RU2653681C2 - Device for neuroelectrostimulation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical technology, namely to the means for neuroelectrostimulation. Device is implemented in the form of at least two units that are connected by a telemetry communication channel, where at least one first unit generates spatially distributed current pulses and registers biomedical signals and contains a first multi-element electrode whose partial elements perform the functions of anodes, the second multi-element electrode, the partial elements of which perform cathode functions, the first and second switches, the current source, the processor, sensors of the functional state of the central and autonomic nervous systems, the amplifying-converting unit and the unit for setting the parameters of the current pulses. Second unit analyzes biomedical signals, generates and sets parameters of spatially distributed current pulses, structure and characteristics of the distribution of these impulses in the neck region, depending on the changes in these signals. In the first of these units, the first telemetry channel transceiver is additionally introduced, and in the second one the second telemetry channel transceiver and the second processor. Use of the invention allows for the organization of rehabilitation to use simultaneously with neuroelectrostimulation a combination of several types of stimulation, each of which provides different types of physiological responses to damaged cognitive and motor functions.

EFFECT: best efficiency of the treatment process is achieved when, for example, such functional tests as walking, running, exercise bike, exercise stress et cetera, and also due to the fact that one doctor can simultaneously manage several treatment procedures.

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Description

The invention relates to the field of medical equipment and is intended for the treatment of various diseases in an inpatient or outpatient setting and can be used in neurology, psychiatry, in the replacement therapy of sensory systems, in enhancing protective functions in a person when he is in conditions of increased stress loads, and also sports and preventive medicine.

Analogues of the present invention are various options for neurostimulation using physical fields, the implementation of which it is possible to organize a direct impact 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 [1], programmable electrical neurostimulator [3] and non-invasive cranial nerve neuromodulator PoNS [4].

During transcranial electrical stimulation [1], 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 pulses with a repetition rate of (10-12) kHz is used, which the same duration against the background of the DC component when the ratio of the current strength of these signals is 1 to 2. The magnitude 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" exposed to areas of the cerebral cortex [2].

Programmable electrical neurostimulator allows you to act on the central and peripheral nervous systems through implanted electrodes [3]. 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 PoNS allows you to act on the central and peripheral nervous system using multi-channel stimulation of the tongue by electric current pulses [4]. 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 PoNS are described in [5-8]. The disadvantages of the PoNS 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 an electric stimulation of the oral cavity for more than 1-2 minutes.

Some devices for neurostimulation of processes in brain tissues are described in [9–11]. However, since here the target for neurostimulation is only the projection of the superior cervical ganglia of the sympathetic nervous system and (or) the stellate ganglion, the possibilities of brain neurostimulation are significantly limited.

The closest analogue to neurostimulation of processes in brain tissues is a method of neuroelectrostimulation and a device for its implementation, the structural diagram of which is shown in FIG. 1 [12]. Here are: 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.

Currently, neurorehabilitation systems using a combination of several types of stimulation are considered the most effective, each of which provides different types of physiological reactions of damaged cognitive and motor functions. This is necessary for the specific attraction of new neuronal resources precisely to that damaged neural network, which ensures the functioning of the rehabilitated function [13]. A similar principle has long been applied in constructing effective physical rehabilitation programs using percutaneous muscle stimulation [14]. According to modern concepts, physical and cognitive loads during neurorehabilitation can increase the production of neurotrophic factors and activate systems of mirror neurons [15]. Neurotrophic factors realize the mechanisms of brain neuroplasticity, and mirror neurons are able to remodel lost functions [16].

When organizing neurorehabilitation systems using a combination of several types of stimulation, each of which provides different types of physiological reactions of damaged cognitive and motor functions, the best efficiency can be achieved by using equipment that:

1. Must be compact and mobile;

2. can be used by a doctor in the rehabilitation of several patients at the same time;

3. can provide during rehabilitation monitoring of changes in the patient's central and autonomic nervous systems in real time;

4. Does not cause discomfort to patients during rehabilitation procedures.

The method of neuroelectrostimulation and device for its implementation [12] provides the formation of current pulses in the neck between two multi-electrode electrodes, setting the parameters of spatially distributed current pulses, the structure and distribution characteristics of these pulses in the neck, as well as measuring and analyzing the functional state of the central and vegetative nervous systems of the patient. These functions are carried out in one monoblock and the implementation of the above conditions of best efficiency in the rehabilitation of damaged cognitive and motor functions is almost impossible. This reduces the effectiveness of the treatment process of neurorehabilitation.

The essence of the invention consists in dividing the neurostimulation device into at least two blocks: at least one first block generates spatially distributed current pulses and registers biomedical signals, and the second block analyzes biomedical signals, generates and sets the parameters of spatially distributed current pulses, structure and characteristics the distribution of these impulses in the neck, depending on the change in these signals. To organize communication between these blocks, a telemetric communication channel is introduced between them, the first transceiver of which is installed in the first block, and the second transceiver in the second block. In addition, a parameter setting unit and a second processor are introduced into the second block, which analyzes the biomedical signals and generates data for changing the parameters of spatially distributed current pulses, as well as the structure and distribution characteristics of these pulses in the neck region. To control the rehabilitation of one patient by a doctor, information is exchanged between the first transceiver installed in the first block and the second transceiver installed in the second block through a telemetric communication channel.

In the particular case of execution, the biomedical signals are the bioelectrical activity of the brain, and / or heart rate variability and / or galvanic skin reaction.

In addition, N-first blocks can be included in the neurostimulation device (for managing a doctor’s rehabilitation processes for a group of N-patients), and information is exchanged between any of the N-first blocks and the second block through a telemetric communication channel.

The technical results are to increase the effectiveness of neurostimulation of the treatment process, in particular:

1. the implementation of the separation of the neurostimulation device into two blocks allows the first block to be compact and mobile, since part of the tasks of the neurostimulator, if it is implemented as a monoblock, are transferred to the second block;

2. the implementation of the first block is compact and mobile allows you to exclude the formation of discomfort in patients during rehabilitation procedures;

3. since the second unit can provide an independent analysis of biomedical signals about the functional state of the central and autonomic nervous systems in a group of patients, the formation of parameters of spatially distributed current pulses, the structure and distribution characteristics of these pulses in the neck, the simultaneous control of the rehabilitation process of a group of patients can one doctor.

The essence of the invention is illustrated by the structural diagram, which is presented in FIG. 2.

Here are: patient 1; the first block 12, including the first multi-element electrode 2, the partial elements of which serve as the anode; the second multi-element electrode 3, the partial elements of which serve as the cathode, the first switch 4, the current source 5, the first processor 6, the second switch 8, the sensors 9 of the functional state of the central and autonomic nervous systems, amplifier-converting unit 10, the first transceiver 11 of the telemetric communication channel ; telemetric communication channel 13; and the second unit 14, including the unit for setting the parameters of the current pulses, the second transceiver 15 of the telemetric communication channel, the second processor 16. 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 with the first output of the first processor 6. The inputs of the second multi-element electrode 3 are connected to the outputs of the second switch 8, the input of which is connected to the second output of the first processor 6. The outputs of the sensors 9 functional state I of the central and autonomic nervous systems are connected to the input of the amplifier-transforming unit 10, the output signal of which is the signals of bioelectrical activity of the brain, and / or heart rate variability and / or galvanic skin reaction; the output signals of the amplifier-converting unit 10 are supplied to the first input of the first processor 6. The third output of the first processor 6 is connected to the first input of the first transceiver 11 of the telemetric communication channel. The second input of the first processor 6 is connected to the first output of the first transceiver 11 of the telemetric communication channel. The second output of the first telemetry channel transceiver 11 is connected to the first input of the telemetry communication channel 13. The second input of the first telemetry channel transceiver 11 is connected to the first output of the telemetric communication channel 13. The second output of the telemetry communication channel 13 is connected to the first input of the second telemetry communication channel 13 The second input of the telemetric communication channel 13 is connected to the first output of the second transceiver 15 of the telemetric communication channel. The second output of the second telemetry channel transceiver 15 is connected to the first input of the second processor 16. The second input of the second telemetry channel transceiver 15 is connected to the first output of the second processor 16. The second output of the second processor 16 is connected to the first input of the current pulse parameter setting unit 7. The second input of the second processor 16 is connected to the first output of the unit 7 for setting the parameters of the field of current pulses.

The communication between the first block 12 and the second block 14 is carried out through the telemetric channel 13. For this, the first telemetry channel transceiver 11 is placed in the first block 12, and the second telemetry channel transceiver 15 is placed in the second block 14. To exchange a patient’s rehabilitation process with a doctor Information between the first transceiver 11 installed in the first block 12 and the second transceiver 15 installed in the second block 14 is carried out via the telemetric communication channel 13. For control detecting physician rehabilitation processes groups of N-patients in the neurostimulation device further includes (N-1) of the first block 12, and the exchange of information between any of the N-first blocks 12 and the second block 14 is also carried out via a telemetry communication link 13.

The implementation of the device for neuroelectrostimulation can be performed using the following technical elements (data on the positions of the structural diagram of Fig. 2 are given here):

П. 2 и 3: многоэлементные электроды могут быть реализованы со следующими характеристиками

Items 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. 3;

П. 4 и 8: могут быть реализованы при помощи микросхем переключателей, например, ADG5401, ADG5408, ADG1408, либо транзисторов, например, 2N7000, BS170, VP106;

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

П. 5: источник тока может быть реализован при помощи аккумулятора, например, типа Nokia BL-5C, и схемотехнических решений источников тока, управляемых напряжением, например, при помощи транзисторов 2N7000, 2N7001, ВС337, ВС327 и/или операционных усилителей типа ОРА333;

Section 5: a current source can be implemented using a battery, for example, Nokia BL-5C type, and circuitry solutions for voltage controlled current sources, for example, using 2N7000, 2N7001, BC337, BC327 transistors and / or OPA333 type operational amplifiers;

П. 6: процессор может быть реализован, например, на основе микроконтроллера семейства Texas Instruments MSP430F5, Texas Instruments MSP430F6, STMicroelectronics STM32F0, STMicroelectronics STM32F1;

P. 6: the processor can be implemented, for example, based on a microcontroller family of Texas Instruments MSP430F5, Texas Instruments MSP430F6, STMicroelectronics STM32F0, STMicroelectronics STM32F1;

П. 9: в качестве датчиков 9 функционального состояния центральной и вегетативной нервных систем можно использовать, например, электроды, применяемые при записи ЭЭГ, ЭКГ, КГР;

P. 9: as sensors 9 of the functional state of the central and autonomic nervous systems, for example, electrodes used when recording EEG, ECG, RAG can be used;

П. 10: усилительно-преобразующий блок 10 может быть реализован при помощи операционного усилителя с переменным коэффициентом усиления, например, ОРА333, ОРА334, INA132, INA2132, и аналого-цифрового преобразователя ADS1610, ADS1675, ADS1278, TLC4545, ADS1194, ADS1294, ADS1298;

Item 10: the amplifier-converting 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;

П. 11 и 15: первый и второй приемопередатчики телеметрического канала связи могут быть реализованы на основе технологий Wi-Fi, Bluetooth, ZigBee и т.д., при помощи приемопередатчиков ISM-диапазонов и т.п., например, при помощи модулей Bluegiga WT12, Bluegiga Ble112, Bluegiga WF121, Nordic Semiconductor nRF905, XB23-BWIT-004;

Items 11 and 15: the first and second telemetry channel transceivers can be implemented based on Wi-Fi, Bluetooth, ZigBee, etc. technologies, using ISM transceivers, etc., for example, using Bluegiga modules WT12, Bluegiga Ble112, Bluegiga WF121, Nordic Semiconductor nRF905, XB23-BWIT-004;

П. 12: телеметрический канал связи формируется в воздушной среде.

P. 12: a telemetric communication channel is formed in the air.

П. 14: второй процессор может быть реализован, например, с использованием устройств типа смартфон или персонального компьютера;

P. 14: the second processor can be implemented, for example, using devices such as a smartphone or personal computer;

П. 7: блок задания параметров импульсов может быть реализован в виде графического пользовательского интерфейса с помощью программы во втором процессоре 16 второго блока 14.

P. 7: the unit for setting the parameters of the pulses can be implemented as a graphical user interface using the program in the second processor 16 of the second block 14.

From the analysis of scientific, technical and patent literature it follows that the technical solutions of the claimed device for neuroelectrostimulation meet the criteria of "novelty" and "technical level".

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

In the following clinical examples, neuroelectrostimulation was performed by a device whose block diagram is shown in FIG. 2, and the technical elements described above were used during implementation (see data on pages 10-12). Neuroelectrostimulation procedures were performed simultaneously for both patients, for which the first two blocks were used in the device for neuroelectrostimulation, with the help of which spatially distributed current pulses were formed for each patient and biomedical signals were recorded to control functional changes in the central and autonomic nervous systems according to the electroencephalogram (EEG) and analysis of heart rate variability (HRV), and one second block, which provided in both patients an independent Allz above biomedical signals. For each patient in the second block, data were calculated on the parameters of spatially distributed current pulses, the structure and distribution characteristics of these pulses in the neck. Simultaneous management and control of the treatment process was performed by one doctor.

The choice of targets in the organization of neuroelectrostimulation of the claimed method in the treatment of patients was determined taking into account the revealed pathology of the central nervous system and the current state of the ANS. Possible electrostimulation zones are shown in FIG. 4 in the patent RU No. 2580972 [12]:

зона 1 - область преимущественного расположения симпатического ствола;

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

зона 2 - область преимущественного расположения сонного сплетения;

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

зона 3 - область преимущественного расположения шейного спино-мозгового сплетения;

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

зона 4 - блуждающий нерв;

zone 4 - the vagus nerve;

зона 5 - добавочный нерв и ветви языкоглоточного нервов.

zone 5 - additional nerve and branches of glossopharyngeal nerves.

Simultaneously with neuroelectrostimulation, motor and cognitive loads were performed.

During the motor neuroelectrostimulation procedure, the patient was offered to walk on the INTENSOR T100 fitness track simulator at a predetermined speed of 1.2 km / h as a motor load. For visual control of the position of the legs while walking, the patient had the opportunity to observe the movement of his legs with the help of a monitor in front of him, to which information came from an outdoor video camera.

As a cognitive load, tests were selected from the set of The Human Cognition Project, taking into account the identified violations of intellectual-mnestic activity. Test tasks were performed on a tablet computer and included a test for visual short-term and working memory [17].

When evaluating the effectiveness of the treatment process, standardized neuropsychological tests were used and functional changes in the central and autonomic nervous systems were recorded according to EEG and HRV, respectively. The following were used as standardized neuropsychological tests:

Frontal Assessment Batter Battery, который представляет собой набор моторных тестов, отражающих функцию и связи лобной коры больших полушарий головного мозга. Пациент выполнял эти тесты по инструкции врача. Оценивалось качество исполнения теста с помощью балльной оценки [18].

Frontal Assessment Batter Battery, which is a set of motor tests that reflect the function and connections of the frontal cortex of the cerebral hemispheres. The patient performed these tests as instructed by the doctor. The quality of the test was evaluated using a score [18].

Montreal Cognitive Assessment, который представляет собой набор когнитивных задач, оценивающих различные виды мышления и памяти пациента. Оценивалось качество исполнения задания с помощью балльной оценки [19].

Montreal Cognitive Assessment, which is a set of cognitive tasks that evaluate different types of thinking and memory of the patient. Evaluated the quality of the assignment using a score [19].

Mini-Mental State Examination, который представляет собой набор простых когнитивных задач. Оценивалась правильность выполнения инструкций. Дается балльная оценка [20].

Mini-Mental State Examination, which is a collection of simple cognitive tasks. Evaluated the correct implementation of instructions. A score is given [20].

Patient B., male, born 1958

Анамнез.

Anamnesis.

The heredity of mental illness is not burdened. Grew up and developed in a prosperous family without psychophysical deviations. He graduated from college, with a degree in electrician. Married, has two children. In March 2010, as a result of an industrial injury (fell from a height), he received a severe head injury with loss of consciousness. For seven weeks he was hospitalized in the neurological department with a diagnosis of severe brain contusion, open fracture of the left temporal bone, closed indented fracture of the parietal bone, subarachnoid hemorrhage, hemosinus. Surgical treatment was carried out, intensive symptomatic therapy. The condition has stabilized. At the time of discharge, marked memory disorders, motor aphasia, right-sided hemiparesis were noted. The symptoms of depression with dysphoria began to increase gradually, convulsive syndrome joined. Repeatedly underwent inpatient treatment in the neurological department. He received neurometabolic, vascular, antidepressant drug therapy, including using transcranial magnetic stimulation with the MagPro R30 apparatus. Motor functions improved, mobility began to improve, the function of the right upper limb improved, and motor aphasia decreased. Pronounced memory disorders for current and past events persisted, poorly orientated in the usual environment, experienced a depressed mood with periodic outbreaks of irritability. The condition remained without significant positive dynamics. One disability group was issued.

MRI from 05/07/2014: postcunison cystic-gliotic changes in the left temporal and parietal lobes, internal open compensated hydrocephalus against the background of cerebral atrophy of 2 degrees.

Осмотр от 09 октября 2014 г.

Inspection of October 09, 2014

Psychopathological research.

Calls his first and last name. In the environment does not navigate, can not say where it is. With a hint, calls the current date. The mood background is reduced, annoyed when he can not find the words to answer the next question. He gives short answers to most of the questions. He is not particularly interested in the conversation, formally agrees with the need for treatment. Complaints of irritability, fatigue, headache. The name of the doctor does not remember. Counting operations are difficult when going through a dozen. Neuropsychological tests are performed slowly with significant errors. Thinking stiff. Abstraction is not available. Vocabulary is small. There is no criticism of his condition.

Neurological research.

The gait is broken, legs are widely spread, it cannot pass in a straight line. Coordination tests are unsatisfactory. In the Romberg position is unstable. Tendon reflexes from the lower extremities are increased.

According to the EEG: against the background of regional slowdown, a dominant epileptic focus is observed in the left occipital-posterior temporal-parietal region involving non-specific median brain structures.

[21].According to HRV: low total power of heart rate variability, TP = 0.6 ms ² . Significant predominance of sympathetic influences over parasympathetic

[21].

Neuropsychological study:

по Frontal Assessment Batter Battery - 9 баллов, выраженная лобная дисфункция;

Frontal Assessment Batter Battery - 9 points, marked frontal dysfunction;

по Montreal Cognitive Assessment - 12 баллов, выраженное снижение когнитивных функций;

according to Montreal Cognitive Assessment - 12 points, a pronounced decrease in cognitive functions;

по Mini-Mental State Examination - 20 баллов, легкая деменция.

Mini-Mental State Examination - 20 points, mild dementia.

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

Therapy.

A course of treatment of 10 procedures of neuroelectrostimulation was prescribed. Each procedure consisted of 2 cycles. In the first cycle, exposure was performed for 5 minutes on zone 1. Zone 1 corresponds mainly to the upper and middle nodes of the sympathetic trunk, which are involved in the innervation of the tone of the medium and small arteries that supply blood to the brain. Due to the effect on these nerve formations, it is possible to increase blood supply to the brain and form a neurometabolic effect [22].

Further, for 5 minutes there was no effect. During the entire first cycle, the patient performed a cognitive load - memory matrix test [13], which develops visual short-term and working memory. In the second cycle, exposure was performed for 5 minutes on zone 3. Zone 3 is the area of the predominant location of the cervical spinal plexus, afferent fibers of which 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 tonus of skeletal muscles is controlled. Thus, due to the impact on these nerve formations, the patient's sensorimotor reactions can be enhanced [22].

Further, for 5 minutes there was no effect. During the entire time of the second cycle, the patient performed a motor test on the track simulator.

The parameters of spatially distributed current pulses, the structure and distribution characteristics of these pulses in the neck were selected in accordance with the EEG and HRV data before the treatment procedure and the recommendations given in [23]. Since patient B. showed a significant predominance of sympathetic influences over parasympathetic and, according to clinical and instrumental functional studies, a psychoorganic syndrome, a moderately pronounced amnestic variant was formed, the following parameters of spatially distributed current pulses were established: the amplitude of the current pulses on the partial electrodes during each procedure was established 7 mA, their duration is 40 μs, the switching frequency between the partial electrodes of the first many element electrode was set to 80 Hz, and the frequency switching between the partial electrodes of the second electrode multielement - 1 switch every 30 seconds. Switching was carried out clockwise.

Осмотр от 20 октября 2014 г.

Inspection of October 20, 2014

Psychopathological research.

He calls his name and surname, is well-versed in the environment, calls the current date. 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. The mood background is even. Emotional reactions are alive. No signs of irritability. No complaints. Counting operations within 100 performs satisfactorily. Neuropsychological tests are performed without errors and prompts. The abstract meaning of the proverbs understands enough. Makes plans for the future, is going to find a job.

Neurological research.

Cranial nerves without pathology. Confident gait. Coordination tests are satisfactory. A short time is stable in the Romberg position. Tendon reflexes from the lower extremities are increased.

According to the EEG: the basic rhythm is clear; diffuse changes in the bioelectrical activity of the brain are noted with the appearance of sharp-slow waves during exercise tests (hyperventilation and light stimulation) with indirect signs of dysfunction of the median structures. True epiactivity is not recorded.

According to HRV: the total power of HRV was normalized, TP = 29.8 ms ² . The balanced influence of sympathetic and parasympathetic autonomous mechanisms,

Neuropsychological study:

по Frontal Assessment Batter Battery - 15 баллов, нормальная лобная функция;

Frontal Assessment Batter Battery - 15 points, normal frontal function;

по Montreal Cognitive Assessment - 22 балла, легкое снижение когнитивных функций;

according to Montreal Cognitive Assessment - 22 points, a slight decrease in cognitive functions;

по Mini-Mental State Examination - 26 баллов, легкие нарушения когнитивных функций.

Mini-Mental State Examination - 26 points, mild cognitive impairment.

Conclusion on the dynamics of clinical data

As a result of the course of neuroelectrostimulation, a positive dynamics of mental and neurological disorders was 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. The volume of active attention has increased. Thought processes have recovered: logical, abstract thinking has improved. There are plans for the future.

Conclusion on the dynamics of EEG data: there is a restoration of normal background cortical activity and increased resistance to stress (hyperventilation and light stimulation).

Conclusion on the dynamics of HRV data: there is a change in the autonomic balance towards normotonia, an increase in the total power of HRV, which indicates an increase in the activity of regulatory mechanisms of the autonomic nervous system.

General conclusion.

After a course of neuroelectrostimulation, carried out in conjunction with motor and cognitive loads, a significant improvement in the patient's cognitive and motor status was noted compared with the indicators before treatment.

Patient O., male, 56 years old

Анамнез.

Anamnesis.

The heredity of mental illness is not burdened. Grew up and developed in a prosperous family without psychophysical deviations. Pianist. Married. Have no children. Abused alcohol for 10 years. In January 2010, as a result of poisoning with surrogate alcohol, cognitive skills sharply worsened: became confused, poorly oriented in a familiar environment, misunderstood conversations, did not record current information. A general tremor appeared, the gait was disturbed. Repeatedly underwent treatment in neurological and psychiatric departments. Received specific medications. The condition persisted almost without dynamics. Defined 1 group of disability. The condition worsens: periodically becomes anxious, fussy, aggressive. He began to smoke a lot (he smokes cigarettes before the filter, burns his fingers). I stopped monitoring my appearance.

Осмотр от 09 октября 2014 г.

Inspection of October 09, 2014

Psychopathological research.

He calls his name and surname, does not orient himself in the environment: he does not know where he is and on which floor, he does not date, he is difficult to determine his age. The mood background is slightly reduced, inexpressive, a little inhibited. Answers questions in monosyllables. He does not understand difficult questions. No complaints. 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. 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. There is no criticism of his condition. His condition is not burdened.

Neurological research.

Gait - legs wide apart, staggering. Coordination tests are performed satisfactorily while sitting. In the Romberg position is unstable. Tendon reflexes from the lower extremities are increased.

.According to the EEG: a disorganized rhythm with a lot of slow waves in the background recording. In the temporal regions, pathological pointed waves, epileptiform complexes with a tendency to spread to neighboring brain regions are registered bilaterally. According to HRV: high total power of heart rate variability, TP = 45.5 ms ² ; the predominance of parasympathetic influences over sympathetic,

.

Neuropsychological study:

по Frontal Assessment Batter Batter - 7 баллов, тяжелая лобная дисфункция;

Frontal Assessment Batter Batter - 7 points, severe frontal dysfunction;

по Montreal Cognitive Assessmnet - 13 баллов, среднетяжелое когнитивное снижение;

Montreal Cognitive Assessmnet - 13 points, moderate cognitive decline;

по Mini-Mental State - 17 баллов, деменция умеренной степени выраженности.

Mini-Mental State - 17 points, moderate dementia.

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

Therapy: a course of treatment of 10 neuroelectrostimulation procedures has been prescribed.

Each procedure consisted of 2 cycles. In the first cycle, exposure was carried out for 5 minutes on zone 1. Further, for 5 minutes there was no exposure. During the first cycle, the patient performed a cognitive load - memory matrix test [13], which develops visual short-term and working memory. In the second cycle, exposure was carried out for 5 minutes on zone 3. Further, for 5 minutes there was no exposure. During the entire time of the second cycle, the patient performed a motor test on the track simulator.

The parameters of spatially distributed current pulses, the structure and distribution characteristics of these pulses in the neck were selected in accordance with the EEG and HRV data before the treatment procedure and the recommendations given in [23]. Since the patient O. showed a significant predominance of parasympathetic influences over the sympathetic and, according to clinical and instrumental functional studies, a psychoorganic syndrome, a moderately pronounced amnestic variant was formed, the following parameters of spatially distributed current pulses were established: the amplitude of the current pulses on the partial electrodes during each procedure was established 3 mA, their duration is 30 μs, the switching frequency between the partial electrodes of the first many element electrode was set to 100 Hz, a switching frequency between the partial electrodes of the second electrode multielement - 1 switch every 30 seconds. Switching was carried out clockwise.

Осмотр от 20 октября 2014 г.

Inspection of October 20, 2014

Psychopathological research.

Oriented in his personality and surrounding space. Calls the current date with a hint, does not follow the time. The mood background is even. Emotional reactions are alive. Actively joins the conversation. The speech is simple, it has difficulty in selecting words. No complaints. It does not detect signs of fixative amnesia - it reproduces the events of the recent past, remembers the name of the doctor. It is difficult to recall the events of the last three years. Counting operations with a hint when going through a dozen. Makes plans for the future - is going to find piecework. Configured to completely abandon alcohol.

Neurological research.

Cranial nerves without pathology. The gait is smooth, somewhat slow. Coordination tests are satisfactory. In the Romberg position, only a short time is stable. Tendon reflexes from the lower extremities are increased.

According to the EEG: the basic rhythm is clear; diffuse changes in the bioelectric activity of the brain are observed during stress tests (hyperventilation, light stimulation).

.According to HRV: normal total power of heart rate variability, TP = 32.4 ms ² . The balanced influence of sympathetic and parasympathetic autonomous mechanisms,

.

Neuropsychological study:

по Frontal Assessment Batter - 13 баллов, легкое нарушение лобной функции;

Frontal Assessment Batter - 13 points, mild impairment of frontal function;

по Montreal Cognitive Assessmnet - 20 баллов, легкое снижение когнитивных функций;

according to Montreal Cognitive Assessmnet - 20 points, a slight decrease in cognitive functions;

по Mini-Mental State - 21 балл, легкая деменция.

according to Mini-Mental State - 21 points, mild dementia.

Conclusion on the dynamics of clinical data

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

The motor functions were significantly restored: the gait normalized, and coordination tests were performed. I had a dream. The mood background has leveled off, the phenomena of emotional lability have passed. Fixative amnesia completely regressed. The volume of active attention has increased. Thought processes have recovered: logical, abstract thinking has improved. There are plans for the future.

Conclusion on the EEG dynamics: restoration of normal background cortical activity, increased resistance to loads (hyperventilation, light stimulation).

Conclusion on the dynamics of HRV data: a change in the autonomic balance towards normotonia, an increase in the total power of HRV, which indicates an increase in the activity of regulatory mechanisms of the autonomic nervous system.

General conclusion:

After a course of neuroelectrostimulation, carried out in conjunction with motor and cognitive loads, a significant improvement in the patient's cognitive and motor status was noted compared with the indicators before treatment.

From the analysis of scientific, technical and patent literature it follows that the technical solutions of the neuroelectrostimulation device meet the criteria of “novelty” and “technical level”.

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Claims (4)

1. Device for neuroelectrostimulation, made in the form of at least two blocks that are connected by a telemetric communication channel, where at least one first block generates spatially distributed current pulses and detects biomedical signals and contains a first multi-element electrode, the partial elements of which serve as anodes; the second multi-element electrode, the partial elements of which serve as cathodes; the first and second switches, a current source, a processor, sensors of the functional state of the central and autonomic nervous systems, an amplifying-transforming unit and a unit for setting parameters of current pulses, and the second block analyzes biomedical signals, generates and sets parameters of spatially distributed current pulses, structure and distribution characteristics these impulses in the neck, depending on the change in these signals; the first of these blocks additionally introduced the first transceiver of the telemetric communication channel, and in the second - the second transceiver of the telemetric communication channel and the second processor. 2. The device according to p. 1, characterized in that the biomedical signals are the bioelectrical activity of the brain, and / or heart rate variability, and / or galvanic skin reaction. 3. The device according to claim 1, characterized in that several N first blocks can be included in the device for neurostimulation, and the exchange of information between any of the N first blocks and the second block is also carried out through a telemetric communication channel. 4. The device according to paragraphs. 1-3, characterized in that the first block contains the first and second multi-element electrodes, the first and second switches, the current source, the first processor, the sensors of the functional state of the central and autonomic nervous systems, the first transceiver of the telemetric communication channel, and the second block contains the second a telemetric communication channel transceiver, a second processor and a current pulse parameter setting unit; communication between the first and second blocks is carried out via a telemetric communication channel; the third output of the first processor is connected to the first input of the first transceiver of the telemetric communication channel, and the second input of the first processor is connected to the first output of the first transceiver of the telemetric communication channel; the second output of the first transceiver of the telemetric communication channel is connected to the first input of the telemetric communication channel, and the second input of the first transceiver of the telemetric communication channel is connected to the first output of the telemetric communication channel; the second output of the telemetric communication channel is connected to the first input of the second transceiver of the telemetric communication channel, and the second input of the telemetric communication channel is connected to the first output of the second transceiver of the telemetric communication channel; the second output of the second telemetry channel transceiver is connected to the first input of the second processor, and the second input of the second telemetry channel transceiver is connected to the first output of the second processor; the second output of the second processor is connected to the first input of the current pulse field parameter setting block, and the second input of the second processor is connected to the first output of the current pulse field parameter setting block.

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