Electrical stimulation system and method for promoting arousal in rehabilitation of impaired consciousness

Abstract

This application provides an electrical stimulation system and method for promoting arousal in the rehabilitation of patients with impaired consciousness. The system comprises a program control module for setting combinations of multiple stimulation points and combinations of multiple stimulation parameters; an implantable spinal cord stimulation module that outputs stimulation signals sequentially according to the combinations of multiple stimulation points and multiple stimulation parameters; a collection module for collecting electroencephalogram (EEG) and electromyogram (EMG) signals when the stimulation signals act on a patient with impaired consciousness; and a processing module that processes the EEG and EMG signals to obtain biometric indicators and determines the optimal combination of stimulation points and optimal combination of stimulation parameters from the combinations of multiple stimulation points and multiple stimulation parameters based on the biometric indicators. The present invention improves the efficiency of promoting arousal by obtaining the optimal combination of electrical stimulation electrode points and electrical stimulation parameters through calculations performed by the processing module using an external EEG and EMG sampling device and an implanted spinal cord electrical stimulator in the human body.

Description

Technical Field

[0001] The present application relates to the field of medical equipment, and specifically to an arousal-promoting electrical stimulation system and method for rehabilitation of consciousness disorders. Background Art

[0002] Prolonged disorders of consciousness (pDoC) refers to a pathological state of consciousness loss lasting more than 28 days caused by various brain injuries such as brain trauma, stroke, and ischemic hypoxic encephalopathy, and is classified into vegetative state (VS) / unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS). Patients with pDoC suffer from severe nervous system damage, accompanied by complex functional impairments and complications, and have long rehabilitation cycles and great difficulties. Therefore, rehabilitation is important throughout the entire treatment cycle for pDoC patients and faces great challenges.

[0003] Currently, for groups with consciousness disorders, there are clinically various treatment methods including non-invasive sensory stimulation, non-invasive electrical stimulation, implantable spinal cord electrical stimulation, implantable brain pacemaker stimulation and other methods, and certain progress has been made in effective treatment methods for different groups with consciousness disorders. In particular, implantable electrical stimulation therapy that has emerged in recent years is in direct contact with the central nervous system, so it can directly stimulate the nervous system of patients with consciousness disorders more accurately.

[0004] However, since patients with consciousness disorders lack effective feedback capabilities, it is impossible to know whether stimulation points, stimulation modes and stimulation parameters, etc. in the medical process are effective for the patients. Therefore, determining effective stimulation points, stimulation modes and stimulation parameters through which means and methods is particularly important throughout the treatment process, and such means are currently lacking in clinical practice. Summary of the Invention

[0005] In light of this, this application submits an awakening promotion system for the rehabilitation of impaired consciousness.

[0006] A program control module that sets multiple combinations of stimulation points, distinguishing at least one of the following: number of points, site of action, and polarity; and multiple combinations of stimulation parameters, including at least one parameter among stimulation amplitude, stimulation frequency, and pulse width, where different combinations of stimulation parameters differ by at least one parameter value.

[0007] An implantable spinal cord stimulation module that sequentially outputs stimulation signals according to the combination of the plurality of stimulation points and the combination of the plurality of stimulation parameters,

[0008] A collection module for collecting electroencephalogram (EEG) and electromyogram (EMG) signals when the aforementioned stimulus signal acts on a patient with impaired consciousness,

[0009] The system includes a processing module that processes the electroencephalogram (EEG) signal and the electromyogram (EMG) signal to obtain biometric indicators, and determines the optimal combination of stimulation points and the optimal combination of stimulation parameters from the combination of the plurality of stimulation points and the plurality of stimulation parameters based on the biometric indicators.

[0010] According to the awakening promotion system for rehabilitation of impaired consciousness provided in this invention, an external electroencephalogram (EEG) and electromyogram (EMG) sampling device and a spinal cord electrical stimulator implanted in the human body work together to form a closed-loop system. Real-time EEG and EMG information collection and calculation in the closed-loop system obtain the optimal combination of electrical stimulation electrode points and electrical stimulation parameters. This system can identify the most effective stimulation points and parameters for the patient using objective physical indicators, does not require the patient's subjective response, can be applied to groups with impaired consciousness, and improves the efficiency of awakening promotion.

[0011] This application provides a method for determining an arousal-promoting electrical stimulation scheme for the rehabilitation of impaired consciousness.

[0012] In the process in which an implantable spinal cord stimulator employs pre-set stimulation parameters and sequentially passes through combinations of multiple stimulation points, each outputting a stimulation signal, the brainwave and electromyogram signals of the human body are collected.

[0013] To calculate biometric indicators for the electroencephalogram (EEG) signals and electromyogram (EMG) signals corresponding to each combination of stimulation points,

[0014] Based on the aforementioned biometric indicators, one optimal combination of stimulation points is determined from the multiple combinations of stimulation points.

[0015] In the process by which an implantable spinal cord stimulator passes through the optimal combination of stimulation points and sequentially adopts multiple combinations of stimulation parameters to output stimulation signals, the brainwave and electromyogram signals of the human body are collected.

[0016] To calculate biometric indicators for the electroencephalogram (EEG) signals and electromyogram (EMG) signals corresponding to each combination of stimulation parameters,

[0017] This includes determining one optimal combination of stimulation parameters from the multiple combinations of stimulation parameters based on the aforementioned biometric indicators.

[0018] According to the method for determining an electrical stimulation scheme provided by the embodiment of this application, first, with the stimulation parameters fixed, an electrical stimulation signal is output by passing through different combinations of stimulation points to collect the patient's physical indicators and identify their response to different points, thereby determining the most effective stimulation points for promoting arousal. Next, the currently determined optimal combination of stimulation points is locked, and a stimulation signal is output using different stimulation parameters to collect the patient's physical indicators again and identify their response to different stimulation parameters, thereby determining the most effective arousal stimulation parameters. Since it is possible to identify the most effective stimulation points and stimulation parameters for the patient using only objective physical indicators through a finite number of polling steps in two stages, this scheme does not require the patient's subjective response and can be applied to groups with impaired consciousness. [Brief explanation of the drawing]

[0019] To more clearly illustrate the embodiments of this application or the prior art, the drawings used in the description of the embodiments of this application or the prior art are briefly described below. Clearly, the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained from these drawings without inventive effort by those skilled in the art.

[0020] [Figure 1] This is a schematic diagram of the configuration of the awakening promotion system provided in the embodiment of this application. [Figure 2] This is a schematic diagram of a front view of the arousal-promoting system provided in the embodiment of this application. [Figure 3] This is a schematic diagram of a side view of the arousal-promoting system provided in the embodiment of this application. [Figure 4] This is a schematic diagram showing the operation flow of the awakening-promoting system provided in the embodiment of this application. [Figure 5] This is a flowchart illustrating the method for determining the arousal-promoting electrical stimulation scheme in the embodiments of this application. [Figure 6]It is a flow chart of the method for determining a second awakening-promoting electrical stimulation方案 in the embodiments of the present application. [Figure 7] It is a flow chart of the method for determining a third awakening-promoting electrical stimulation方案 in the embodiments of the present application. [Figure 8] It is a flow chart of the method for determining a fourth awakening-promoting electrical stimulation方案 in the embodiments of the present application. MODE FOR CARRYING OUT THE INVENTION

[0021] Hereinafter, the technical solution of the present application will be clearly and completely described with reference to the accompanying drawings. It is obvious that the described embodiments are some, but not all, of the embodiments of the present application. All other embodiments obtained by those skilled in the art based on the embodiments of the present application without inventive effort are within the scope of the present application.

[0022] Technical features according to different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0023] As shown in Figure 1, one embodiment of the present application provides an awakening promotion system for rehabilitation of consciousness disorders, which includes an acquisition module 1, a processing module 2, a program control module 3, and an implantable spinal cord stimulation module 4.

[0024] The program control module 3 sets a plurality of combinations of stimulation points and a plurality of combinations of stimulation parameters. Combinations of a plurality of stimulation points are distinguished by at least one of the number of points, action site, and polarity. The stimulation parameters include at least one parameter selected from stimulation amplitude, stimulation frequency, and pulse width, and different combinations of stimulation parameters are distinguished in that the values of at least one parameter are different.

[0025] The implantable spinal cord stimulation module 4 sequentially outputs stimulation signals according to the plurality of combinations of stimulation points and the plurality of combinations of stimulation parameters.

[0026] Collection module 1 collects electroencephalogram (EEG) and electromyogram (EMG) signals when a stimulus signal acts on a patient with impaired consciousness.

[0027] Processing module 2 processes electroencephalogram (EEG) and electromyogram (EMG) signals to obtain biometric indicators, and based on these biometric indicators, determines the optimal combination of stimulation points and the optimal combination of stimulation parameters from a selection of multiple stimulation point combinations and multiple stimulation parameter combinations.

[0028] This system receives the patient's electroencephalogram (EEG) and electromyogram (EMG) information, analyzes it, and controls the implantable spinal cord stimulator to adjust parameters such as electrode points, electrical stimulation amplitude, electrical stimulation pulse width, and electrical stimulation frequency. The implantable spinal cord stimulator can directly deliver stimulation pulses to the central nervous system through electrodes implanted inside the body, significantly improving the accuracy and efficiency of electrical stimulation. Through the cooperation of an external EEG and EMG sampling device and the implanted spinal cord electrical stimulator, a closed-loop system is formed. Real-time EEG and EMG information collection and calculation within the closed-loop system obtains the optimal combination of electrical stimulation electrode points and electrical stimulation parameters, improving the efficiency of promoting arousal.

[0029] As shown in Figure 3, in a preferred embodiment, the program control module 3 includes a first signal input unit 31, a stimulation point parameter setting unit 32, a stimulation parameter setting unit 33, and a parameter wireless output unit 34.

[0030] The first signal input unit 31 receives several stimulation points and several stimulation parameters.

[0031] The stimulation point parameter setting unit 32 sets several combinations of stimulation points according to several stimulation points.

[0032] The stimulus parameter setting unit 33 sets a combination of multiple stimulus parameters according to several stimulus parameters.

[0033] The parameter wireless output unit 34 outputs combinations of multiple stimulation points and combinations of multiple stimulation parameters to the implantable spinal cord stimulation module.

[0034] The stimulation point parameter setting unit 32 and the stimulation parameter setting unit 33 are both software interfaces, while the parameter wireless output unit 34 is wireless transmission hardware.

[0035] During two polling cycles (once each for points and parameters), the program control module 3 sets combinations of multiple stimulation points and multiple stimulation parameters based on the received stimulation points and parameters, and outputs them to the implantable spinal cord stimulation module 4. Once the two polling cycles are complete, the second signal output unit 24 transmits the optimal combination of stimulation points and optimal combination of stimulation parameters to the first input unit 31 of the program control module 3. Subsequently, the parameter wireless output unit 34 controls the implantable spinal cord stimulation module 4 to automatically perform continuous rehabilitation therapy.

[0036] Several stimulation points and several stimulation parameters received by the first signal input unit 31 are set by the stimulation point parameter setting unit 32 and the stimulation parameter setting unit 33 of the program control module 3 as combinations of multiple stimulation points and combinations of stimulation parameters, selecting stimulation electrodes at different locations on the spinal cord so that the target nerve region is stimulated. The combinations of stimulation parameters relate to parameters such as the intensity, frequency, and pulse width of the stimulation signal, and different combinations of these parameters can produce different stimulation effects. The parameter wireless output unit 34 outputs the combinations of multiple stimulation points and multiple stimulation parameter combinations to the implantable spinal cord stimulation module to achieve different methods of stimulation therapy for the patient.

[0037] In a preferred embodiment, as shown in Figure 3, the implantable spinal cord stimulation module 4 includes an implantable spinal cord stimulator 41, a spinal cord stimulation electrode 42, and a spinal cord electrode lead 43, and the implantable spinal cord stimulation module may be an integrated implantable spinal cord stimulation product in which the implantable spinal cord stimulator, spinal cord stimulation electrode, and spinal cord electrode lead are functionally integrated.

[0038] The implantable spinal cord stimulator 41 receives combinations of multiple stimulation points and combinations of multiple stimulation parameters, and controls the spinal cord stimulation electrode 42 via the spinal cord electrode lead 43 to sequentially output stimulation signals corresponding to the combinations of multiple stimulation points and combinations of multiple stimulation parameters.

[0039] The implantable spinal cord stimulator 41 controls the spinal cord stimulation electrode 42 using the spinal cord electrode lead 43 and outputs stimulation signals sequentially according to a set combination of multiple stimulation points and stimulation parameters.

[0040] The stimulation parameters of the implantable spinal cord stimulator 41 typically include voltage or current (stimulation amplitude), frequency of the stimulation signal output, and waveform (pulse width) of the stimulation signal. The values ​​of the stimulation parameters can be set empirically, and in this step, the preset values ​​of the stimulation parameters are unique and constant. For example, the preset stimulation parameters are a voltage of 2.5V, a frequency of 70Hz, and a waveform of 120μs.

[0041] The spinal cord stimulation electrode 42 has multiple output electrode contacts (points), specifically 16 (more or less), and the combination of stimulation points is one or more of all contacts. For example, the stimulation contact numbers are #1 to #16, where contact #1 and contact #2 can be one stimulation point combination, and contacts #1, #2, and #4 can be another stimulation point combination. These combinations are merely examples to illustrate the meaning of the contact combinations, and in actual applications, different point combinations can be partially the same number, all different numbers, different numbers, or the same number or number but with different time series or polarity contacts. Since individual electrode contacts implanted in the human body act on different body / nerve areas, the effect of the generated stimulation may differ when stimulation signals are output from different points or combinations.

[0042] Stimulation signals are output through these stimulation points with stimulation parameters corresponding to the patient, and these stimulation signals can act directly on spinal nerve fibers. The spinal stimulation electrodes 42 output stimulation signals using different combinations of stimulation points in sequence (contacts not belonging to a combination remain closed and do not output stimulation signals), and the duration of the output stimulation signal is the same for each combination of stimulation points, for example, 15 minutes. On the other hand, the implantable spinal stimulator 41 controls the spinal stimulation electrodes 42 using spinal electrode leads 43, and outputs stimulation signals sequentially with optimal stimulation points and optimal stimulation parameters obtained by calculation. The stimulation is transmitted to the cerebral cortex via the ascending reticular activation system, increasing the brain's local glucose metabolic rate and cerebral blood flow, promoting the release of excitatory neurotransmitters, enhancing conscious impulses and brain electrical activity, thereby promoting the patient's awakening.

[0043] As shown in Figure 2, in a preferred embodiment, the acquisition module 1 comprises an electroencephalogram (EEG) acquisition unit 11, an electromyogram (EMG) acquisition unit 12, and a first signal output unit 13.

[0044] The electroencephalogram (EEG) acquisition unit 11 collects EEG signals via an EEG acquisition cap before the stimulus signal acts and when it acts on a patient with impaired consciousness.

[0045] The electromyography unit 12 collects electromyographic signals via surface electrodes before the stimulus signal acts and when it acts on a patient with impaired consciousness.

[0046] The first signal output unit 13 outputs electroencephalogram (EEG) signals to the processing module via an electrode wire method or a wireless transmission method, and outputs electromyogram (EMG) signals to the processing module wirelessly.

[0047] The electroencephalogram (EEG) acquisition cap includes internal electrodes and a cap support structure. The internal electrodes collect EEG signals, and the cap support structure is used to support the EEG acquisition cap, providing stable and comfortable support and helping to ensure that the internal electrodes fit precisely to the scalp, thereby ensuring the quality and accuracy of the EEG signals.

[0048] The electroencephalogram (EEG) and electromyogram (EMG) signals of patients with impaired consciousness, collected by the EEG acquisition unit 11 and the EMG unit 12 before the stimulation signal acts on them, are output to a processing module, converted into biometric indicators, and compared with the EEG and EMG signals when the stimulation signal acts on the patient with impaired consciousness, as well as the biometric indicators converted by the stimulation signal.

[0049] The wireless transmission method used by the first signal output unit 13 may be Bluetooth® or Wi-Fi, etc.

[0050] The electroencephalogram (EEG) acquisition unit 11 and the electromyogram (EMG) acquisition unit 12 in the acquisition module 1 collect electroencephalogram (EEG) and electromyogram (EMG) signals when a stimulus signal acts on a patient with impaired consciousness using an EEG acquisition cap and body surface electrodes. The number of EMG acquisition points on the body surface electrodes may be 1 to 32. For example, it is possible to place several EMG acquisition electrodes on each of the four limbs, or to place only one EMG acquisition electrode on a particular arm or leg. The system collects the corresponding EEG and EMG signals when a combination of pre-set stimulation points and stimulation parameters acts on the patient, enabling analysis and calculation of the optimal combination of stimulation points and stimulation parameters that acts on the patient.

[0051] The processing module 2 includes a second signal input unit 21, an algorithm determination unit 22, a memory display unit, and a second signal output unit 24.

[0052] The second signal input unit 21 receives electroencephalogram (EEG) signals and electromyogram (EMG) signals.

[0053] The algorithm determination unit 22 converts electroencephalogram (EEG) signals and electromyogram (EMG) signals to obtain biometric indicators, and based on these biometric indicators, compares multiple combinations of stimulation points and multiple combinations of stimulation parameters to determine the optimal combination of stimulation points and the optimal combination of stimulation parameters.

[0054] The memory and display unit stores and displays electroencephalogram (EEG) signals, electromyogram (EMG) signals, biometric indicators converted by the algorithm, the optimal combination of stimulation points, and the optimal combination of stimulation parameters.

[0055] The second signal output unit 24 outputs the optimal combination of stimulation points and the optimal combination of stimulation parameters to the program control module 3.

[0056] In the processing module 2, the algorithm processing and comparison unit, using the algorithm determination unit 22, processes and analyzes the electroencephalogram (EEG) and electromyogram (EMG) signals received by the second signal input unit 21 using a pre-stored built-in algorithm. It extracts key information from the EEG and EMG, obtains the optimal combination of stimulation points and optimal combination of stimulation parameters, and then stores and displays the EEG signal, EMG signal, biometric indicators converted by the algorithm, and the optimal combination of stimulation points and optimal combination of stimulation parameters using the storage and display unit. Finally, the second signal output unit 24 directly outputs the optimal combination of stimulation points and optimal combination of stimulation parameters to the program control module 3 via a wired connection. The stimulator is then automatically configured according to the optimal combination of stimulation points and optimal combination of stimulation parameters, and subsequent continuous stimulation therapy is performed on the patient.

[0057] In a preferred embodiment, the memory display unit includes a display 231 for displaying to the user the collected electroencephalogram (EEG) signals, electromyogram (EMG) signals, converted biometrics, comparison process data, and the compared optimal stimulation point combinations and optimal stimulation parameter combinations, and a memory 232 for storing the collected EEG signals, EMG signals, converted biometrics, and the optimal stimulation point combinations and optimal stimulation parameter combinations.

[0058] The software displays on the user (doctor) the electroencephalogram (EEG) signals, electromyogram (EMG) signals, converted biometric indicators, comparison process data, and the optimal combination of stimulation points and optimal stimulation parameters after comparison. The doctor can refer to the display results shown on the screen, and can also manually set the optimal treatment plan for the patient with impaired consciousness using the stimulation parameter setting unit 33 and the stimulation point parameter setting unit 32 to perform continuous stimulation therapy.

[0059] In a preferred embodiment, the biometrics include brain activity metrics and physical activity metrics, wherein the brain activity metrics include at least one of the following metrics calculated based on electroencephalogram signals: average amplitude, rhythm, ordinal entropy, sequence entropy, information interconnectivity information, and recursive brain interstitial change information, and the physical activity metrics include motion monitoring amplitude values ​​calculated based on electromyogram signals.

[0060] For example, if we denote combinations of multiple stimulation points as combination 1 to combination n, then brain activity index 1 and physical activity index 1 can be calculated from electroencephalogram (EEG) signal 1 and electromyogram (EMG) signal 1 during the process of outputting a stimulation signal with combination 1, and so on, from electroencephalogram (EEG) signal n and EMG signal n during the process of outputting a stimulation signal with combination n, brain activity index n and physical activity index n can be calculated. To simplify the explanation, these are called biometric indicators corresponding to combinations of stimulation points.

[0061] When adopting multiple of the above biometric indicators, the priority or weighting of the corresponding indicators can be set in advance, thereby differentiating how the improvement effects of different types of indicators are handled. For example, each item can be compared according to its weight, or the improvement amount of each indicator and its corresponding weight can be weighted statistically calculated to determine the total improvement effect.

[0062] The goal of this system is to determine the optimal stimulation points and parameters for an implantable spinal cord stimulation module (implantable spinal cord stimulator). First, the system is initialized, and the program control module, based on the settings input by the medical staff, adopts empirical parameters (i.e., several stimulation points and several stimulation parameters) as initialization parameters and sets the stimulation points and parameters of the implantable spinal cord stimulator. For example, an electrical stimulation pulse of 2.5V, 70Hz, and 120μs width is applied to the two central electrodes for a duration of 15 minutes. After the stimulation is administered to the patient, the acquisition module collects electroencephalogram (EEG) and electromyogram (EMG) signals. After completing the stimulation for this electrode combination, the electrode combination (combination of stimulation points and combination of stimulation parameters) is changed. For example, it is changed to the two edge electrodes, and an electrical stimulation pulse of 2.5V, 70Hz, and 120μs width is applied for a duration of 15 minutes. After the stimulation is administered to the patient, the acquisition module collects electroencephalogram (EEG) and EMG signals. The change of electrode combinations and collection of information continues until the polling of the electrode combinations is complete. The processing module uses a data processing algorithm to acquire results of biometric indicators such as average amplitude, rhythm, ordinal entropy, information interoperability information, and recurrence information of brain interstellar changes in electroencephalography (EEG), as well as results of biometric indicators such as motion monitoring amplitude values ​​from electromyography (EMG). By comparing the biometric indicators of each electrode combination, it selects the optimal combination of electrode points and determines the electrode point that provides the best stimulation effect.

[0063] Furthermore, the electrical stimulation parameters are determined. Using fixed electrode points, the amplitude, frequency, and pulse width parameters of the electrical stimulation are scanned, and each combination of parameters is stimulated for 15 minutes, acquiring electroencephalogram (EEG) and electromyogram (EMG) information under different parameter combinations. The processing module uses a data processing algorithm to acquire biometric results such as average amplitude, rhythm, ordinal entropy, information interconnectivity information, and recurrence information of brain interstitial changes for EEG, and biometric results of motion monitoring amplitude values ​​for EMG, to select the optimal electrical stimulation parameters and determine the electrical stimulation parameters that produce the best stimulation effect.

[0064] By combining the optimal stimulation points and parameters, the optimal treatment plan for this patient with impaired consciousness is determined, and subsequent related stimulation therapies are developed. The user (physician) is presented with the combinations of stimulation points and parameters used in this method, as well as the corresponding biometric indicators. The results of the optimal combination determined by this method are displayed, allowing the user (physician) to view all the results and select the appropriate stimulation combination themselves.

[0065] As shown in Figure 4, the operational flow of each module in the arousal promotion system for impaired consciousness is specifically described.

[0066] Collection module 1 begins the collection process and collects electroencephalogram (EEG) and electromyogram (EMG) signals from patients with impaired consciousness that do not emit stimulating signals.

[0067] The program control module 3 receives several stimulation points and several stimulation parameters via the first signal input unit 31, sets combinations of multiple stimulation points via the stimulation point parameter setting unit 32, and sets combinations of multiple stimulation parameters via the stimulation parameter setting unit 33. The set combinations of multiple stimulation points and multiple stimulation parameters are transmitted to the implantable spinal cord stimulation module 4 via the parameter wireless output unit 34. The implantable spinal cord stimulator 41 of the implantable spinal cord stimulation module 4 receives the combinations of multiple stimulation points and multiple stimulation parameters, transmits the combinations of multiple stimulation points and multiple stimulation parameters to the spinal cord stimulation electrodes 42 via the spinal electrode leads 43, and sequentially outputs stimulation signals to the patient's body. When the implantable spinal cord stimulation module 4 outputs stimulation signals to the patient (treatment), the electroencephalogram (EEG) acquisition unit 11 of the acquisition module 1 acquires EEG signals via the EEG acquisition cap when the stimulation signals act on a patient with impaired consciousness. Simultaneously, the electromyography (EMG) acquisition unit 12 collects EMG signals when a stimulus signal acts on a patient with impaired consciousness using surface electrodes. Subsequently, the first signal output unit 13 outputs EEG signals and EMG signals to the processing module 2 via electrode wires or wirelessly (Bluetooth®, WIFI, etc.). The second signal input unit 21 in the processing module 2 receives the EEG signals and EMG signals. The algorithm determination unit converts the EEG signals and EMG signals to obtain biometric indicators. Based on these biometric indicators, it compares and determines the optimal combination of stimulation points and optimal stimulation parameters from multiple combinations of stimulation points and multiple combinations of stimulation parameters. During this process, the memory display unit displays and stores the EEG signals, EMG signals, biometric indicators, comparison process data, and comparison result data (optimal combination of stimulation points and optimal combination of stimulation parameters).

[0068] The memory display unit displays multiple optimal stimulation parameter combinations on the display screen, after which the user (physician) can select based on the displayed optimal stimulation parameter combinations. The second signal output unit 24 and the first signal input unit 31 are turned off, and the stimulation point parameter setting unit 32 and the stimulation parameter setting unit 33 are both manually set by the user (physician). Subsequently, the optimal stimulation point combination and optimal stimulation parameter combination selected by the user (physician) are output to the implantable spinal cord stimulation module 4 via the parameter wireless output unit, and finally the implantable spinal cord stimulation module 4 performs continuous rehabilitation treatment on the patient with impaired consciousness.

[0069] The single optimal combination of stimulation points and optimal stimulation parameters can also be directly output by the second signal output unit 24 to the first input unit 31 of the program control module 3, and the parameter wireless output unit 34 controls the implantable spinal cord stimulation module 4 to automatically perform continuous rehabilitation therapy.

[0070] This system combines an external electroencephalogram (EEG) and electromyogram (EMG) sampling device with an implanted spinal cord electrical stimulator to form a closed-loop system. By collecting and calculating real-time EEG and EMG information within this closed-loop system, the system obtains the optimal combination of electrical stimulation electrode points and electrical stimulation parameters, thereby improving the efficiency of promoting arousal.

[0071] As shown in Figure 5, one embodiment of the present application provides a method for determining an arousal-promoting electrical stimulation scheme for rehabilitation of impaired consciousness, which is performed by the processing module of the system described above.

[0072] In S1, the implantable spinal cord stimulator employs pre-set stimulation parameters and sequentially passes through a combination of multiple stimulation points, outputting stimulation signals from each. During this process, electroencephalogram (EEG) and electromyogram (EMG) signals from the human body are collected.

[0073] The stimulation parameters of an implantable spinal cord stimulator typically include voltage or current (stimulation amplitude), frequency of the stimulation signal output, and waveform (pulse width) of the stimulation signal. The values ​​of the stimulation parameters can be set empirically, and in this step, the preset values ​​of the stimulation parameters are unique and constant. For example, preset stimulation parameters might be a voltage of 2.5V, a frequency of 70Hz, and a waveform of 120μs.

[0074] An implantable spinal cord stimulator has multiple output electrode contacts (points), specifically, 16 (or more or less). In this scheme, the combination of stimulation points is one or more of all contacts. For example, the stimulation contact numbers are #1 to #16, where contacts #1 and #2 can be one stimulation point combination, and contacts #1, #2, and #4 can be another stimulation point combination. These combinations are merely examples to illustrate the meaning of the contact combinations; in actual application, different point combinations can be partially the same number, all different numbers, different numbers, or the same number or number but with different time series or polarity contacts. Since each electrode contact implanted in the human body acts on different body / nerve sites, the effect of the generated stimulation may differ when stimulation signals are output from different points or combinations.

[0075] When the stimulation parameters are constant, the stimulator outputs stimulation signals by sequentially using different combinations of stimulation points (contacts not belonging to a combination remain closed and do not output stimulation signals), and the duration of the output stimulation signal is the same for each combination of stimulation points, for example, 15 minutes. This step involves acquiring electroencephalogram (EEG) and electromyogram (EMG) signals corresponding to these stimulation processes.

[0076] For example, if we denote combinations of multiple stimulation points as combination 1 to combination n, we can collect electroencephalogram (EEG) signal 1 and electromyogram (EMG) signal 1 during the process of outputting a stimulation signal with combination 1, and so on, collecting electroencephalogram (EEG) signal n and EMG signal n during the process of outputting a stimulation signal with combination n. In other words, each combination of stimulation points corresponds to continuous-time EEG and EMG signals.

[0077] The combination of multiple stimulation points may not be all possible combinations, but rather a combination of points that are likely to be effective, determined based on the patient's actual condition and medical experience. This improves the efficiency of the scheme by avoiding performing the stimulation process using points that cannot produce the desired effect.

[0078] There are many options for the location, method, and equipment used to acquire electroencephalogram (EEG) and electromyogram (EMG) signals, and this solution is not limited thereto. In some embodiments, the EEG signal is the EEG signals of multiple brain regions acquired by an EEG cap with multiple acquisition points. The EMG signal is the EMG signal acquired by at least one surface electrode placed on the skin surface of the limbs of the human body, and the number of EMG acquisition points may range from 1 to 32. For example, several EMG acquisition electrodes may be placed on each limb, or only one EMG acquisition electrode may be placed on a particular arm or leg.

[0079] In S2, biometrics are calculated for the electroencephalogram (EEG) and electromyogram (EMG) signals corresponding to each combination of stimulation points. The biometrics calculated by this method can reflect the body's response to the output process of the stimulation signals, and specifically include brain activity indices and physical activity indices. More specifically, brain activity indices include at least one of the following calculated based on the EEG signal: average amplitude, rhythm, ordinal entropy, sequence entropy, information interconnectivity information, and recursive brain interstitial change information. Physical activity indices include motion monitoring amplitude values ​​calculated based on the EMG signal.

[0080] For example, if we denote combinations of multiple stimulation points as combination 1 to combination n, then brain activity index 1 and physical activity index 1 can be calculated from electroencephalogram (EEG) signal 1 and electromyogram (EMG) signal 1 during the process of outputting a stimulation signal for combination 1, and so on, from electroencephalogram (EEG) signal n and EMG signal n during the process of outputting a stimulation signal for combination n, brain activity index n and physical activity index n can be calculated. To simplify the explanation, these are called biometric indicators corresponding to combinations of stimulation points.

[0081] In S3, the optimal combination of stimulation points is determined from multiple combinations of stimulation points based on biometrics. When the stimulation parameters are fixed, the values ​​or states of biometrics generally differ as different combinations of stimulation points produce different stimulation signals. This step may involve selecting one or more combinations of stimulation points from all possible combinations of stimulation points that correspond to the optimal biometrics, or selecting one or more combinations of stimulation points that achieve the desired stimulation effect. There are several possible decision logics, which will be described in detail in the following embodiments.

[0082] Steps S1-S3 determine the combination of stimulation points i that will produce the most positive arousal-promoting effect on the patient, assuming all combinations output stimulation signals separately using the same stimulation parameters.

[0083] In S4, the implantable spinal cord stimulator collects electroencephalogram (EEG) and electromyogram (EMG) signals from the human body as it passes through an optimal combination of stimulation points and sequentially employs multiple combinations of stimulation parameters to output stimulation signals. A combination of stimulation parameters is, for example, a combination of different values ​​such as the amplitude of the stimulation signal, the frequency of the stimulation signal, and the pulse width of the stimulation signal. Each stimulation parameter has a settable range. For example, the stimulation amplitude is 0 to 10V. If there is only one adjustable stimulation parameter, then a combination of that single stimulation parameter consists of different values. For example, in some embodiments, only one parameter, the stimulation frequency, can be changed. Parameter combination 1 is a voltage of 2.5V, a frequency of 70Hz, and a wavewidth of 120μs, while parameter combination 2 is a voltage of 2.5V, a frequency of 140Hz, and a wavewidth of 120μs. The two parameter combinations differ substantially only in the frequency of the stimulation signal.

[0084] When multiple adjustable stimulation parameters exist, the number of possible combinations of stimulation parameters is greater than the number of combinations of stimulation points described above. Therefore, the combinations of multiple stimulation parameters may not be all possible combinations, but rather combinations of stimulation parameters that are likely to be effective, set based on the patient's actual situation and medical experience. This improves the efficiency of this scheme by avoiding performing the stimulation process using parameters that cannot produce the desired effect.

[0085] If the stimulation points (the optimal combination of stimulation points) remain constant, the stimulator outputs stimulation signals by sequentially using different combinations of stimulation parameters (contacts not belonging to a combination remain closed), and the duration of the stimulation signal output for each combination of stimulation parameters is the same, for example, 15 minutes. This step involves acquiring electroencephalogram (EEG) and electromyogram (EMG) signals corresponding to these stimulation processes.

[0086] For example, if we denote a combination of multiple stimulation parameters as parameter 1 to parameter n, we can collect electroencephalogram (EEG) signal 1 and electromyogram (EMG) signal 1 during the process of outputting a stimulation signal using parameter 1, and collect electroencephalogram (EEG) signal n and EMG signal n during the process of outputting a stimulation signal using parameter n.

[0087] In S5, biometric indicators are calculated for the electroencephalogram (EEG) and electromyogram (EMG) signals corresponding to each combination of stimulation parameters. Specifically, step S2 can be referenced, and the same indicators and calculation methods as in that step can be adopted.

[0088] In S6, the optimal combination of stimulation parameters is determined from multiple combinations of stimulation parameters based on the biometrics. When the stimulation point is fixed, the value or state of the biometrics generally differs depending on the action of different combinations of stimulation parameters. This step may involve selecting one or more combinations of stimulation parameters that correspond to the relatively optimal biometrics from all possible combinations of stimulation parameters, or it may involve selecting one or more combinations of stimulation parameters that achieve the desired stimulation effect. There are several possible decision logics, which will be described in detail in the following embodiments.

[0089] Steps S4-S6 determine the combination of parameters j that will produce the most positive arousal-promoting effect on the patient when different combinations of parameters are used to output stimulation signals using the optimal combination of stimulation points. To date, this scheme has determined the combination of stimulation points i and the combination of stimulation parameters j, and the physician can refer to these results to specify the optimal scheme for this patient with impaired consciousness and implement continuous stimulation therapy.

[0090] Specifically, the user (doctor) is presented with combinations of stimulation points and stimulation parameters used in this method, as well as corresponding biometric indicators. The results of the optimal combination determined by this method are displayed, allowing the user (doctor) to view all the results and select the appropriate stimulation combination themselves.

[0091] As shown in Figure 6, in one embodiment, step S3 includes the following operations.

[0092] In S31A, the improvement effect of various biometrics corresponding to each combination of multiple stimulation points is calculated compared to the biometrics before the start of stimulation. For biometrics before the start of stimulation, electroencephalogram (EEG) and electromyogram (EMG) signals for a certain period of time (for example, 15 minutes, the same as the duration of the stimulation signal output by each combination) may be collected before outputting the stimulation signal, and the corresponding biometrics may be calculated. Alternatively, earlier biometrics may be obtained, for example, those collected and calculated when the patient received their previous diagnosis.

[0093] In S32A, the improvement effects corresponding to multiple combinations of stimulation points are compared, and the combination of stimulation points that has the optimal improvement effect is determined as the optimal combination of stimulation points. In this embodiment, the improvement effects of all point combinations are compared with each other, and the point combination with the best improvement effect is obtained.

[0094] If we use the average amplitude as one of the indicators, then if the improvement effect of combination 1 is B1-C1mV, where B1>C1, and the improvement effect of combination 2 is 0mV, then combination 1 is the combination with the relatively better improvement effect. By comparing all combinations in this way, we can determine the combination that has the highest improvement effect.

[0095] Step S6 includes the following actions:

[0096] In S61A, the improvement effect is calculated for various biometric indicators corresponding to combinations of multiple stimulation parameters, compared to the biometric indicators before the start of stimulation. Specifically, refer to S31A, and the calculation method used is the same, but in this step, the improvement effect corresponding to parameter 1... and the improvement effect corresponding to parameter n are calculated.

[0097] In S62A, the improvement effects corresponding to multiple combinations of stimulation parameters are compared, and the combination of stimulation parameters that has the optimal improvement effect is determined as the optimal combination of stimulation parameters. Specifically, refer to S32A, in this embodiment, the improvement effects for all combinations of parameters are compared with each other, and the combination of parameters with the best improvement effect is obtained. By comparing all combinations in this way, the combination of parameters with the highest improvement effect can be determined.

[0098] The above biometric indicators and their corresponding improvement effects further include the following:

[0099] Regarding the average amplitude, the improvement effect is the increase in the average amplitude during stimulation, that is, the difference between the average amplitude during stimulation and the average amplitude before stimulation. A larger difference indicates a better improvement effect.

[0100] Regarding rhythm, the improvement effect is that the continuity of the interval values ​​improves, appearing intermittently before the stimulus begins, and the stimulus process appearing continuously and sustainably.

[0101] Regarding ordinal entropy, the improvement effect is the increase in the ordinal entropy value of each observed region during the stimulation process compared to the ordinal entropy value before stimulation; a larger increase indicates a higher improvement effect.

[0102] Regarding sequence entropy, the improvement effect is the increase in the sequence entropy value of each monitored region during the stimulation process compared to the sequence entropy value before stimulation; a larger increase indicates a higher improvement effect.

[0103] Regarding information interoperability, the improvement effect is measured by a significant increase in the number of activated channels during the stimulation process compared to before stimulation, and by the amount of increase in activity. The greater the increase in the number of activated channels and the greater the increase in activity, the higher the improvement effect.

[0104] Regarding recurrent information on brain interval changes, the improvement effect is measured by the decrease in the brain interval change index value during stimulation compared to the brain interval change index value before stimulation; a larger decrease indicates a better improvement effect.

[0105] Regarding the active motion monitoring amplitude value, the improvement effect is measured by the increase in the active motion monitoring amplitude value during the stimulation process, that is, the difference between the active motion monitoring amplitude value during the stimulation process and the active motion monitoring amplitude value before the start of stimulation (the active motion monitoring amplitude value for patients with impaired consciousness is 0). A larger difference indicates a better improvement effect.

[0106] Based on the improvement effect of each indicator, the total improvement effect of all indicators can be calculated comprehensively.

[0107] In steps S3 and S6 above, when multiple of the above biometric indicators are adopted, corresponding priorities or weights can be set in advance, thereby differentiating the treatment of improvement effects of different types of indicators. For example, the improvement effects of multiple biometric indicators can be compared for each item according to the weights, or the improvement amount of each indicator and its corresponding weight can be weighted statistically to calculate a numerical value and represent the total improvement effect. By simultaneously employing the above two methods, the improvement effects of multiple biometric indicators for each item are compared, and the total improvement effect is calculated and compared, and the optimal combination of points and the optimal combination of parameters are determined according to the results of the two comparisons.

[0108] In some embodiments, in addition to the four biometric indicators of average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information, more brain indicators than those mentioned above are used. In these embodiments, when comparing each item in the improvement effect comparison operation in steps S31A-S32A and S61A-S62A, the four indicators of average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information are given priority in the comparison, and the optimal point combination i and optimal parameter combination j are given the relatively highest average amplitude increase, array entropy increase, active motion monitoring amplitude value increase, information interoperability information increase, and increased number of active channels. By adopting a method for calculating the total improvement effect, higher weights can be set for these four indicators, and the calculation results will be more heavily influenced by the improvement amounts of these four indicators.

[0109] When actually applying this to a real-world scenario, the user can be presented with comparative results. The optimal combination can be presented in an array format, with the best combinations appearing first based on the degree of improvement. All stimulus combinations can be ranked and presented, or only the optimal single set or the first few sets can be presented for the user (doctor) to consider before making a selection.

[0110] As shown in Figure 7, in one embodiment, step S3 includes the following operations.

[0111] In S31B, the improvement effect is calculated for each biometric indicator corresponding to a combination of multiple stimulation points, compared to the biometric indicator before the start of stimulation.

[0112] In S32B, the improvement effect is compared with the expected effect, and the combination of stimulation points in which the improvement effect is higher than the expected effect is determined as the optimal combination of stimulation points. This embodiment differs from the previous embodiment in that the passing conditions for the improvement effect of various biological indicators are set in advance. This step determines whether the passing conditions have been met for each combination of points, corresponding to the biological indicator and its improvement effect, and then obtains the optimal combination of stimulation points.

[0113] Step S6 includes the following actions:

[0114] In S61B, the improvement effect is calculated for each biometric indicator corresponding to a combination of multiple stimulation parameters, compared to the biometric indicator before the start of stimulation.

[0115] In S62B, the improvement effect is compared with the expected effect, and the combination of stimulation parameters in which the improvement effect is higher than the expected effect is determined as the optimal combination of stimulation parameters.

[0116] For example, the expected effects (passing conditions) for improving various biological indicators are as follows:

[0117] Regarding the average amplitude, after the start of stimulation, the average amplitude can increase from C1 mV to B1 mV, where B1 is a pre-set threshold (pass condition), and the test interval is 0 to A1 mV, of which 0 <C1<B1<A1である。

[0118] Regarding rhythm, after the start of stimulation, amplitude continuity improves, changing from intermittent performance to sustained continuity (passing condition).

[0119] Regarding ordered entropy, after the start of the stimulus, the ordered entropy value of each observation region increases B2, where B2 is a predetermined threshold (pass condition), and the test interval is 0 to A2, of which 0 <B2<A2である。

[0120] Regarding sequence entropy, after the start of stimulation, the sequence entropy value of each monitored area increases B3, where B3 is a pre-set threshold (pass condition), and the test interval is 0 to A3, of which 0 <B3<A3である。

[0121] Regarding information interoperability, after the start of stimulation, the number of activated channels increases by C4 or C4% (passing condition), and the activity level of the activated channels changes from 0 to B4 (passing condition). The test interval is 0 to A4, and of these, 0 <B4<A4である。

[0122] Regarding the recurrence index of brain interval change, after the start of stimulation, the brain interval change index value can be reduced from B5 to C5, C5 is a pre-set threshold (pass condition), and the test interval is 0 to A5, of which 0 <C5<B5<A5である。

[0123] Regarding active motion monitoring, after the start of stimulation, the motion monitoring amplitude value changes from a steady state of 0 to a fluctuating state of non-0 (A6, passing condition).

[0124] In steps S32B and S62B, which compare the improvement effect and the expected effect, the improvement effect and corresponding expected effect of the average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information are compared preferentially, and combinations of stimulation points and stimulation parameters are selected in which these four types of biometric indicators meet the passing criteria.

[0125] When actually applying this, the user can be presented with comparative results, comparing the improvement effect and expected effect corresponding to each stimulus combination, and only the optimal set or the previous few sets can be presented for the user (doctor) to consider before making a selection.

[0126] As shown in Figure 8, in one embodiment, step S3 includes the following operations.

[0127] In S31C, the improvement effect is calculated for each biometric indicator corresponding to a combination of multiple stimulation points, compared to the biometric indicator before the start of stimulation.

[0128] In S32C, the improvement effect is compared with the expected effect, and a combination of stimulation points is selected in which the improvement effect is higher than the expected effect. This is similar to step S32B in the previous embodiment, but in this embodiment, a relatively small expected effect (for example, setting an expected effect that corresponds to only a portion of the biometrics) or a relatively low expected effect (a relatively low threshold) is set, and first, a combination of points (which may be multiple or one) that achieves the expected effect is selected from all possible point combinations.

[0129] In S33C, the improvement effects corresponding to the selected combinations of stimulation points are compared, and the combination of stimulation points that exhibits the optimal improvement effect is determined as the optimal stimulation point combination.

[0130] Step S6 includes the following actions:

[0131] In S61C, the improvement effect is calculated for each biometric corresponding to a combination of multiple stimulation parameters, compared to the biometric before the start of stimulation.

[0132] In S62C, the improvement effect is compared with the expected effect, and combinations of stimulation parameters in which the improvement effect is higher than the expected effect are selected.

[0133] In S63C, the improvement effects corresponding to multiple selected stimulation parameter combinations are compared, and the selected stimulation parameter combination that has the optimal improvement effect is determined as the optimal stimulation parameter combination.

[0134] In steps S32C and S62C, which compare the improvement effect and the expected effect, the improvement effect and corresponding expected effect of the average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information are compared preferentially, and combinations of stimulation points and stimulation parameters are selected in which these four types of bio-indicators meet the passing criteria. In steps S33C and S63C, the improvement effect of the average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information are compared preferentially, and the improvement effect of the other indicators is further judged only when the improvement effects of these four types of indicators are exactly the same.

[0135] When actually applying this to a situation, the user can be presented with comparison results. After comparing the improvement effect and expected effect corresponding to each stimulus combination, and comparing the combinations with each other, the optimal single combination or several previous combinations can be output for the user (doctor) to use as a reference before making a selection.

[0136] Those skilled in the art will understand that embodiments of this application may be provided as methods, systems, or computer program products. Accordingly, this application may take the form of complete hardware embodiments, complete software embodiments, or embodiments combining software and hardware aspects. Furthermore, this application may take the form of a computer program product implemented on one or more computer-readable storage media (including, but not limited to, magnetic disk storage devices, CD-ROMs, optical storage devices, etc.) containing computer-readable program code.

[0137] This application will be described with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of this application. It should be understood that each flow and / or block in the flowcharts and / or block diagrams, and combinations of flows and / or blocks in the flowcharts and / or block diagrams, can be implemented by computer program instructions. These computer program instructions are provided to a processor of a general-purpose computer, a dedicated computer, an embedded processor, or other programmable data processing device, so that the instructions executed by the computer or other programmable data processing device processor can generate means for performing a function specified in one or more flows of a flowchart and / or one or more blocks of a block diagram.

[0138] These computer program instructions may also be stored in computer-readable memory that can instruct a computer or other programmable data processing device to operate in a particular manner, and as a result, the instructions stored in computer-readable memory generate a product that includes instruction means for performing a function specified in one or more flows of a flowchart and / or one or more blocks of a block diagram.

[0139] These computer program instructions may also be loaded onto a computer or other programmable data processing device such that a series of operational steps are executed on the computer or other programmable data processing device to generate a computer implementation process, and the instructions executed on the computer or other programmable device provide steps to implement a function specified in one or more flows of a flowchart and / or one or more blocks of a block diagram.

[0140] It is clear that the embodiments described above are merely illustrative for clarity and do not limit the embodiments. Those skilled in the art can make other different forms of modifications or changes based on the above description. It is not necessary, nor is it possible, to cover all embodiments. Such obvious variations or changes are within the scope of this application.

Claims

1. A method for determining an electrical stimulation scheme to promote arousal in the rehabilitation of impaired consciousness, In the process in which an implantable spinal cord stimulator employs pre-set stimulation parameters and sequentially passes through a combination of multiple stimulation points, distinguishing at least one of the following: number of points, site of action, and polarity, each outputting a stimulation signal, the brainwave and electromyogram signals of the human body are collected. To calculate biometric indicators for the electroencephalogram (EEG) signals and electromyogram (EMG) signals corresponding to each combination of stimulation points, Based on the aforementioned biometric indicators, the optimal combination of stimulation points is determined from the combination of the plurality of stimulation points. In the process by which an implantable spinal cord stimulator passes through the optimal combination of stimulation points and sequentially adopts multiple combinations of stimulation parameters to output stimulation signals, electroencephalogram (EEG) and electromyogram (EMG) signals from the human body are collected, and the stimulation parameters include at least one parameter from stimulation amplitude, stimulation frequency, and pulse width, and different combinations of the stimulation parameters are distinguished by having at least one parameter with a different value. To calculate biometric indicators for the electroencephalogram (EEG) signals and electromyogram (EMG) signals corresponding to each combination of stimulation parameters, A method characterized by comprising determining the optimal combination of stimulation parameters from the combination of the plurality of stimulation parameters based on the aforementioned biometric indicators.

2. The method according to claim 1, wherein the biometric indicators include a brain activity indicator and a physical activity indicator, wherein the brain activity indicator includes at least one indicator from average amplitude, rhythm, ordinal entropy, sequence entropy, information interoperability information, and brain interstellar change recurrence information calculated based on the electroencephalogram signal, and the physical activity indicator includes an action monitoring amplitude value calculated based on the electromyogram signal.

3. In the method described in claim 2, determining the optimal combination of stimulation points from the combination of the plurality of stimulation points based on the biometrics is: For each of the combinations of stimulation points, the improvement effect is calculated by comparing the biometric indicator with the biometric indicator before the start of stimulation. This includes comparing the improvement effects corresponding to the combination of the plurality of stimulation points and determining the combination of stimulation points having the optimal improvement effect as the optimal combination of stimulation points. Determining the optimal combination of stimulation parameters from the multiple combinations of stimulation parameters based on the aforementioned biometric indicators means: For each of the combinations of the multiple stimulation parameters, the improvement effect is calculated by comparing the biometric indicator with the biometric indicator before the start of stimulation. A method characterized by comprising comparing the improvement effects corresponding to the combination of the plurality of stimulation parameters and determining the combination of stimulation parameters having the optimal improvement effect as the optimal combination of stimulation parameters.

4. The method according to claim 3, characterized in that, in the operation of comparing the improvement effects, the improvement effects of average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information are given priority in comparison.

5. In the method according to claim 2, determining the optimal combination of stimulation points from the combination of the plurality of stimulation points based on the biometrics is: For each of the combinations of stimulation points, the improvement effect is calculated by comparing the biometric indicator with the biometric indicator before the start of stimulation. This includes comparing the improvement effect with the expected effect, and determining the optimal combination of stimulation points in which the improvement effect is higher than the expected effect. Determining the optimal combination of stimulation parameters from the multiple combinations of stimulation parameters based on the aforementioned biometric indicators means: For each of the combinations of the multiple stimulation parameters, the improvement effect is calculated by comparing the biometric indicator with the biometric indicator before the start of stimulation. A method characterized by including comparing the improvement effect with the expected effect, and determining the optimal combination of stimulation parameters for which the improvement effect is higher than the expected effect.

6. In the method of claim 2, determining the optimal combination of stimulation points from the combination of the plurality of stimulation points based on the biometrics is: For each of the combinations of stimulation points, the improvement effect is calculated by comparing the biometric indicator with the biometric indicator before the start of stimulation. The improvement effect is compared with the corresponding expected effect, and a combination of stimulation points is selected in which the improvement effect is higher than the expected effect. This includes comparing the improvement effects corresponding to the selected combinations of stimulation points, and determining the combination of stimulation points that has the optimal improvement effect among the selected combinations of stimulation points as the optimal combination of stimulation points. Determining the optimal combination of stimulation parameters from the multiple combinations of stimulation parameters based on the aforementioned biometric indicators means: For each of the combinations of the multiple stimulation parameters, the improvement effect is calculated by comparing the biometric indicator with the biometric indicator before the start of stimulation. The improvement effect is compared with the expected effect, and a combination of stimulation parameters is selected in which the improvement effect is higher than the expected effect. A method characterized by comprising comparing the improvement effects corresponding to selected combinations of stimulation parameters, and determining the combination of stimulation parameters that has the optimal improvement effect among the selected combinations of stimulation parameters as the optimal combination of stimulation parameters.

7. The method according to claim 5 or 6, characterized in that, in the operation of comparing the improvement effects, the improvement effects of average amplitude, array entropy, motion monitoring amplitude value, and information interoperability information are given priority in comparison.

8. A method according to any one of claims 3 to 6, characterized in that the effect of improving the average amplitude includes an increase in the average amplitude, the effect of improving the rhythm includes an improvement in the continuity of the amplitude and a change from intermittent performance to sustained continuity, the effect of improving the ordered entropy includes an increase in the ordered entropy value of each monitoring region, the effect of improving the sequence entropy includes an increase in the sequence entropy value of each monitoring region, the effect of improving the information interoperability information includes an increase in the number of activated channels and an increase in the activity level of the activated channels, the effect of improving the brain interval change recurrence information includes a decrease in the brain interval change index value, and the effect of improving the motion monitoring amplitude value includes an increase in the motion monitoring amplitude value.

9. The method according to claim 1, characterized in that the electroencephalogram (EEG) signal is an EEG signal from a plurality of brain regions collected by an EEG collection cap having a plurality of collection points, and the electromyogram (EMG) signal is an EMG signal collected by at least one surface electrode placed on the surface of the skin of a limb of a human body.

10. A device for determining an electrical stimulation scheme to promote arousal for rehabilitation of impaired consciousness, comprising a processor and a memory connected to the processor, wherein the memory stores instructions that can be executed by the processor, and the instructions are executed by the processor so that the processor executes the method for determining an electrical stimulation scheme to promote arousal for rehabilitation of impaired consciousness described in any one of claims 1 to 9.

11. This is an awakening promotion system aimed at rehabilitation for impaired consciousness. A program control module that sets multiple combinations of stimulation points, distinguishing at least one of the following: number of points, site of action, and polarity; and multiple combinations of stimulation parameters, including at least one parameter among stimulation amplitude, stimulation frequency, and pulse width, where different combinations of stimulation parameters differ by at least one parameter value. An implantable spinal cord stimulation module that sequentially outputs stimulation signals according to the combination of the plurality of stimulation points and the combination of the plurality of stimulation parameters, A collection module for collecting electroencephalogram (EEG) and electromyogram (EMG) signals when the aforementioned stimulus signal acts on a patient with impaired consciousness, A system characterized by comprising: a processing module that processes the electroencephalogram signal and the electromyogram signal to obtain biometric indicators, and determines the optimal combination of stimulation points and the optimal combination of stimulation parameters from the combination of the plurality of stimulation points and the combination of the plurality of stimulation parameters based on the biometric indicators.

12. In the system according to claim 11, the program control module comprises a first signal input unit, a stimulation point parameter setting unit, a stimulation parameter setting unit, and a parameter wireless output unit. The first signal input unit receives several of the stimulus points and several of the stimulus parameters, The stimulation point parameter setting unit sets several combinations of stimulation points according to several of the stimulation points, The stimulus parameter setting unit sets a combination of multiple stimulus parameters according to several of the stimulus parameters, The system is characterized in that the parameter wireless output unit outputs the combination of the plurality of stimulation points and the combination of the plurality of stimulation parameters to the implantable spinal cord stimulation module.

13. In the system according to claim 11, the implantable spinal cord stimulation module comprises an implantable spinal cord stimulator, a spinal cord stimulation electrode, and a spinal cord electrode lead, The implantable spinal cord stimulator is characterized by receiving the combination of the plurality of stimulation points and the combination of the plurality of stimulation parameters, controlling the spinal cord stimulation electrode via the spinal cord electrode lead, and sequentially outputting stimulation signals corresponding to the combination of the plurality of stimulation points and the combination of the plurality of stimulation parameters.

14. In the system according to claim 11, the acquisition module comprises an electroencephalogram (EEG) acquisition unit, an electromyogram (EMG) acquisition unit, and a first signal output unit. The electroencephalogram (EEG) acquisition unit collects EEG signals via an EEG acquisition cap before the stimulus signal acts and when it acts on a patient with impaired consciousness. The electromyography acquisition unit acquires electromyographic signals via body surface electrodes before the stimulation signal acts and when it acts on a patient with impaired consciousness. The system is characterized in that the first signal output unit outputs the electroencephalogram signal and the electromyogram signal to a processing module using an electrode wire method or a wireless transmission method.

15. In the system according to claim 11, the processing module includes a second signal input unit, an algorithm determination unit, a storage display unit, and a second signal output unit. The second signal input unit receives the electroencephalogram signal and the electromyogram signal, The algorithm determination unit converts the electroencephalogram signal and the electromyogram signal to obtain biometric indicators, and based on the biometric indicators, compares the combination of multiple stimulation points and the combination of multiple stimulation parameters to determine the optimal combination of stimulation points and the optimal combination of stimulation parameters. The memory and display unit stores and displays the electroencephalogram signal, the electromyogram signal, the biometric indicators converted by the algorithm, the optimal combination of stimulation points, and the optimal combination of stimulation parameters. The system is characterized in that the second signal output unit outputs the optimal combination of stimulation points and the optimal combination of stimulation parameters to the program control module.

16. The system according to claim 11, wherein the biometric indicators include a brain activity indicator and a physical activity indicator, wherein the brain activity indicator includes at least one indicator from average amplitude, rhythm, sequential entropy, sequence entropy, information interoperability information, and brain interval change recurrence information calculated based on the electroencephalogram signal, and the physical activity indicator includes an action monitoring amplitude value calculated based on the electromyogram signal.

17. The system according to claim 11, wherein the processing module acquires electroencephalogram (EEG) signals and electromyogram (EMG) signals in the process in which an implantable spinal cord stimulator employs pre-set stimulation parameters and sequentially passes through a plurality of stimulation point combinations to output stimulation signals, calculates biometrics for the EEG signals and EMG signals corresponding to each stimulation point combination, and determines the optimal combination of stimulation points from the plurality of stimulation point combinations based on the biometrics.

18. The system according to claim 17, wherein the processing module calculates the improvement effect of each of the biometric indicators corresponding to the combination of the plurality of stimulation points compared with the biometric indicator before the start of stimulation, compares the improvement effects corresponding to the combination of the plurality of stimulation points, determines the combination of stimulation points having the optimal improvement effect as the optimal combination of stimulation points, or compares the expected effect corresponding to the improvement effect, selects the combination of stimulation points in which the improvement effect is higher than the expected effect, further compares the improvement effects corresponding to the selected combination of stimulation points, and determines the combination of stimulation points having the optimal improvement effect among the selected combination of stimulation points as the optimal combination of stimulation points.

19. The system according to claim 17, wherein the processing module acquires the electroencephalogram (EEG) signal and the electromyogram (EMG) signal during the process in which the implantable spinal cord stimulator passes through the optimal combination of stimulation points and sequentially adopts a plurality of combinations of stimulation parameters to output a stimulation signal, calculates a biometric for the EEG signal and the EMG signal corresponding to each combination of stimulation parameters, and determines the optimal combination of stimulation parameters from the plurality of combinations of stimulation parameters based on the biometric.

20. The system according to claim 19, wherein the processing module calculates the improvement effect of each of the biometric indicators corresponding to the combination of the plurality of stimulation parameters compared with the biometric indicator before the start of stimulation, compares the improvement effects corresponding to the combination of the plurality of stimulation parameters, determines the combination of stimulation parameters having the optimal improvement effect as the optimal combination of stimulation parameters, or compares the improvement effect with the expected effect, selects the combination of stimulation parameters in which the improvement effect is higher than the expected effect, further compares the improvement effects corresponding to the selected combination of stimulation parameters, and determines the combination of stimulation parameters having the optimal improvement effect among the selected combination of stimulation parameters as the optimal combination of stimulation parameters.

Images