WO2021203719A1 - Thérapie de neuromodulation par stimulation acoustique-électrique et appareil combinant un test, une analyse et un contrôle d'électroencéphalogramme - Google Patents
Thérapie de neuromodulation par stimulation acoustique-électrique et appareil combinant un test, une analyse et un contrôle d'électroencéphalogramme Download PDFInfo
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/3603—Control systems
- A61N1/36031—Control systems using physiological parameters for adjustment
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/70—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mental therapies, e.g. psychological therapy or autogenous training
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
- A61M2021/0027—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the hearing sense
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2230/00—Measuring parameters of the user
- A61M2230/08—Other bio-electrical signals
- A61M2230/10—Electroencephalographic signals
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F2218/00—Aspects of pattern recognition specially adapted for signal processing
- G06F2218/02—Preprocessing
- G06F2218/04—Denoising
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F2218/00—Aspects of pattern recognition specially adapted for signal processing
- G06F2218/08—Feature extraction
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F2218/00—Aspects of pattern recognition specially adapted for signal processing
- G06F2218/12—Classification; Matching
Definitions
- the present invention relates to the field of medical technology, and in particular to a noninvasive acoustic-electric stimulation neuromodulation therapy and a device combining with EEG (electroencephalogram) objective detection and analysis feedback control.
- EEG electroencephalogram
- Cranial nerve dysfunction is a disease of the cranial nervous system that fails to perform its functions normally, which leads to a decrease and/or enhancement of neuronal activity and/or inter-brain cross-effects and/or abnormalities in the regularity of changes.
- Neurological disorders or dysfunctions involve multiple physiological and/or auditory and/or psychological and/or emotional and/or memory and/or attention and consciousness and/or sensory motor brain function areas of objective neuroelectrophysiology ( Neuroelectrophysiology) state, subjective psychological perception and the correlation and cross-action of subjective mental activity, as well as the process conversion of compensation and decompensation of neurological function, are often accompanied by cognitive behavior psychology obstacles, which are traditional problems.
- Neuromodulation therapy is the targeted delivery of stimuli to specific nerve parts of the body, actively stimulating the target area nerves to produce natural biological responses or controlling the physiological levels of neurotransmitters to change nerve activity.
- Tinnitus is the result of different pathological abnormalities and changes in many diseases involving or not affecting the auditory system.
- the etiology is complicated and the mechanism is unclear. It is mainly manifested as no corresponding external sound source or electrical stimulation, but subjectively in the ear or the skull There is a sensation of sound, appearing in one or both ears.
- Tinnitus sounds are mostly continuous or discontinuous, and the volume usually does not exceed the hearing threshold of 20 decibels with varying melody or compound tone or timbre or noise. Tinnitus can cause irritability, anxiety, tension, fear or depression in patients or negative reactions, and bad emotional state can aggravate tinnitus, causing a vicious circle between tinnitus and bad mood.
- the application of sound therapy is relatively wide, such as various tinnitus treatment devices.
- the patent application No. 201810011553.5 discloses a method for fitting hearing aids.
- the biological acoustic stimulation device sends out acoustic stimulation signals to the subject and passes The subject’s response obtains the FPT data; the FPT data is imported into the computer, and the FPT data is corrected for the FPT data based on the preset calibration algorithm through the acoustic test module running in the computer; the biological acoustic stimulation device is connected to the computer After the connection is established, the corrected FPT data is sent to the biological acoustic stimulation device to adjust the acoustic stimulation signal sent to the subject through the DSP chip in the biological acoustic stimulation device to a comfortable state for the subject.
- the subjective feelings of the examinee are used to evaluate the treatment effect;
- the utility model patent with application number 201420311215.0 discloses an electroacoustic stimulator for the treatment of tinnitus, which uses a computer to store electrical impulse parameters for the treatment of tinnitus, and can generate electric pulses of different waveforms according to the mode selected by the patient. Pulse, and output electrical stimulation through an invasive electroacupuncture stimulation device to treat tinnitus, and evaluate the treatment effect through the subjective feelings of the patient;
- the patent application with application number 201910861100.6 discloses a tinnitus and deafness detection and treatment system based on a shared cloud computing platform, including: an online cloud computing platform and multiple offline smart terminals, the cloud computing platform includes the cloud A server and a hearing aid fitting programmer module connected therewith.
- the cloud server is provided with expert or intelligent robot remote technical support, operation and supervision module, big data module, hearing test module, fitting programming software module, tinnitus physiological acoustics Detection and personalized sound treatment program production module and tinnitus sound treatment and cognitive behavioral psychotherapy program library module.
- a personalized tinnitus sound treatment plan and a cognitive behavioral psychotherapy plan are formulated, and the tinnitus treatment is performed, and the treatment effect is still evaluated based on the subjective feeling of the patient.
- Cerebral nerve physiotherapy or non-invasive neuromodulation therapy is currently an important, safe and effective physical therapy method for the treatment of neurological dysfunction.
- the physical factors used include but are not limited to sound, light, electricity, magnetism, nuclear radiation, heat, cold, etc.
- the current detection and treatment evaluation of neurological dysfunction are subjective.
- the market needs a diagnosis, treatment, and evaluation technology based on objective detection of neuromodulation, and a comprehensive system of diagnosis and treatment methods that strengthen objective physiology, subjective psychology, and subjective mind.
- the main technical problem to be solved by the present invention is to provide a method and device for neuroregulation of acoustic and electrical stimulation combined with EEG detection, analysis and feedback control, so as to improve the objectivity, quantification, visualization, standardization and intelligence of the diagnosis and treatment process and the evaluation of treatment effects, and feedback And guide qualitative and quantitative adjustments and optimization of diagnosis and treatment plan and plan parameters to achieve the expected diagnosis and treatment effect, realize the objective and quantitative evaluation of treatment effect and predict the development trend of multi-course treatment.
- a technical solution adopted by the present invention is to provide a non-invasive neuromodulation method combined with EEG objective detection and analysis feedback control of brain electricity, including:
- EEG characteristic parameters include EEG power spectra (PSD, power spectra density), brain Electrical neural network spatial topology (neurological network special topology) and related network statistics attribute parameters and evaluation indicators;
- EEG characteristic parameters feedback and guide the formulation of multiple treatment courses or multiple neuromodulation treatment effects tracking evaluation and prediction methods, qualitatively and quantitatively regulate and optimize the follow-up treatment plan implementation and plan parameter selection according to the expected treatment effect Methods: Based on the objective analysis feedback of physical examination or screening or monitoring of EEG characteristic parameters, establish an association model between EEG characteristic parameters and neurological function status, qualitatively and quantitatively assess and predict neurological function status, and provide early warning;
- the onset of neurological dysfunction in patients involves multiple brain functional areas of physiology and/or hearing and/or psychology and/or emotion and/or memory and/or attention and consciousness and/or sensorimotor
- the relevant EEG signals will change, corresponding to the remodeling of the brain neural network. of brain neural network). Therefore, by collecting EEG signals corresponding to the cortex of multiple brain functional areas, extracting the corresponding EEG spatio-temporal and network characteristics, and performing decoding analysis, the diseases of patients with neurological dysfunction can be objectively, qualitatively and quantitatively evaluated and predicted.
- EEG signals can be obtained by placing a total of not less than 2 leads of dry or wet brain electrode arrays in the main brain function areas.
- the electrode signal transmission and amplifier signal acquisition parameters are: sampling number not less than 10bits, input impedance It should reach the G ⁇ level, the equivalent minimum input noise should not be greater than 10 ⁇ V, the data transmission rate should not be less than 1Mbps, and the signal amplitude range should not exceed 200 ⁇ V.
- the component information related to neural function regulation is obtained from the originally recorded EEG signal, and the task-related components are described by eigenvectors, and the machine learning algorithm (machine learning algorithm) is used to describe the task-related components.
- machine learning algorithm machine learning algorithm
- the accuracy of decoding depends on how well the features extracted by the feature algorithm represent related tasks, and how accurately the classification algorithm can distinguish the categories of different tasks.
- EEG signal decoding analysis includes but is not limited to the following steps:
- EEG signal preprocessing through including but not limited to signal filtering, denoising and discarding, removing eye movement and blink artifacts and electromyography artifacts, principal component analysis, signal reconstruction, to obtain high Quality EEG signals, especially including but not limited to delta, theta, alpha, beta and gamma band signals;
- EEG signal feature extraction through analysis including but not limited to EEG network reconstruction and multidimensional discrete wavelet transform (multidimensional discrete wavelet transform) analysis, maximize the extraction of various feature information of EEG signals, and perform them Characteristic analysis provides more, more accurate, comprehensive and comprehensive information for diagnosis and treatment evaluation;
- EEG signal feature recognition and feature parameter classification using, but not limited to, brain neural network topology, EEG spatiotemporal information (including amplitude, energy, etc.) as features, using deep neural networks, long and short-term networks, and support vectors Machine (support vector machine), neural network, etc. carry out feature recognition and classification to obtain EEG characteristic parameters, including but not limited to: converting the brain wave whose signal amplitude changes with time in the brain area where the target EEG electrode is located into EEG power with frequency Changing power spectrum PSD, as well as the network topology and related network properties of EEG obtained through network analysis, including Coh-network coherence, Clu-clustering coefficient, L-feature path length, Ge-global efficiency and Le-local efficiency, etc.
- EEG characteristic parameters including but not limited to: converting the brain wave whose signal amplitude changes with time in the brain area where the target EEG electrode is located into EEG power with frequency Changing power spectrum PSD, as well as the network topology and related network properties of EEG obtained through network analysis, including Co
- Network statistics through longitudinal comparison of EEG detection and signal decoding analysis of the same state and brain area after multiple treatments, to obtain EEG characteristic parameters with better sensitivity and relevance to the regulation of neurological dysfunction, so as to be more intuitive and feasible. Quantitatively observe and understand the changes in neuronal activity in brain regions and the changes in the correlation of different brain regions, so as to evaluate the effect of treatment and the correlation between abnormal neurological activity in multiple brain regions.
- D. Obtain the results of decoding and analyzing the EEG signals of patients with neurological dysfunction, healthy people, and the same patient through EEG signal decoding and analysis before and/or during and/or after each treatment.
- the same brain area before and after the power spectrum average value PSD and/or the statistical properties and change values of each brain area and the network between the brain areas can be used as a treatment effect evaluation index;
- the acoustic stimulation therapy can be organically linked with electrical impulse therapy and cognitive behavioral psychotherapy to systematically evaluate the therapeutic effect, and the network-related Coh difference reflects the difference in the network space topology between brain regions, that is, the difference in the degree of association activity , Can help evaluate the effects of different treatment plans, and the effects after multiple treatments;
- network coherence and network attributes reflect the overall difference between the same brain area and/or different brain areas, and can better reflect the physical and/or auditory and/or psychological and/or emotional and/or
- the strength of the connection between memory and/or attention and consciousness and/or sensorimotor brain functional areas is the amount of abnormal brain activity changes, which further reveals that tinnitus neurological dysfunction is a synthesis of physiological and cognitive behavioral psychological interactions
- Pathogenesis provides relatively reliable evaluation standard parameters for treatment, and guides the preparation of qualitative and quantitative algorithms for tracking evaluation and prediction of treatment effects, based on the PSD change of the power spectrum, the correlation between the PSD and the frequency corresponding to multiple peaks or troughs of the power spectrum , Network coherence Coh difference and network attributes Clu, Ge, Le and L changes, comprehensively and systematically evaluate the differences in the efficacy of the three treatments of acoustic stimulation, transcranial electrical pulse stimulation and cognitive behavioral psychology, respectively or in combination, and multi-course treatment The effect and progress, or setting treatment goals and
- the neurological dysfunction is the occurrence of cranial nervous system. Inability to perform its functions normally due to pathological changes, resulting in decreased and/or enhanced changes and/or abnormalities in the activity of brain regions and/or cross-effects of brain regions, and corresponding symptoms and signs of neurological damage appear clinically, Including but not limited to tinnitus, deafness, sleep disorders, anxiety, depression, dizziness, ear fullness, ear plugs, neurological headache, mental fatigue, epilepsy, Alzheimer's disease and Parkinson's disease.
- an acoustic-electrical stimulation neuromodulation diagnosis and treatment device combined with EEG detection and analysis feedback control, including but not limited to: EEG detection and signal processing and analysis systems, Intelligent diagnosis and treatment control system, acoustic stimulation treatment system, transcranial electrical impulse stimulation treatment system and cognitive behavioral psychotherapy system.
- the EEG detection and signal processing and analysis system includes but not limited to EEG electrode array module and EEG amplifier module , EEG signal analysis module, EEG equipment control module, display module and power supply module
- the intelligent diagnosis and treatment control system includes but not limited to acoustic signal following EEG signal change control module, electrical pulse signal following EEG signal change control module and
- the cognitive psychotherapy program follows the EEG signal change control module.
- the intelligent diagnosis and treatment control system uses the shared or independent treatment feedback of each control module to qualitatively and quantitatively analyze the intelligent EEG algorithm embedded in the software, and manually or automatically realizes the parameters and parameters of each corresponding treatment plan.
- the acoustic stimulation treatment system includes, but is not limited to, a psychoacoustic testing module, an acoustic stimulation treatment plan production module, an acoustic stimulation treatment module, and an acoustic stimulation treatment display screen module.
- the transcranial electrical pulse stimulation therapy system includes but is not limited to an electrical pulse signal generator module and an electrical pulse therapy electrode array module.
- the cognitive behavioral psychotherapy system includes, but is not limited to, a consultation scale module and a cognitive behavioral psychotherapy module.
- the acoustic and electrical stimulation neuromodulation diagnosis and treatment device combined with EEG detection and analysis feedback control adopts an integrated device or a separate device or a wearable device, and each system module is independent or shared with the display screen and /Or power supply.
- a wearable device including but not limited to wearable brain electricity detection and analysis system, cognitive behavioral psychotherapy system, telemedicine system based on brain electricity analysis feedback, and wired or A wirelessly connected smartphone or tablet computer, write EEG analysis feedback and evaluation into an APP and implant it in the smartphone or tablet computer, which can be used for neurological dysfunction physical examination and/or screening and/or monitoring and/or prediction, making early Early warning, seeking medical advice and/or taking active preventive measures;
- the cognitive behavioral psychotherapy system is implanted in a smartphone or handheld tablet through the APP to guide wearable device users to select and implement cognitive behaviors preset in the APP Psychological training and/or education and/or consultation and/or treatment programs.
- APP will also connect wearable device users and remote experts through wireless networks to provide remote control and/or professional consulting services and carry out two-way communication.
- the physiological acoustic detection of unilateral or bilateral ears is performed through the acoustic stimulation treatment system, including but not limited to hearing, sleep, anxiety, depression, energy concentration test or questionnaire, and multi-channel multi-mode Matching detection and signal processing of state tinnitus sound, plus background natural sound, formulate a multi-channel multi-modal compound acoustic modulation therapy (composite acoustic modulation therapy) with amplitude or phase angle or a mixture of amplitude and phase angle; for non-ear-derived neurological dysfunction , Mainly based on the results of EEG detection and analysis, guide the selection of input parameters and formulate a composite acoustic control plan; the acoustic control plan in the acoustic stimulation treatment plan formulation module, the corresponding electrical signal is converted into a sound wave signal through the earphone in the acoustic stimulation treatment module Input into the ear canal, vibrate the tympanic membrane and the cochlea, drive the inner hair cells
- the direct current or alternating current pulse signal generator module of the transcranial electrical pulse stimulation therapy system sends out electrical pulse signals through the electrical pulse therapy electrode array module placed on the body surface of the relevant brain function area, Releasing electrical pulses to stimulate the cortex or nervous system through the head to achieve the purpose of alleviating the symptoms of neurological dysfunction;
- electrical stimulation treatment parameters include but not limited to pulse frequency, pulse waveform, pulse amplitude, pulse width, pulse delay, start sequence, duration, rest Interval and repetition times; according to EEG objective detection and evaluation of treatment effect, qualitative and quantitative algorithms embedded in the software through intelligent diagnosis and treatment control system, manual or automatic adjustment and optimization of electrical stimulation treatment plan parameters, and formulation of amplitude and/or frequency modulation transcranial electrical stimulation plans , To achieve the purpose of enhancing the treatment effect and speeding up the recovery, or predict the number of treatments or the number of treatment courses required according to the expected treatment effect.
- the cognitive behavioral psychotherapy system formulates a preliminary cognitive behavioral psychological consultation and/or education and/or training plan through the cognitive behavioral psychological inquiry scale, which can be independently or coordinated with the voice Electrical stimulation therapy is performed; according to the objective detection and evaluation of the therapeutic effect of EEG, the qualitative and quantitative algorithm of the intelligent diagnosis and treatment control system is embedded in the software, and the cognitive behavioral psychological treatment plan can be adjusted and optimized manually or automatically, including but not limited to expert consultation, and compilation by experts.
- the beneficial effects of the present invention are: the acoustic and electrical stimulation nerve regulation method and device combined with EEG detection and analysis feedback control proposed by the present invention are different in acoustic stimulation and/or electrical impulse stimulation and/or cognitive behavioral psychotherapy by the human body.
- EEG signal acquisition, EEG signal decoding analysis, and EEG characteristic parameter analysis can be developed to track objective evaluation and prediction methods for multiple treatment courses or multiple treatment effects, and qualitatively and quantitatively adjust and optimize follow-up treatment according to the expected treatment effect
- the method of program implementation and program parameter selection; qualitative and quantitative objective assessment and prediction of neurological function state can be carried out in the physical examination and/or screening and/or monitoring of neurological dysfunction, early warning can be carried out, and the confidence of doctors and patients and the treatment effect can be enhanced.
- Fig. 1 is a schematic structural diagram of a preferred embodiment of an acoustic-electrical stimulation neuromodulation diagnosis and treatment device combined with EEG detection and analysis feedback control according to the present invention
- FIG. 2 is a schematic diagram of the structure of the EEG detection and signal processing and analysis system in Figure 1;
- Figure 3 is a schematic diagram of the structure of the intelligent diagnosis and treatment control system in Figure 1;
- Fig. 4 is a schematic structural diagram of the acoustic stimulation treatment system in Fig. 1;
- Fig. 5 is a schematic diagram of the structure of the transcranial electrical pulse stimulation treatment system in Fig. 1;
- Figure 6 is a schematic diagram of the structure of the cognitive behavioral psychotherapy system in Figure 1;
- Fig. 7 is a schematic diagram showing the location of EEG electrodes in the corresponding brain area when collecting EEG signals
- FIG. 8 is a schematic diagram of the EEG signal analysis technical route or EEG signal decoding approach.
- CNN-Convolutional Neural Network Db6-Six-dimensional Discrete Wavelet
- Figure 9 is a schematic diagram of the technical route of EEG signal preprocessing
- FIG. 10 is a schematic diagram of the big data intelligent detection technology route or EEG signal decoding method for feature recognition and classification.
- CNN convolutional neural network
- LSTM long and short-term memory
- RBM base reduction method
- SVM support vector machine
- KNN K nearest neighbor algorithm
- GPU graphics processing unit
- Figure 11 is a graph showing the difference of the average power spectrum PSD between a healthy person group (lower curve) and a tinnitus patient group (upper curve);
- Figure 12 is a diagram showing the difference in network topology coherence (Coh) between pre and post after acoustic stimulation after multiple acoustic stimulation treatments.
- the functional network connections in the prefrontal area, left temporal lobe, and parietal area are significantly weaker than those in the first post. 1 treatment;
- Figure 13 is the correlation diagram between the changes of Pre network attributes and the treatment effect before acoustic stimulation.
- the network attributes Clu, Ge, and Le decrease with the increase in the number of treatments, and the amount of change and the treatment effect (the reduction in the THI score of the residual tinnitus on the vertical axis means the reduction of tinnitus The degree, the lower, the better) is significantly positively correlated with the edge, the amount of change in L increases with the increase in the number of treatments and is significantly negatively correlated with the treatment effect;
- Figure 14 is a waveform diagram of EEG detection.
- the embodiment of the present invention includes:
- the acoustic and electrical stimulation neuromodulation diagnosis and treatment device combined with EEG detection and analysis feedback control is constructed, including: EEG detection and signal processing and analysis system 2, intelligent diagnosis and treatment control system 1, acoustic stimulation treatment system 4, transcranial
- the electrical impulse stimulation treatment system 3 and the cognitive behavioral psychotherapy system 5 form a closed loop of treatment-detection analysis-treatment control-treatment.
- the acoustic stimulation nerve regulation signal of the acoustic stimulation treatment system 4 stimulates the cochlea through the ear canal to generate electrical stimulation signals, and then enters the brain center and the connected brain functional areas through the auditory nerve pathway to perform deep brain nerve regulation treatment.
- the transcranial electrical impulse stimulation treatment system 3 uses an electrode array placed on the scalp of the relevant brain function area to release electrical impulses through the head to stimulate the cortex and nervous system to implement superficial cerebral nerve regulation and treatment.
- the cognitive behavioral psychotherapy system 5 performs cognitive behavioral psychotherapy through visual reading or video, or listening to counseling or audio through ears.
- the EEG detection and signal processing and analysis system 2 collects EEG signals through an EEG electrode array placed on the scalp, and performs signal analysis and feedback.
- the intelligent diagnosis and treatment control system 1 is connected with the EEG detection and signal processing and analysis system 2, and the EEG analysis result feedback is obtained. According to the embedded algorithm software, the acoustic stimulation treatment system connected to it can be realized separately or uniformly. 4.
- the acoustic electrical stimulation neuromodulation diagnosis and treatment device combined with EEG detection and analysis feedback control can adopt an integrated device, a separate device, or a wearable device, and each system module is independent or sharing a display screen and/or power supply.
- the wearable device includes a wearable EEG detection and analysis system, a cognitive behavioral psychotherapy system 5, a telemedicine system based on EEG analysis and feedback, and a smart phone or tablet computer connected to it by wire or wireless. Take it with you or wear it in combination with clothing.
- EEG analysis feedback and evaluation as an APP and implanting it on a smartphone or handheld tablet, it can be used for neurological dysfunction physical examination and/or screening and/or monitoring and/or prediction, making early warning, seeking medical advice and/ Or take active preventive measures to enjoy mobile and/or telemedicine services without leaving home or anytime, anywhere.
- the cognitive behavioral psychotherapy system 5 is implanted into a smart phone or a handheld tablet through the APP, and guided through the interface, guiding the user to select and implement the cognitive behavioral psychological training and/or education and/or preset in the APP Consultation and/or treatment, or through virtual reality AR/VR means or voice robots.
- APP can also connect wearable users and remote experts through wireless networks, provide remote control and/or professional consulting services, and carry out two-way communication , Realizing online medical treatment is conducive to overcoming the inconvenience, fear, shyness and other problems of patients on-site medical treatment, and there is no need to worry about cross-infection problems.
- the physique and specific conditions of different patients are different, and the use of certain stimuli for diagnosis and treatment cannot be restricted, and trial, feedback and optimization are required. Therefore, the work of the EEG detection and signal processing and analysis system 2, the acoustic stimulation treatment system 4, the transcranial electrical pulse stimulation treatment system 3, and the cognitive behavioral psychotherapy system 5 cannot do without the coordinated control of the intelligent diagnosis and treatment control system 1.
- the intelligent diagnosis and treatment control system 1 as shown in Figure 3 is constructed, including the acoustic signal following the brain electrical signal change control module 11, the electrical pulse signal following the brain electrical signal change control module 12, and the cognitive psychotherapy program follows the brain electrical signal change control module Module 13.
- the intelligent diagnosis and treatment control system 1 uses various modules to communicate with the EEG detection and signal processing and analysis system 2, the acoustic stimulation treatment system 4, the transcranial electrical impulse stimulation treatment system 3 and the cognitive behavioral psychotherapy system 5 to provide feedback and guide optimal treatment Program implementation and program parameter selection, implement predictable stimulation control treatment for patients, and obtain the EEG signal after treatment, and then analyze and process to obtain a new stimulation treatment plan. This loop iteration continuously improves the efficacy and speeds up the treatment.
- the patient's condition including the physical and psychological conditions
- the diagnosis and treatment parameters or plans are required to be adaptable.
- the intelligent EEG algorithm embedded software can be qualitatively and quantitatively analyzed through the shared or independent treatment feedback of each control module, and the adjustment and optimization of each corresponding treatment plan parameter and/or treatment plan usage method can be realized manually or automatically.
- Different patients have different physical conditions and specific symptoms. Therefore, the response to acoustic stimulation, transcranial electrical impulse stimulation or cognitive behavioral psychotherapy is also different.
- transcranial electrical impulse stimulation or cognitive behavioral psychotherapy By trying acoustic stimulation, transcranial electrical impulse stimulation or cognitive behavioral psychotherapy, According to the feedback of EEG signal analysis, guide and determine the most suitable one or more stimulation modes, and modify the parameters of the one or more stimulation modes in real time according to the curative effect, and continuously optimize the treatment plan until the cure.
- an EEG detection and signal processing and analysis system 2 as shown in Figure 2, which includes an EEG electrode array module 23, an EEG amplifier module 25, and a brain
- the electrical signal analysis module 26, the brain electrical equipment control module 22, the display module 24 and the power supply module 21 perform brain electrical detection, signal processing and analysis of the patient.
- EEG detection can help quantify the effect and perform objective evaluation of curative effect, so that the subsequent treatment parameters can be adjusted more accurately, and it is helpful to express the recovery process through percentage or graph.
- the EEG electrode array module 23 includes multiple EEG electrodes.
- the multiple EEG electrodes are placed on the scalp corresponding to the patient’s main brain function area to collect EEG signals.
- the amplifier module 25 is connected for signal input and amplification.
- the power supply module 21 is connected with the brain electrical equipment control module 22 to provide power supply.
- the brain electrical equipment control module 22 is respectively connected with the brain electrical amplifier module 25, the brain electrical signal analysis module 26 and the display module. 24 is connected to conduct EEG space-time modeling and signal analysis and display.
- the EEG signal analysis module 26 communicates with the intelligent diagnosis and treatment control system 1 for information transmission, and feeds back the analysis results to the intelligent diagnosis and treatment control system 1, which is conducive to the intelligent diagnosis and treatment control.
- the system 1 optimally adjusts the follow-up diagnosis and treatment parameters.
- the acoustic stimulation therapy system 4 can be used to perform physiological acoustic detection of unilateral or bilateral ears, including tests or questionnaires such as hearing, sleep, anxiety, depression, energy concentration, and multi-channel multi-modal tinnitus.
- Matching tactus matching, including compound sound, frequency, loudness, pitch, timbre, melody
- signal processing plus background natural sound, formulate a complex acoustic control program of amplitude or phase angle or a mixture of amplitude and phase angle.
- an acoustic stimulation treatment system 4 as shown in FIG. 4 is constructed, including a physiological acoustic detection module 41, an acoustic stimulation treatment plan production module 42, an acoustic stimulation treatment module 43, and an acoustic stimulation treatment display screen module 44.
- the physiological acoustic detection module 41 and The acoustic stimulation treatment plan production module 42 is connected and provides various parameter information required for the preparation of the plan.
- the acoustic stimulation treatment plan production module 42 respectively inputs the produced acoustic stimulation treatment plan into the acoustic stimulation treatment module 43 for acoustic stimulation treatment.
- the treatment display module 44 displays the process and results of the physiological acoustic detection, the acoustic treatment plan and parameters in real time, qualitatively, quantitatively, and visually, and controls the acoustic stimulation treatment system under the guidance of the acoustic signal following the brain electrical signal change control module 11 4 Each module works.
- pre-selection of acoustic stimulation neuromodulation treatment plans and their parameters are mainly based on EEG detection and analysis feedback, and feedback and guidance through the iterative cycle of treatment-EEG detection analysis-treatment control-treatment
- the corresponding electrical signals of the acoustic control plan in the acoustic stimulation treatment plan production module 42 are input to the ear canal through the earphones in the acoustic stimulation treatment module 43, which vibrates the tympanic membrane and the cochlea, drives the inner hair cells of the cochlea to fluctuate and generates electrical stimulation signals.
- the auditory nerve pathway enters the central brain system and the connected brain functional areas such as the thalamus and hippocampus, drives or activates the electrical excitability of neurons and further amplifies the electrical signals, desynchronizes the disordered signals of neural dysfunction, reshapes the neural network, and restores the nerves Normal working condition.
- the adjustable parameters of the acoustic stimulation treatment system 4 include but are not limited to hearing threshold, frequency, amplitude, phase angle, peak sharpening, trough filling, wave delay, knocking gap, background noise and/or natural sound, etc., according to the objective detection of EEG And evaluate the treatment effect, through the intelligent diagnosis and treatment control system 1 qualitative and quantitative algorithm embedded in the software, manually or automatically adjust and optimize the treatment plan and treatment plan parameter selection, it can also enhance the treatment effect and speed up the recovery, and predict the number of treatments or the course of treatment according to the expected treatment effect It is convenient for patients to conduct self-objective assessment and scientifically arrange life, work or study outside of treatment.
- the transcranial electrical pulse stimulation treatment system 3 as shown in FIG. 5 is constructed, which includes an electrical pulse signal generator module 31 and an electrical pulse treatment electrode array module 32.
- the electrical pulse treatment electrode array module 32 includes a plurality of related brain functions.
- the electric pulse treatment electrode of the regional cortex, the electric pulse signal generator module 31 is connected with the electric pulse treatment electrode array module 32, and the amplitude and/or frequency modulation electric pulse is performed under the guidance of the electric pulse signal following the brain electrical signal change control module 12 Treatment plan parameter selection and optimization treatment.
- the electrical pulse signal generator module 31 of the transcranial electrical pulse stimulation treatment system 3 sends electrical pulse signals, and the electrical pulse treatment electrode array module 32 releases electrical pulses to stimulate the intracranial cortical nervous system. To achieve the purpose of relieving or treating the symptoms of neurological dysfunction.
- the parameters of the electrical stimulation treatment plan are not static and vary from person to person. As the treatment progresses or continues, they need to be adjusted continuously.
- the parameters of the electrical stimulation treatment plan include, but are not limited to, pulse frequency, pulse waveform, and pulse amplitude (current and /Or voltage), pulse width, pulse delay, start sequence (used alone or in conjunction with acoustic stimulation therapy), duration, rest interval, number of repetitions, etc., during the treatment process, according to the EEG objective detection and evaluation of the treatment effect feedback , Use the qualitative and quantitative algorithm embedded in the intelligent diagnosis and treatment control system 1 to embed the software to formulate electric pulse stimulation schemes including but not limited to amplitude modulation and/or frequency modulation, and manually or automatically adjust and optimize the parameters of the electric stimulation treatment scheme to enhance the treatment effect and speed up recovery , According to the expected treatment effect and the actual treatment effect, objectively predict the number of subsequent treatments or the number of treatment courses, and even generate multiple combinations and options of the parameters of the electrical stimulation treatment plan and the number of treatment courses according to the patient’s acceptance
- a cognitive behavioral psychotherapy system 5 as shown in FIG. 6 is constructed, which includes an inquiry scale module 52, a cognitive behavioral psychotherapy module 53 and a cognitive behavioral psychotherapy display screen module 51.
- the inquiry scale module 52 and The cognitive behavioral psychotherapy module 53 is connected for information input, and the questionnaire module 52 and the cognitive behavioral psychotherapy module 53 are respectively connected with the cognitive behavioral psychotherapy display screen module 51 to display information and plans.
- the cognitive behavioral psychotherapy system 5 uses the cognitive behavioral psychological questioning scale to formulate a preliminary cognitive behavioral psychological consultation and/or education and/or training plan, which can be carried out independently or in conjunction with acoustic and electrical stimulation therapy. , Adjust or integrate the treatment plan;
- the intelligent diagnosis and treatment control system 1 is used to embed the software with qualitative and quantitative algorithms to manually or automatically adjust and optimize the cognitive behavioral psychotherapy program, such as selecting experts to prepare and store it in the cognitive behavioral psychotherapy module Expert consultation in 53 Miles, through reading graphic materials and/or audio materials and/or video materials and other training and/or education, or virtual reality AR/VR and voice robots, enhance the treatment effect and speed up recovery;
- a non-invasive neuromodulation diagnosis and treatment and/or neurological dysfunction screening prediction method combined with EEG objective detection and analysis feedback control is provided, which specifically includes the following contents:
- Transcranial electrical impulse stimulation and cognitive psychotherapy can be made through qualitative and quantitative judgments or attempts to make a single choice or a combination of treatment options and their parameter selection.
- the EEG signal can be obtained by placing dry or wet EEG electrode arrays on the scalp (including but not limited to the frontal area, the parietal area, and the temporal lobe area) in the main brain functional areas (as shown in Figure 7).
- Electrode signal transmission and amplifier signal acquisition parameters are: the number of sampling bits should not be less than 10bits, the input impedance should reach G ⁇ , the equivalent minimum input noise should not be greater than 10 ⁇ V, the data transmission rate should not be less than 1Mbps, and the signal amplitude range should not exceed 200 ⁇ V.
- the brain network can be used to describe the connections between multiple brain regions.
- 21 EEG electrodes are selected to avoid the volume effect.
- Network coherence is one of the most common methods for measuring the strength of interaction between network nodes. Yu represents the linear relationship between two different signals in a specific frequency domain.
- C xy (f) is the network coherence of X signal and Y signal at frequency point f
- P xy (f) is the cross spectrum of X signal and Y signal
- P xx (f) and P yy ( f) is the self spectrum of the corresponding signal.
- the difference between the coherent C xy (f) m in the m- th treatment state and the coherent C xy (f) n in the n-th treatment state is emphasized by the treatment effect The resulting changes in neural activity or differences in network space topology.
- Network attributes are used to quantitatively measure brain networks:
- C ij is the coherence between the network topology electrodes i and j electrode (Coherence) value; T is the total number of electrodes; d ij is the path length from node j to node i, Clu- clustering coefficient; L-path length; Ge- Global efficiency; Le-local efficiency.
- the onset of neurological dysfunction in patients involves multiple brain functional areas and the interaction between multiple brain functional areas.
- interventions such as acoustic stimulation, transcranial electrical impulse stimulation, or cognitive psychotherapy
- relevant brain electrical signals will be affected.
- the corresponding brain neural network reshapes changes.
- real-time EEG spatiotemporal modeling, extraction of the corresponding EEG spatiotemporal and network characteristics, and decoding and analysis it can be discarded Subjective judgment, and objectively qualitatively and quantitatively evaluate and predict the disease of patients with neurological dysfunction.
- the EEG characteristic parameters related to the treatment effect and the number of treatments and the acoustic electrical stimulation treatment parameters and/or the cognitive behavioral psychotherapy method can be obtained, which is conducive to the establishment and efficacy evaluation
- the associated model of the system realizes the closed loop of detection, analysis, feedback and treatment regulation.
- the EEG characteristic parameters include EEG power spectrum, EEG neural network spatial topology, relevant network statistical attribute parameters and evaluation indicators. Knowing the EEG characteristic parameters will help predict the number of treatments required according to the expected treatment effect.
- the original record of EEG signals contains information related to and irrelevant to the regulation of neurological function.
- the task-related components can be described by feature vectors. , Using machine learning algorithms to classify feature vectors related to different tasks, to decode different brain activity states from EEG signals, and obtain clinical indicators related to the patient’s neurological dysfunction (such as the tinnitus disability scale, sleep scale, anxiety scale , Depression Scale, etc.) closely related EEG components, discarding irrelevant EEG components;
- the accuracy of decoding depends on how well the features extracted by the feature algorithm can represent related tasks, and how accurately the classification algorithm can distinguish different task categories. The higher the decoding accuracy, the better the evaluation of the patient’s disease diagnosis and treatment effect. objective.
- the EEG signal decoding analysis is mainly divided into the following steps:
- EEG signal preprocessing As shown in Figure 9, through signal filtering, denoising and discarding, removal of artifacts such as ocular and EMG, principal component analysis, signal reconstruction, etc., high-quality EEG signals are obtained, especially Including delta (0-4Hz, deep sleep), theta (4-8Hz, light sleep), alpha (8-13Hz, closed eyes to relax completely), beta (14-30Hz, closed eyes to concentrate on thinking) and gamma (31Hz and Above, the signals in the bands such as excitement are as shown in FIG. 14. Calculating and analyzing the EEG signal in the time domain and frequency domain after subtracting the reference electrode signal from the electrode signal of different regions can parse some useful and root information and remove some useless information;
- EEG signal feature extraction Through analysis of EEG network reconstruction and multi-dimensional discrete wavelet transform, various feature information of EEG signals are extracted to the maximum, and feature analysis is performed to ensure the objectivity of diagnosis and treatment effect evaluation And accuracy;
- EEG signal feature recognition and feature parameter classification As shown in Figure 10, brain neural network topology, EEG spatiotemporal information (including amplitude, energy, etc.) can be used as features, and deep neural networks, long and short-term networks, support Vector machine, neural network, etc. carry out feature recognition and classification to obtain EEG characteristic parameters. Through longitudinal comparison of EEG detection and signal decoding analysis of the same state and brain area after multiple treatments, a better sensitivity to neurological dysfunction regulation is obtained. And related EEG characteristic parameters, so as to more intuitively and quantify the observation and understanding of the changes in brain area nerve activity and the changes in the correlation degree of different brain areas, and establish an association model with the evaluation of curative effect, so as to evaluate the treatment effect and multiple brain areas The relationship between abnormal activity of nerves;
- EEG characteristic parameters Through the above-mentioned objective analysis of EEG characteristic parameters, it can feed back and guide the formulation of tracking evaluation and prediction methods for multiple treatment courses or multiple treatment effects, as well as methods for qualitatively and quantitatively adjusting and optimizing subsequent treatment plan implementation and plan parameters according to expected treatment effects Based on the objective analysis of physical examination and/or screening and/or monitoring of EEG characteristic parameters, establish an association model between EEG characteristic parameters and neurological function status, qualitatively and quantitatively assess and predict neurological function status, and provide early warning.
- the neurological dysfunction patients and healthy people, as well as the same patient, obtained from the same brain area before and/or during and/or after each treatment, before and after multiple treatments, are obtained through EEG signal decoding and analysis feedback.
- the EEG signal decoding analysis result is used as an indicator of the treatment effect.
- the power spectrum PSD value and characteristic value of the patient and the healthy person are compared in the relevant frequency or the entire frequency range.
- the power spectrum PSD change amount and the number of treatments of the same patient increase or the treatment effect Improved correlation evaluation, and abnormal brain activity reflected by one or more frequencies corresponding to the peak or trough of the power general wave.
- the larger the power spectrum value the more obvious the change in the abnormal neural activity of the corresponding brain area, that is, the treatment of neurological dysfunction The more significant the effect.
- the neural network combines acoustic stimulation therapy (such as the temporal lobe) with electrical impulse therapy (such as the parietal lobe) and cognitive behavioral psychotherapy (such as the frontal lobe) ) Is organically linked to evaluate the treatment effect, and the network-related Coh differences reflect the differences in the network space topology between brain regions, as shown in Figure 12, that is, the difference in the degree of association activity, which can help evaluate the effects of different treatment options, and The effect after multiple treatments.
- acoustic stimulation therapy such as the temporal lobe
- electrical impulse therapy such as the parietal lobe
- cognitive behavioral psychotherapy such as the frontal lobe
- network coherence and network attributes reflect the overall difference between the same brain area and/or different brain areas, and can better reflect the various physical and/or auditory and/or psychological and/or emotional and/or Or memory and/or attention and consciousness and/or sensory motor brain function of the connection strength, that is, the amount of abnormal brain activity changes, further revealing that tinnitus and other neurological dysfunction is a comprehensive pathogenesis, providing treatment Relatively reliable standard parameters, and then guide the preparation of qualitative and quantitative algorithms for tracking evaluation and prediction of treatment effects.
- the system evaluates the differences in efficacy, multi-course treatment effects and progress of three treatment options, acoustic stimulation, transcranial electrical pulse stimulation, and cognitive behavioral psychology, alone or in combination, or sets treatment goals and evaluation criteria, and predicts the number of treatment courses or the number of treatments required.
- neural network computer numerical simulation modeling and analysis functional magnetic imaging fMRI and animal experiments to assist and verify the neural activity and its changes in brain functional areas before and after the neuromodulation treatment of acoustic and electrical stimulation, and the evaluation of curative effect.
- Test comparison group variable W: 1. Healthy people vs. tinnitus patients; 2. Patients vs. patients themselves.
- Test status variable X: 1. pre, test EEG before treatment; 2. in, test EEG during treatment; 3. post, test EEG after treatment.
- EEG characteristic parameters S of the variable Y of the brain area (electrode node) (the difference in energy and the remodeling of the neural network between the brain areas): 1. The average power spectrum PSD, as shown in Figure 11; 2. Neural network coherence Coh and average neural network topological attribute indicators, as shown in Figures 12 and 13, (such as Clu-clustering coefficient; L-feature path length; Ge-global efficiency; Le-local efficiency);
- EEG band variable Z, including: 1. delta band; 2. theta band; 3. alpha band; 4. beta band; 5. gamma band.
- Nerve control acoustic and electrical stimulation treatment parameter preset and effect evaluation (unilateral or bilateral ears)
- psychoacoustic testing including but not limited to hearing, sleep, anxiety, depression, energy concentration
- multi-channel multi-modal tinnitus sound matching detection and signal processing formulate the amplitude or phase angle or the mixed amplitude and phase angle
- Compound acoustic control plan for non-ear-derived neurological dysfunction
- the results of EEG detection and analysis are mainly used to guide the selection and formulation of the parameters of the compound acoustic control plan
- EEG characteristic parameter difference ⁇ S 1 (W, X, Y, Z), increase or decrease (related to specific characteristic parameters) conforms to the rules given by existing research results or clinical findings;
- the patient includes both physiological and cognitive psychology.
- the change of the tinnitus disability scale THI assessment score is used to indicate the change of the treatment effect; the neural network computer numerical simulation modeling and analysis, and the functional magnetic imaging fMRI , Animal experiments and other means for auxiliary verification.
- the implementation parameters of the acoustic electrical stimulation treatment plan are preferred: including but not limited to treatment duration, rest interval, and number of repetitions;
- the treatment effect evaluation criteria include setting the comparison group W, test state X, test brain area Y, and EEG band Z separately or in combination, with average power spectrum PSD, neural network coherence Coh, and average neural network topology attribute indicators including But not limited to Clu-clustering coefficient, L-feature path length, Ge-global efficiency, Le-local efficiency and other EEG characteristic parameters S n (W, X, Y, Z), and evaluation standard parameters A (W ,X,Y,Z), B(W,X,Y,Z) and C(W,X,Y,Z)
- the present invention points out a method and device for acoustic and electrical stimulation nerve regulation combined with EEG detection and analysis feedback control.
- the feedback is analyzed based on EEG objective detection results.
- it is qualitatively and quantitatively guided to select treatment options and Program parameters, realize the selection of treatment programs such as acoustic stimulation, transcranial electrical pulse stimulation, cognitive behavioral psychology, etc. or optimize the adjustment and optimization of the parameters of the combined treatment program.
- the number of treatment courses or the number of treatments can be designed and/or predicted , Neurological dysfunction physical examination and/or screening and/or monitoring and/or prediction can be performed, and according to the difference or change of the above-mentioned neurological function state relative to the healthy state, it can achieve early warning of neurological dysfunction to see a doctor or take preventive measures in time.
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Abstract
La présente invention concerne un procédé et un appareil de neuromodulation par stimulation acoustique-électrique non invasive combinant un test, une analyse, une rétroaction et un contrôle objectifs d'électroencéphalogramme. L'appareil comprend : un système de test, de traitement de signaux et d'analyse d'électroencéphalogramme (2), un système intelligent de contrôle de thérapie et de diagnostic (1), un système de thérapie par stimulation acoustique (4), un système de thérapie par stimulation par impulsions électriques transcrâniennes (3) et un système de psychothérapie de comportement cognitif (5). Un test d'électroencéphalogramme d'une pluralité de régions fonctionnelles cérébrales d'un corps humain est effectué avant, pendant et après une stimulation acoustique non invasive et/ou une stimulation par impulsions électriques et/ou une psychothérapie cognitive ; et un modèle de corrélation comprenant une évaluation d'un effet thérapeutique est établi au moyen de la collecte de signaux d'électroencéphalogramme, d'une modélisation spatio-temporelle d'électroencéphalogramme en temps réel et d'une analyse objective de paramètres caractéristiques d'un réseau neuronal, ce qui permet de réaliser une boucle fermée de test, d'analyse, de rétroaction, de thérapie et de modulation. Selon le procédé et l'appareil, un procédé de suivi, d'évaluation et de prédiction objectives pour les effets d'une thérapie de neuromodulation sur de multiples couches ou de multiples sessions peuvent être formés, et en fonction des effets thérapeutiques attendus, un procédé ultérieur de mise en œuvre d'un programme thérapeutique et de sélection de paramètres est modulé qualitativement et quantitativement et optimisé, et un état de la fonction neurologique peut être évalué et prédit objectivement.
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