological administration is controlled independently.

EEG: Marked changes in the bioelectrical activity of the brain with a predominance of pathological activity (pointed acute waves of theta and delta ranges above 100 μV) in the occipital and parietal regions. Dysfunction of the mid-stem structures. Separation of cortical-subcortical relationships. Decreased convulsive readiness with severe disorganization of the underlying rhythm.

HRV: Low total power of heart rate variability (6.9 ms ² ). The predominance of sympathetic influences over parasympathetic (LF / HF = 9.4), insignificant participation of mechanisms of central origin (VLFnorm = 6.9%).

Neuropsychological study

Not able to perform neuropsychological tests.

Frontal Assessment Batter Batter [18]: 0 points - marked frontal dysfunction.

Montreal Cognitive Assessmnet [19]: this test is not possible due to sensory-motor aphasia, elements of apraxia and right-sided hemiparesis.

Mini-Mental State [20]: 4 points - severe dementia.

Diagnosis: Organic damage to the central nervous system. Late recovery period. Sensomotor aphasia. Right hemiparesis.

Therapy: a course of treatment of 5 neuroelectrostimulation procedures was prescribed, which were performed using a device, the technical solutions of which and the method of stimulating processes in the brain tissue with its help correspond to the claimed invention.

The treatment course consisted of 3 cycles: in the first cycle, exposure was performed for 6 minutes on zone 1; further, for 5 minutes there was no effect; in the second cycle, exposure to zone 3 for 6 minutes; further, for 5 minutes there was no effect; in the third cycle, exposure was performed for 6 minutes on zone 4; further, for 5 minutes, the effect was absent and the patient was in a state of functional rest. The choice of targets in the organization of neuroelectrostimulation of the claimed method in the treatment of patient C. was determined taking into account the revealed pathology of the central nervous system and the current state of the ANS. In the first cycle, the targets of exposure were the areas of sympathetic trunk location; in the second cycle, the zone corresponding to the location of the cervical spinal plexus; in the third cycle - the vagus nerve zone. Thus, stimulation of the spinal sympathetic nucleus was performed to correct the revealed disorders of autonomic regulation, as well as stimulation of deep stem structures and ascending paths to the cortical formations of the brain.

The amplitude of the current pulses at the partial electrodes was set to 5 mA; their duration is 20 μs; the switching frequency of the partial electrodes of the first multi-electrode electrode, performing the functions of the cathode, was set to 150 Hz, and the switching frequency between the partial electrodes of the second multi-electrode electrode was 1 switching in 30 seconds. The switching of pulses between the partial electrodes was carried out in random order according to a random law.

Inspection of March 26, 2014 (after a course of treatment of 5 neuroelectrostimulation procedures).

Psychopathological research

Contact is difficult due to moderate motor aphasia. Understands addressed speech. Calls his name and age, calls his mother's name. Understands what is in the hospital. Recognizes the attending physician. Partially oriented in time - recognizes the time of year outside the window, names the current year. There are separate words in speech production, repeats the alphabet for the doctor, repeats the numbers up to 10. He has difficulty in pronunciation, sometimes it requires several presentations. Sometimes spontaneously clearly pronounces one or two words. Follows simpler and more complex instructions. Significantly decreased the elements of apraxia. Performs counting operations within 10 - shows on fingers. The emotional background is closer to a flat one. Sometimes he refuses to perform tasks, demonstrates discontent, hints that he is tired. To questions about the state of mental health, sadness is demonstrated, he answers “not very”. The behavior is ordered. In the department, he began to go out into the corridor more often, passively communicating with other patients.

Neurological research

The face is symmetrical. Pupils: the right is larger than the left, the photoreaction is live. The manifestations of right-sided hemiparesis decreased. The gait is broken, drags the right leg, but is able to move without support.

He assimilates the instructions of the coordinating tests and performs unsatisfactorily due to right-sided hemiparesis.

EEG: Moderately pronounced diffuse changes in the bioelectric activity of the brain with a violation of the cortical-subcortical relationships without pathological activity. The main rhythm is expressed quite resistant to stress tests.

HRV: The total power of heart rate variability (15.4 ms ² ) is slightly below normal. The influence of sympathetic mechanisms is not much greater than the influence of parasympathetic autonomous mechanisms (LF / HF = 1.96). Moderate severity of the mechanisms of central regulation of HRV (VLFnorm = 10.8%).

Neuropsychological study

Performs tests for reciprocal coordination, hand-eye coordination, dynamic praxis.

Frontal Assessment Batter [18]: 4 points - pronounced frontal dysfunction.

Mini-Mental State [20]: 12 points - moderate dementia.

Conclusion on the dynamics of clinical data

As a result of the course of neuroelectrostimulation, the following dynamics of mental and neurological disorders was noted:

significantly improved motor functions: began to move around without assistance. The phenomena of sensory and partially motor aphasia were regressed: impressive speech improved and expressive speech, elements of spontaneous speech appeared. The phenomena of apraxia decreased: he began to perform simple neuropsychological tests. The mood background normalized, the range of emotions experienced expanded. Thought processes improved, the ability to count operations appeared. Orientation in space has improved. There was minimal social activity.

Conclusion on the dynamics of functional changes in the central and autonomic nervous systems (histograms of changes are shown in Fig. 9)

Conclusion on the dynamics of electroencephalography data (15.03 vs 26.03)

Alpha rhythm: maintaining power in the back of the head and reducing power in the other leads.

Beta rhythm: increased power in the occipital and parietal leads, a slight decrease in power in the frontal and central leads.

Theta and delta rhythms: a significant decrease in power in all leads.

Thus, the EEG data indicate a change in the structure of brain activity after neuroelectrostimulation procedures. Namely, a shift in the ratio of brain rhythms towards fast-wave activity, stabilization and isolation of the leading beta rhythm with a predominance in the occipital leads.

Conclusion on the dynamics of HRV data (17.03 vs 26.03)

HRV data before and after treatment indicate a change in the autonomic balance from sympathicotonia to normotonia. An increase in the total power of HRV is also noted, which, along with an increase in the VLF component of the spectrum of HRV, indicates an increase in the activity of regulatory mechanisms of both the autonomic and central nervous systems.

Compared with the above clinical examples, the results obtained using the hardware-software complex, when the target of the exposure are only projections of the superior cervical ganglia of the sympathetic nervous system and (or) the stellate ganglion, the possibilities for neurostimulation of processes in the brain tissue are significantly limited: in this case only cerebral circulation can be regulated [12-16], and not processes determined by the functions of the central nervous system, such as motion control, memory, coordination I, perception and generation of speech, thinking, processing sensory information, planning, decision making, positive and negative emotions, attention, recognition, purposeful activity.

Despite the fact that in the clinical examples cited, only some of the possibilities of the present invention for neurostimulation of processes in brain tissues, such as motion control, memory, coordination, perception and speech generation, are considered, this indicates that with an increase in the number of local targets, the effects of spatially distributed With current pulses in the neck, adequate changes occur not only in the autonomic nervous system, but also in the central, primarily its sensory motor s and cognitive functions.

Thus, the above materials show the high efficiency of the claimed method of neuroelectrostimulation of processes in the tissues of the brain and the possibility of technical implementation of the device for its implementation.

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Claims (5)

1. The method of neuroelectrostimulation, including the formation of spatially distributed current pulses in the neck, characterized in that the first and second multi-element electrodes are installed on the neck, the partial electrodes of which are isolated from each other and perform the functions of anodes and cathodes, respectively, when performing neuroelectrostimulation, the supply of current pulses to the partial electrodes of the first multi-electrode and the partial electrodes of the second multi-electrode are carried out in such a way that the frequency The switching between the partial electrodes of the first multi-electrode is less than the switching frequency between the partial electrodes of the second multi-electrode. 2. The method according to p. 1, characterized in that the amplitude of the current pulses on the partial electrodes is from 0 to 100 mA, the duration of the current pulses on the partial electrodes is from 1 to 100 μs, the switching frequency between the partial electrodes of the first multi-element electrode is from 1 to 200 Hz, the switching frequency between the partial electrodes of the second multi-element electrode is from 1 switching per second to 1 switching in a few minutes, the frequency of the current generated by the current pulses of the partial electrodes s is from 1 to 200 Hz. 3. The method according to p. 1 or 2, characterized in that the electrodes are placed on the neck in any area, symmetrically relative to each other or asymmetrically. 4. The method according to p. 1 or 2, characterized in that the switching of pulses between the partial electrodes is carried out clockwise, or counterclockwise, or in random order according to a random law. 5. A device for implementing the method according to PP. 1-4, containing the first and second multi-element electrodes, the partial electrodes of which are isolated from each other and perform the functions of anodes and cathodes, respectively, while the first multi-element electrode is connected through a first switch to a processor connected to a job unit through a second switch parameters of current pulses and configured to generate a switching frequency between partial electrodes of the first multi-element electrode is less than the switching frequency between artsialnymi electrodes of the second multi-element electrode.

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