Closed-loop electrical stimulation system and control method

Abstract

The application provides a closed-loop electric stimulation system and a control method, the closed-loop electric stimulation system comprising a device master control system, a trigger and control system, an electric stimulation system and an electric signal acquisition system, the device master control system being used for receiving a square wave trigger signal from an external device and processing the square wave trigger signal according to an electric stimulation working instruction, and transmitting the electric stimulation working instruction and the processed square wave trigger signal to the trigger and control system; the trigger and control system being used for receiving the square wave trigger signal and the electric stimulation working instruction, and generating a square wave signal in response to the square wave trigger signal by using a square wave generator contained in the trigger and control system; the electric stimulation system containing a plurality of signal channels, and being used for generating a plurality of electric stimulation signal outputs; and the electric signal acquisition system containing a plurality of signal channels, and being used for acquiring electric currents on a subject body subjected to the plurality of electric stimulation signal outputs, and obtaining a plurality of electric signal acquisition outputs, the plurality of electric signal acquisition outputs being used for adjusting parameters of the plurality of electric stimulation signal outputs.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of closed-loop electrical stimulation, and in particular to a closed-loop electrical stimulation system and a control method. BACKGROUND

[0002] Transcranial Electrical Stimulation (tES) is a non-invasive neural stimulation technique with less negative impact on people's body and psychology, and has become a hot spot for brain function research in recent years; according to the stimulation waveform output by transcranial electrical stimulation, it is divided into: transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation, etc.

[0003] The existing transcranial electrical stimulation technology generally adopts an open source stimulation mode, and it is difficult to know the current state of the patient, and if a closed-loop feedback is to be formed, it needs to be used in combination with other electroencephalogram devices, thereby increasing the technical and cost burden. Among them, the closed-loop feedback system refers to an automatic control system established based on the feedback principle, which compares the deviation between the behavior (output) and the expected behavior, and eliminates these deviations to achieve the expected performance of the system. Generally speaking, the closed loop contains a signal forward path and a signal feedback path, and the feedback can be positive feedback or negative feedback.

[0004] In recent years, new transcranial electrical stimulation application modes have appeared, making it difficult for the original transcranial electrical stimulation technology to adapt to the new changes, for example, the time-coherent electrical stimulation technology needs to monitor the coherent waveform, and in order to achieve better focusing effect, a multi-channel electrical stimulation technology is needed, which also poses new challenges for real-time detection of the current. SUMMARY

[0005] In view of this, the embodiments of the present application provide a closed-loop electrical stimulation system to eliminate or improve one or more defects in the prior art.

[0006] One aspect of the present application provides a closed-loop electrical stimulation system, which comprises a device master system, a trigger and control system, an electrical stimulation system and an electrical signal acquisition system, wherein: the device master system is configured to receive a square wave trigger signal and an electrical stimulation operation instruction from an external device, process the square wave trigger signal by using a trigger signal processing circuit included in the device master system, and transmit the electrical stimulation operation instruction and the processed square wave trigger signal to the trigger and control system; the trigger and control system is configured to receive the square wave trigger signal and the electrical stimulation operation instruction, and generate a square wave signal in response to the square wave trigger signal by using a square wave generator included in the trigger and control system, and transmit the generated square wave signal to the electrical stimulation system; the electrical stimulation system includes a plurality of signal channels, which are configured to generate a plurality of electrical stimulation signal outputs by using the generated square wave signal as an input, so that the device master system controls the electrical stimulation system to perform electrical stimulation on a subject by using the plurality of electrical stimulation signal outputs according to the electrical stimulation operation instruction; and the electrical signal acquisition system includes a plurality of signal channels, which are configured to acquire electrical current on the subject subjected to the plurality of electrical stimulation signal outputs, and obtain a plurality of electrical signal acquisition outputs, wherein the plurality of electrical signal acquisition outputs are used to adjust parameters of the plurality of electrical stimulation signal outputs to achieve closed-loop electrical stimulation.

[0007] In some embodiments of the present application, the device master system further includes a single-chip microcomputer, a first communication module, a second communication module, an operation display interface, a storage device and a data processing module; wherein the single-chip microcomputer is configured to control the working operation of the first communication module, the second communication module, the operation display interface, the storage device and the data processing module, and is further configured to receive the processed square wave trigger signal; the first communication module is connected to the external device, and is configured to receive signals or instructions from the external device; the single-chip microcomputer is configured to forward the square wave trigger signal to the second communication module, so that the second communication module transmits the square wave trigger signal to the trigger and control system; the operation display interface is connected to the single-chip microcomputer, and is configured to receive an externally input control instruction and present monitoring data of the closed-loop electrical stimulation; the storage device includes variable storage and non-variable storage, and is configured to store parameters related to the closed-loop electrical stimulation; and the data processing module is connected to the single-chip microcomputer, and is configured to perform calculation processing under the control of the single-chip microcomputer.

[0008] In some embodiments of the present application, the external device includes a user operation device and an external trigger device, wherein the user operation device is configured to generate a user operation instruction, and the external trigger device is configured to generate a square wave trigger signal.

[0009] In some embodiments of the present application, the trigger and control system comprises a third communication module, a single-chip microcomputer and a square wave generator; wherein the third communication module is in communication connection with the second communication module; the single-chip microcomputer is connected to the square wave generator, and is used to receive a square wave trigger signal from the device host system and control the square wave generator to generate a square wave signal; the single-chip microcomputer is also used to receive a multi-channel electric signal collection output from the electric signal collection system.

[0010] In some embodiments of the present application, each signal channel of the electric stimulation system comprises a signal generator, a low-pass filter, an analog-to-digital converter, a voltage amplifier, a voltage-to-current converter, a second low-pass filter, a sampling resistor and a waveform monitoring circuit; wherein the signal generator is used to generate an electric stimulation signal based on an input square wave signal, and is also controlled by the waveform monitoring circuit to ensure the stability of the final output electric stimulation signal; the low-pass filter is used to filter high-frequency noise in the electric stimulation signal; the analog-to-digital converter is used to convert the electric stimulation signal in analog-digital form into an electric stimulation signal in analog signal form; the voltage amplifier is used to adjust the size of the electric stimulation signal in analog signal form; the voltage-to-current converter is used to convert the electric stimulation signal in voltage form into an electric stimulation signal in current form by using a mirror current source; the second low-pass filter is used to filter the electric stimulation signal processed by the voltage-to-current converter; the sampling resistor comprises a plurality of different resistances, and is used to detect the current waveform of the electric stimulation signal and prevent short circuit; the waveform monitoring circuit is used to perform peak value monitoring, impedance monitoring and maximum output monitoring on the generated electric stimulation signal, and the electric stimulation signal meeting the preset requirements is output to the electrode.

[0011] In some embodiments of the present application, each signal channel of the electric signal collection system comprises a pre-stage low-pass filter, a differential pre-stage amplifier, a high-pass filter, a baseline drift removal circuit, a 50Hz notch filter, a low-pass filter, a post-stage amplifier, a level shift circuit and an analog-to-digital converter connected in sequence, the pre-stage low-pass filter is connected to the electrode, the electric signal collected from the electrode is returned to the single-chip microcomputer through the electric signal collection system, and thus an electric signal collection output is obtained.

[0012] In some embodiments of the present application, the electric signal collection system and the electric stimulation system share one end electrode, i.e. a multiplexing electrode, and the multiplexing electrode is controlled by a selection switch.

[0013] Correspondingly, another aspect of the present application provides a closed-loop electrical stimulation control method, which adopts an electrical stimulation control mode, and comprises the following steps: adjusting multiple types of signal waveforms, signal frequencies, signal phases and signal intensities in each signal channel of the electrical stimulation system; monitoring current output and voltage output of the output electrical stimulation signal in real time, and then monitoring impedance changes; measuring current intensity, peak value and impedance of the output electrical stimulation signal in real time, and forcibly interrupting the output of the electrical stimulation signal when any of the current intensity, peak value and impedance exceeds a predetermined threshold.

[0014] Another aspect of the present application provides a closed-loop electrical stimulation control method, which adopts an electroencephalogram acquisition control mode including impedance measurement and / or common reference acquisition, and comprises the following steps: adopting an impedance measurement mode to perform closed-loop electrical stimulation control, monitoring impedance changes in real time before obtaining multi-channel electrical signal acquisition output, and adjusting parameters of the multi-channel electrical stimulation signal output according to the monitored impedance changes; and / or adopting a common reference acquisition mode to perform closed-loop electrical stimulation control, with an electrode serving as one end of a signal channel of an electrical signal acquisition system and a signal channel of an electrical stimulation system, and the other end of the signal channel of the electrical signal acquisition system being connected to a reference electrode.

[0015] Another aspect of the present application provides a closed-loop electrical stimulation control method, which adopts a trigger control mode including external trigger control and / or internal trigger control, and comprises the following steps: adopting an external trigger control mode to perform closed-loop electrical stimulation control, with an external trigger device included in an external device generating a signal input to a device main control system, causing the device main control system to interrupt, executing an interruption program, sending an instruction to a trigger and control system, and controlling the electrical stimulation or electrical signal acquisition system to work after the trigger and control system receives the instruction; and / or adopting an internal trigger control mode to perform closed-loop electrical stimulation control, wherein the internal trigger control mode includes electrical stimulation triggering and acquisition signal triggering, the electrical stimulation triggering refers to using an output signal of a square wave signal generator to control the opening and closing of the electrical stimulation system, and the acquisition signal triggering refers to using a square wave signal generator to control the opening or stopping of receiving an electrical signal acquisition output returned by an electrical signal acquisition system.

[0016] Another aspect of the present application provides a closed-loop electrical stimulation control method, which adopts a threshold tracking feedback control mode, and comprises the following steps:

[0017] The digital signal generation chip in the signal generator generates two types of waveforms, one is a relatively wide square wave called a polarization pulse, and the other is a relatively narrow test pulse, which are synthesized together through a same-phase superposition circuit;

[0018] At the beginning, no polarization pulse is generated, only test pulse is generated, the intensity is gradually increased from zero, the electromyography of the corresponding muscle is collected by the electric signal acquisition system, when the obvious electromyography is observed, the output is stopped, and the intensity is the resting state threshold value; the output waveform of the square wave generator is set, and the repetition frequency is set according to the stimulation frequency; the square wave output by the square wave generator is input to the signal generator, the signal generator receives the square wave signal to output a pulse signal, the polarization pulse and the test pulse are output at the same time, and are synthesized through the in-phase adder, and the test pulse is gradually enhanced from zero; the square wave output by the square wave generator is input to the electric signal acquisition system, and the electric signal acquisition system starts to collect the signal; the square wave signal input to the single-chip microcomputer is output by the square wave generator, the single-chip microcomputer records the collection time of the square wave signal, and transmits to the equipment main control system; the equipment main control system divides the received electromyography into segments according to the collection time recorded by the single-chip microcomputer, calculates multiple values in the integral electromyography, peak value, average value or median frequency of each segment, and generates an integral electromyography change curve, taking the intensity of the test pulse as the horizontal coordinate and the calculated characteristic value as the vertical coordinate; with the increase of the test pulse, the change curve becomes flat, the inflection point intensity is recorded as the maximum integral electromyography, and the stimulation and collection are stopped, and the maximum integral electromyography of the preset percentage is set as the threshold value, and steps 3-7 are executed again, and when the calculated integral electromyography exceeds the threshold value with the increase of the test pulse intensity, the test pulse intensity is reduced.

[0019] In another aspect, the application provides a closed-loop electrical stimulation control method, which adopts a multi-frequency time interference stimulation feedback control mode, outputs multiple sine waves with different preset frequencies, collects waveforms of each channel in the same time period through waveform monitoring, takes an arbitrary channel as a reference, calculates correlation functions of the remaining channels with the reference channel, calculates phases, adjusts phases of each channel, calculates event-related potential spectrum, peak intensity, peak time, average value and other parameters, compares measured values with preset normal values, and adjusts parameters of the multi-channel electrical stimulation signal output.

[0020] The closed-loop electrical stimulation system and control method can collect the electrical stimulation signal size applied to the subject's body by using the electric signal acquisition system, adjust the parameters of the multi-channel electrical stimulation signal output by implementing the collected electrical stimulation signal size to realize closed-loop electrical stimulation, and realize the closed-loop feedback of transcranial electrical stimulation without the participation of other electroencephalogram devices. Through the closed-loop electrical stimulation, the current state of the patient can be known, and the current formed by the transcranial electrical stimulation is detected in real time, so that the new transcranial electrical stimulation mode is better adapted.

[0021] Additional advantages, objects, and features of the application will be set forth in part by the description that follows, and will become apparent to those skilled in the art upon examination of the following detailed description and drawings in which

[0022] Those skilled in the art will appreciate that the objects and advantages of the application can be practiced without resorting to the details of the following description, which are presented as examples and for the purpose of illustration. The above-mentioned and other advantages of the application will become readily apparent to those skilled in the art from the following detailed description, wherein embodiments of the application are shown and described by way of illustration. BRIEF DESCRIPTION OF DRAWINGS

[0023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the application and together with the description, serve to explain the principles of the application.

[0024] Figure 1 Structure diagram of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0025] Figure 2 Structure diagram of a device master control system of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0026] Figure 3 Structure diagram of a trigger and control system of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0027] Figure 4 Structure diagram of an electrical stimulation system of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0028] Figure 5 Structure diagram of an electrical signal acquisition system of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0029] Figure 6 Structure diagram of an electrode connection structure of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0030] Figure 7 Structure diagram of an electromyographic feedback mode of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0031] Figure 8 Structure diagram of phase adjustment of a neural feedback mode of a closed-loop electrical stimulation system and control method according to an embodiment of the present application.

[0032] Figure 9 Structure diagram of a neural feedback mode of a closed-loop electrical stimulation system and control method according to an embodiment of the present application. DETAILED DESCRIPTION

[0033] In order to make the objects, technical solutions and advantages of the present application clearer, the present application will be further described in detail below with reference to the embodiments and drawings. Herein, the illustrative embodiments of the present application and their descriptions are used to explain the present application but not as a limitation of the present application.

[0034] Herein, it should also be noted that, in order to avoid the present application being obscured by unnecessary details, only the structures and / or processing steps closely related to the solutions according to the present application are shown in the drawings, and other details not closely related to the present application are omitted.

[0035] It should be emphasized that the term "comprise / comprising" as used herein is used to indicate the presence of a feature, element, step or component but does not exclude the presence or addition of one or more other features, elements, steps or components.

[0036] Herein, it should also be noted that, if not specifically stated, the term "connection" as used herein can not only mean direct connection but also indirect connection with an intermediate.

[0037] Hereinafter, the embodiments of the present application will be described with reference to the drawings. In the drawings, the same reference numerals represent the same or similar parts or the same or similar steps.

[0038] The technical objects of the present application include: (1) proposing a closed-loop feedback implementation scheme of transcranial electrical stimulation without combining other electroencephalographic devices, and being able to know the current state of the patient through closed-loop electrical stimulation; (2) detecting the current formed by transcranial electrical stimulation in real time, so as to better adapt to new transcranial electrical stimulation modes.

[0039] In order to achieve the technical objects of the present application, the present application proposes a closed-loop electrical stimulation system, Figure 1 The structure diagram of the closed-loop electrical stimulation system and the control method in an embodiment of the present application. The closed-loop electrical stimulation system comprises a device main control system, a trigger and control system, an electrical stimulation system and an electrical signal acquisition system, and the functions of each part of the system are as follows:

[0040] (1) The main control system is used for receiving a square wave trigger signal and an electrical stimulation working instruction from an external device, processing the square wave trigger signal by using a trigger signal processing circuit contained in the device main control system, and transmitting the electrical stimulation working instruction and the processed square wave trigger signal to the trigger and control system.

[0041] In the specific implementation process, the device main control system can contain two communication modules, an operation display interface, a trigger signal processing circuit, a memory and a data processing module, the control module can realize information interaction with an external device, control of the subsystem and acquisition of electrical signal and electrical stimulation waveform data.

[0042] (2) a trigger and control system for receiving a square wave trigger signal and an electrical stimulation operation instruction, and generating a square wave signal in response to the square wave trigger signal by using a square wave generator contained in the trigger and control system, and transmitting the generated square wave signal to an electrical stimulation system.

[0043] In the specific implementation process, the trigger and control system can include a single-chip microcomputer, a square wave generator, a communication module, etc., and the trigger and control system accepts instructions transmitted from a device host system, and then controls the electrical stimulation and electrical signal acquisition subsystems to work, and uploads data to the device host system.

[0044] (3) the electrical stimulation system contains multiple signal channels, taking the generated square wave signal as input, for generating multiple electrical stimulation signal outputs, so that the device host system controls the electrical stimulation system to perform electrical stimulation on the subject by using the multiple electrical stimulation signal outputs according to the electrical stimulation operation instruction.

[0045] In the specific implementation process, the electrical stimulation system can contain multiple signal channels, each channel including a signal generator, a low-pass filter, an analog-to-digital converter, a voltage amplifier, a voltage-to-current converter, and a sampling resistor, etc., which can realize multiple electrical stimulation signal outputs.

[0046] (4) the electrical signal acquisition system contains multiple signal channels for acquiring the current on the subject subjected to the multiple electrical stimulation signal outputs, obtaining multiple electrical signal acquisition outputs, and adjusting the parameters of the multiple electrical stimulation signal outputs to realize closed-loop electrical stimulation. In the specific implementation process, the electrical signal acquisition system can contain multiple signal channels, each channel including a low-pass filter, a differential preamplifier, a high-pass filter, a 50Hz notch filter circuit, a baseline drift removal circuit, a post-amplification circuit, a level shift circuit, and an analog-to-digital conversion, etc., which can realize multiple electrical signal acquisition outputs. The electrical signal acquisition system can realize closed-loop electrical stimulation through cooperation with the electrical stimulation system, etc. The closed-loop electrical stimulation is a kind of neural regulation technology, which adjusts the intensity and frequency of electrical stimulation by real-time sensing of neural signals.

[0047] Based on the closed-loop electrical stimulation system proposed in the present application, the electrical signal acquisition system can be used to acquire the electrical stimulation signal size applied to the subject, and the parameters of the multiple electrical stimulation signal outputs can be adjusted by implementing the acquired electrical stimulation signal size to realize closed-loop electrical stimulation. The closed-loop electrical stimulation system proposed in the present application can realize closed-loop feedback of transcranial electrical stimulation without the participation of other electroencephalogram devices. Through closed-loop electrical stimulation, the current state of the patient can be known, and the current formed by transcranial electrical stimulation can be detected in real time, so as to better adapt to the new transcranial electrical stimulation mode.

[0048] In an embodiment of the present application, Figure 2 It is a schematic diagram of the structure of the device master system of the closed-loop electrical stimulation system and the control method in an embodiment of the present application. The device master system further comprises a single-chip microcomputer, a first communication module, a second communication module, an operation display interface, a storage device and a data processing module. The functions of each module included in the device master system are as follows:

[0049] (1) The single-chip microcomputer is used to control the working operation of the first communication module, the second communication module, the operation display interface, the storage device and the data processing module, and is also used to receive the square wave trigger signal processed by the trigger signal processing circuit;

[0050] (2) The first communication module is connected with external devices, and is used to receive signals or instructions from the external devices;

[0051] In the specific implementation process, the first communication module includes a serial transceiver module, an optical module, a Bluetooth module and a WiFi module. One end of the first communication module can be connected with external devices to communicate through serial ports, optical fibers or short-wave high-frequency radios, etc. The external devices include user-operable devices such as personal computers, and other devices include training equipment with the above communication functions, etc. The other end of the first communication module is connected with the single-chip microcomputer. The single-chip microcomputer controls the operation of the first communication module, receives data of the first communication module and sends data through the first communication module.

[0052] (3) The single-chip microcomputer is used to forward the square wave trigger signal to the second communication module, and the second communication module transmits the square wave trigger signal to the trigger and control system.

[0053] In the specific implementation process, the second communication module includes a serial transceiver module and an optical module. One end of the second communication module is connected with the single-chip microcomputer. The single-chip microcomputer controls the operation of the second communication module, receives data of the second communication module and sends data through the second communication module. The other end of the second communication module is connected with the trigger and control system through serial ports and optical fibers to transmit the information of the trigger and control system received.

[0054] (4) The operation display interface is connected to the single-chip microcomputer, and is used to receive external input control instructions and present monitoring data of the closed-loop electrical stimulation.

[0055] In the specific implementation process, the operation display interface can include a liquid crystal touch display screen, which is connected with the single-chip microcomputer and is used to control the device and display monitoring data, etc.

[0056] (5) The storage device includes variable storage and immutable storage, and is used to store parameters related to the closed-loop electrical stimulation.

[0057] In the specific implementation process, the variable storage and the non-variable storage device, including the built-in read-only optical disc and the solid state disk, the non-variable storage device contains the read-only optical disc storage device information, the device key and other unchangeable information, the solid state disk can be used for storing changeable data, the variable and non-variable storage devices are connected with the single-chip microcomputer and controlled by the single-chip microcomputer.

[0058] (6) The data processing module is connected to the single-chip microcomputer and controlled by the single-chip microcomputer to perform calculation processing. The data processing module can contain FPGA and DSP processing chips, and only the processing chip interface is reserved, and chips can be added as needed. The data processing module is connected with the single-chip microcomputer and controlled by the single-chip microcomputer.

[0059] In addition, the system further comprises a power module, the power module supplies power to the single-chip microcomputer mainboard circuit, and the mainboard circuit supplies power to the remaining modules.

[0060] In the specific implementation process, the trigger signal processing circuit comprises a BNC interface and a signal processing circuit. The BNC interface can be connected with an external trigger device. The external trigger device comprises a device with square wave output, such as an electroencephalogram acquisition device, a signal generator and the like. The signal processing circuit comprises an edge triggering, pulse triggering and level triggering mode, and the output end is connected with the interrupt interface of the single-chip microcomputer. The square wave is a kind of non-sinusoidal waveform, which usually appears in electronic signal processing. Its characteristic is that the signal value jumps between positive and negative values in a fixed time interval, so it is also called "jumping wave". Edge triggering, pulse triggering and level triggering all belong to a kind of trigger working mode.

[0061] In some embodiments of the application, the external device comprises a user operation device and an external trigger device. The user operation device is used to generate a user operation instruction, and the external trigger device is used to generate a square wave trigger signal.

[0062] In some embodiments of the application, Figure 3 It is a structure schematic view of the trigger and control system of the closed-loop electrical stimulation system and the control method in an embodiment of the application. The trigger and control system further comprises a third communication module, a single-chip microcomputer and a square wave generator. Functions of each module are as follows:

[0063] (1) The third communication module is connected with the second communication module to establish communication connection.

[0064] In the specific implementation process, the third communication module comprises a serial transceiver module and an optical module, which are connected with the second communication module and used for communication with the second communication module, and are connected with the single-chip microcomputer and controlled by the single-chip microcomputer.

[0065] (2) the single-chip microcomputer is connected to the square wave generator, and is configured to receive a square wave trigger signal from a device main control system and control the square wave generator to generate a square wave signal; wherein an input end of the square wave generator is connected to the single-chip microcomputer, the single-chip microcomputer controls the signal generator to send the square wave signal, and an output end of the square wave generator is connected to the electric stimulation system to control electric stimulation output, and the other end of the output port is connected to the single-chip microcomputer to calibrate time.

[0066] Specifically, the single-chip microcomputer can be configured to control the communication module, the square wave generator, the electric stimulation system and the electric signal acquisition system.

[0067] (3) the single-chip microcomputer is further configured to receive multi-channel electric signal acquisition output from the electric signal acquisition system.

[0068] In some embodiments of the present application, Figure 4 FIG. 1 is a structural schematic diagram of an electric stimulation system of a closed-loop electric stimulation system and control method according to an embodiment of the present application. Each signal channel of the electric stimulation system comprises a signal generator, a low-pass filter, an analog-to-digital converter, a voltage amplifier, a voltage-to-current converter, a second low-pass filter, a sampling resistor and a waveform monitoring circuit.

[0069] The functions of each module are as follows:

[0070] (1) the signal generator is configured to generate an electric stimulation signal based on an input square wave signal, and the signal generator is further controlled by the waveform monitoring circuit to ensure stability of the final output electric stimulation signal.

[0071] In the specific implementation process, the signal generator comprises a dual-channel digital signal generation chip and a same-phase superposition circuit, an input end of the signal generator is connected to a trigger and control system and is controlled by the single-chip microcomputer, and the input end of the signal generator is connected to a detection circuit and is controlled by the detection circuit. An output end of the digital signal generation chip is connected to an input end of the same-phase superposition circuit, and an output end of the same-phase superposition circuit is connected to a first low-pass filter.

[0072] (2) the low-pass filter is configured to filter high-frequency noise in the electric stimulation signal.

[0073] (3) the analog-to-digital converter is configured to convert the electric stimulation signal in analog-digital form into an electric stimulation signal in analog signal form.

[0074] (4) the voltage amplifier is configured to adjust the size of the electric stimulation signal in analog signal form. The voltage amplifier is configured to amplify the analog signal and can be used to control the size of the output current.

[0075] (5) the voltage current converter is used to convert the voltage form of the electrical stimulation signal into the current form of the electrical stimulation signal in the way of mirror current source, and convert the voltage signal into the current signal.

[0076] (6) the second low pass filter is used to filter the electrical stimulation signal processed by the voltage current converter;

[0077] (7) the sampling resistor contains a plurality of different resistance values, which are used to detect the current waveform of the electrical stimulation signal and prevent short circuit. For example, the different resistance values can be set as 50 ohms, 200 ohms, 1000 ohms and 1M ohms. The sampling resistor is used to detect the current waveform and prevent short circuit, and safety control.

[0078] (8) the waveform monitoring circuit is used to monitor the peak value, impedance and maximum output of the generated electrical stimulation signal, and the electrical stimulation signal meeting the preset requirements is output to the electrode. In the specific implementation process, the waveform monitoring includes two differential amplifiers, a signal conditioning circuit, an analog-to-digital converter and a simple operation circuit. One of the differential amplifiers monitors the voltage across the sampling resistor, inputs the differential signal into the signal conditioning circuit, inputs the filtered signal into the analog-to-digital converter to convert it into a digital signal, and inputs the digital signal into the operation circuit and returns it to the single-chip microcomputer. The other analog-to-digital converter measures the voltage difference between the input and output ends, inputs the signal into the operation circuit and the single-chip microcomputer after the conditioning circuit and the analog-to-digital converter. The operation circuit can perform the following calculations: calculating the current according to the voltage difference across the sampling resistor, calculating the impedance according to the calculated current and the voltage difference between the input and output ends, and comparing the calculation results with the preset values. If the preset values are exceeded, the operation current returns an interrupt signal to the signal generator, and sets the sampling resistor to 1M ohms. The preset values are set as the waveform peak value, the maximum impedance and the maximum current.

[0079] In addition, the system can also contain a square wave signal processing circuit, which includes a rising edge detection circuit and a pulse width detection circuit.

[0080] In some embodiments of the present application, Figure 5It is a structural schematic view of the electric signal acquisition system of the closed-loop electric stimulation system and the control method in an embodiment of the present application. Each signal channel of the brain electric signal acquisition system comprises sequentially connected pre-low-pass filter, differential pre-amplifier, high-pass filter, baseline drift removal circuit, 50Hz notch filter, low-pass filter, post-amplifier, level shift circuit and analog-digital converter. The pre-low-pass filter is connected to the electrode. The electric signal acquired from the electrode is returned to the single-chip microcomputer through the brain electric signal acquisition system, so as to obtain the electric signal acquisition output. In an embodiment of the present application, the electrode and the reference electrode must pass through the pre-low-pass filter before inputting the pre-amplifier. The filtered signal is inputted into the differential amplifier. The differential signal is inputted into the baseline drift removal circuit after high-pass filtering. Then, the signal is amplified again after 50Hz filtering and low-pass filtering. The signal is inputted into the analog-digital converter after adjusting the level. Finally, the processed signal is returned to the single-chip microcomputer. Moreover, the pre-low-pass filter can be controlled by the square wave signal to open or close the signal reception.

[0081] In some embodiments of the present application, the electric signal acquisition system and the electric stimulation system share an end electrode, i.e. a multiplexed electrode. That is, the electric stimulation path and the brain electric acquisition share an end electrode. The multiplexed electrode is controlled by the selection switch. Figure 6 It is a schematic view of the electrode connection structure of the closed-loop electric stimulation system and the control method in an embodiment of the present application. The selection switch connects the multiplexed electrode at one end. At the other end, the electric stimulation path is connected to the return electrode, and the brain electric acquisition path is connected to the reference electrode.

[0082] Based on the closed-loop electric stimulation system provided in the above embodiments of the present application, the following closed-loop electric stimulation control method can be realized. The control method comprises the electric stimulation control mode, the brain electric acquisition control mode, the trigger control mode and the feedback control mode.

[0083] In some embodiments of the present application, a closed-loop electric stimulation control method using the electric stimulation control mode is provided. The method comprises the following steps:

[0084] (1) adjusting multiple kinds of signal waveforms, signal frequencies, signal phases and signal intensities in each signal channel of the electric stimulation system;

[0085] (2) monitoring the current output and the voltage output of the output electric stimulation signal in real time, and further monitoring the impedance change;

[0086] (3) measuring the current intensity, the peak value and the impedance of the output electric stimulation signal in real time. When any one of the current intensity, the peak value and the impedance exceeds the predetermined threshold value, the output of the electric stimulation signal is forcibly interrupted.

[0087] In an embodiment of the present application, the method steps of closed-loop electrical stimulation using electrical stimulation control mode include: (1) adjusting the channel signal waveform, signal frequency, signal phase, signal intensity, selecting the superposition mode output and setting the slow rise and slow fall function, and electrical stimulation monitoring and safety control. (2) The signal waveform is an arbitrary signal generator output waveform, that is, the default form can be selected, that is, square wave (unidirectional or bidirectional), sine wave, triangular wave, sawtooth wave, or output through a self-defined function. (3) The signal frequency refers to the repetition frequency of the signal (sinusoidal wave refers to the signal frequency). (4) The signal phase refers to the relative phase between the channels. (5) The signal intensity refers to the electrode output current intensity, including the root mean square value and the amplitude. (6) The superposition mode refers to the use of two signal generators to output signals at the same time, and the signals are combined together through a superposition circuit. (7) The slow rise and slow fall function refers to adjusting the signal intensity, and the signal changes linearly according to the set time period. (8) The electrical stimulation detection refers to monitoring the current output and voltage output in real time during the stimulation process, and then monitoring the impedance change. (9) The safety control refers to measuring the output current intensity, peak value and impedance in real time during the stimulation process, and forcibly interrupting the output when the three exceed the predetermined threshold, and the sampling resistance is adjusted to the maximum resistance value.

[0088] In some embodiments of the present application, a closed-loop electrical stimulation control method using electroencephalogram acquisition control mode is proposed, and the electroencephalogram acquisition control mode includes impedance measurement and / or common reference acquisition. The method includes the following steps: using impedance measurement to control closed-loop electrical stimulation, monitoring impedance changes in real time before obtaining multi-channel electrical signal acquisition output, and adjusting the parameters of the multi-channel electrical stimulation signal output according to the monitored impedance changes; and / or using common reference acquisition to control closed-loop electrical stimulation, the signal channel of the electrical signal acquisition system and the signal channel of the electrical stimulation system share an electrode as one end, and the other end of the signal channel of the electrical signal acquisition system is connected to a reference electrode.

[0089] In a specific embodiment of the present application, the method steps of closed-loop electrical stimulation using electroencephalogram acquisition control mode include: (1) The impedance measurement refers to monitoring impedance changes in real time before electroencephalogram signal acquisition, and the device uses an electrical stimulation module to output, the waveform selects a low-frequency low-intensity unidirectional square wave, and the impedance is measured in real time through the impedance monitoring function of the electrical stimulation system. (2) The common reference acquisition refers to that all electroencephalogram channels share an electrode (common electrode with the electrical stimulation channel) as one end, and the other end is connected to a reference electrode.

[0090] In some embodiments of the present application, a closed-loop electrical stimulation control method using trigger control mode is proposed, and the trigger control mode includes external trigger control and / or internal trigger control. The method includes the following steps:

[0091] The external trigger control mode is used for closed-loop electric stimulation control, an external trigger device included in an external device generates a signal input to a device main control system, causing the device main control system to interrupt, execute an interrupt program, send an instruction to a trigger and control system, and the trigger and control system controls the electric stimulation or electric signal acquisition system to work after receiving the instruction; and / or, the internal trigger control mode is used for closed-loop electric stimulation control, the internal trigger control mode includes electric stimulation trigger and acquisition signal trigger, the electric stimulation trigger refers to using an output signal of a square wave signal generator to control the opening and closing of the electric stimulation system, and the acquisition signal trigger refers to using the square wave signal generator to control the opening or stopping of receiving the electric signal acquisition output returned by the electric signal acquisition system.

[0092] In another embodiment of the application, the trigger control mode includes external trigger control and internal trigger control. When the external trigger device needs to be synchronized with the external device, the external trigger device signal is input to the device main control system, causing the main control system to interrupt, executing an interrupt program, sending an instruction to the trigger and control system, and the trigger and control system controlling the electric stimulation or electric signal acquisition system to work after receiving the instruction. The internal trigger control is divided into two types, one is electric stimulation trigger, and the other is acquisition signal trigger. The electric stimulation trigger refers to that the output signal of the square wave signal generator can control the opening and closing of the electric stimulation system; the acquisition signal trigger refers to that the square wave signal generator can control the acquisition card to open or stop receiving the signal returned by the electric signal acquisition system or the monitoring signal of the electric stimulation system.

[0093] In some embodiments of the application, a closed-loop electric stimulation control method using threshold tracking feedback control mode is proposed, Figure 7Figure 1 is a schematic diagram of a myoelectric feedback mode of a closed-loop electrical stimulation system and control method according to an embodiment of the present application. The method comprises the following steps: (1) a digital signal generation chip in a signal generator generates two waveforms, one is a relatively wide square wave called polarization pulse, and the other is a relatively narrow test pulse, which are synthesized together through a same-phase superposition circuit; (2) initially, no polarization pulse is generated, only the test pulse is generated, the intensity is gradually increased from zero, and an electrical signal acquisition system acquires the myoelectric signal of the corresponding muscle. When a clear myoelectric signal is observed, the output is stopped, and the intensity is the resting state threshold value; (3) the output waveform of the square wave generator is set, and the repetition frequency is set according to the stimulation frequency; (4) the square wave generator sends a square wave to the signal generator, the signal generator receives the square wave signal and outputs a pulse signal, the polarization pulse and the test pulse are output at the same time, and are synthesized through a same-phase superposition device, and the test pulse is gradually increased from zero; (5) the square wave generator sends a square wave to the electrical signal acquisition system, and the electrical signal acquisition system starts to acquire the signal after receiving the signal. The electrical signal acquisition system only responds to the first square wave signal; (6) the square wave signal sent by the square wave generator is input to the single-chip microcomputer, the single-chip microcomputer records the acquisition time of the square wave signal, and transmits it to the device main control system; (7) the device main control system segments the received myoelectric signal according to the acquisition time recorded by the single-chip microcomputer, calculates multiple values in the integrated myoelectric, peak value, average value or median frequency of each segment, and generates an integrated myoelectric change curve, taking the intensity of the test pulse as the horizontal coordinate and the calculated characteristic value as the vertical coordinate; (8) as the test pulse intensity increases, the change curve becomes flat, and the inflection point intensity is recorded as the maximum integrated myoelectric. The stimulation and acquisition are stopped, and the maximum integrated myoelectric with a preset percentage is set as the threshold value. Steps 3-7 are executed again. When the calculated integrated myoelectric exceeds the threshold value, the test pulse intensity is reduced.

[0094] In another embodiment of the present application, the steps of the closed-loop electrical stimulation control method using threshold tracking feedback control mode specifically include:

[0095] (1) a digital signal generation chip in a signal generator generates two waveforms, one is a relatively wide square wave called polarization pulse, and the other is a relatively narrow test pulse, which are synthesized together through a same-phase superposition circuit. The polarization pulse intensity is generally 10% of the resting threshold value (which can be negative), and the pulse width can be set to 40 ms. The test pulse intensity can be adjusted, and the pulse width is set to 2 ms, and the phase is set to 20 ms after the polarization pulse occurs.

[0096] (2) initially, no polarization pulse is generated, only the test pulse is generated, the intensity is gradually increased from zero, and an electrical signal acquisition system acquires the myoelectric signal of the corresponding muscle (for example, the stimulation electrode is arranged on the ulnar nerve of the forearm, and the acquisition electrode is arranged on the thenar muscle). When a clear myoelectric signal is observed, the output is stopped, and the intensity is the resting state threshold value.

[0097] (3) Set the square wave generator output waveform, according to the stimulation frequency set the repetition frequency (set to 10Hz), the duty cycle is set to 10%.

[0098] (4) Square wave generator sends square wave input to signal generator, signal generator receives square wave signal output once pulse signal, polarization pulse and test pulse output at the same time, through the in-phase adder synthesis, test pulse from zero gradually enhanced.

[0099] (5) Square wave generator sends square wave input to the electrical signal acquisition system, and the electrical signal acquisition system only responds to the first square wave signal.

[0100] (6) Square wave signal input to the single-chip microcomputer, the single-chip microcomputer records the rising edge time (acquisition time) of the square wave signal, and transmits to the main control system.

[0101] (7) The main control system divides the received myoelectric signal according to the acquisition time recorded by the single-chip microcomputer, calculates the integral myoelectric, peak value, average value, median frequency or other self-defined characteristics of each segment, and generates an integral myoelectric change curve (the horizontal coordinate is the intensity of the test pulse, and the vertical coordinate is the calculated characteristic value).

[0102] (8) With the enhancement of the test pulse, the change curve becomes flat, and the inflection point intensity is recorded as the maximum integral myoelectric, and the stimulation and acquisition are stopped.

[0103] (9) Set the maximum integral myoelectric of 40% as the threshold, and execute steps (3)-(7) again, when the calculated integral myoelectric exceeds the threshold with the increase of the test pulse intensity, reduce the test pulse intensity, and the reduction amplitude is: (integral myoelectric-threshold) / threshold* pulse intensity = reduced intensity.

[0104] In some embodiments of the present application, a closed-loop electrical stimulation control method using a multi-frequency time interference stimulation feedback control method is proposed, Figure 8 It is a schematic diagram of phase adjustment of a neural feedback method of a closed-loop electrical stimulation system and control method in an embodiment of the present application. Figure 9 It is a schematic diagram of a neural feedback method of a closed-loop electrical stimulation system and control method in another embodiment of the present application. The method outputs multiple sine waves of different preset frequencies, acquires waveforms of all channels in the same time period through waveform monitoring, takes any channel as a reference, calculates correlation functions of the remaining channels with the reference channel, calculates phases, adjusts phases of all channels, calculates event-related potential spectrum, peak intensity, peak time, average value and other parameters, compares the measured values with the preset normal values, and adjusts parameters of the multiple electrical stimulation signal outputs.

[0105] In an embodiment of the present application, the closed-loop electric stimulation control method using multi-frequency time interference stimulation feedback control mode specifically comprises the following steps:

[0106] (1) The control system sends a command to the electric stimulation device to start multi-channel electric stimulation output (for example, three channels, output 1000Hz, 1010Hz, 1020Hz sine waves respectively).

[0107] (2) Collect the waveforms of each channel in the same time period through waveform monitoring, take any channel as a reference, calculate the correlation function of the remaining channels with the reference channel, calculate the phase (select a zero-crossing point of the reference channel, and another zero-crossing point of another channel), and adjust the phase of each channel.

[0108] (3) The square wave generator generates a square wave signal (10Hz, 50% duty cycle), and the waveform monitoring detects the rising edge to start collection and detects the falling edge to stop collection. The collected data is transmitted to the main control system, which calculates the superposition waveform of each channel and displays it.

[0109] (4) According to the displayed superposition waveform, adjust the square wave phase so that the main peak of the superposition waveform is displayed on the display screen included in the device main control system.

[0110] (5) Keep the square wave output, stop the collection trigger, and the single-chip microcomputer records the rising edge and falling edge occurrence time. The electric signal acquisition system starts measuring the signal.

[0111] (6) The main control system divides the collected electric signal according to the rising edge and falling edge time recorded by the single-chip microcomputer, continuously superimposes the divided signals, and obtains the event-related electric potential.

[0112] (7) Calculate the parameters of the event-related electric potential spectrum, peak intensity, peak time, and average value, compare the measured values with those of normal people, and adjust the corresponding electric stimulation parameters.

[0113] The closed-loop electric stimulation system and control method proposed in the present application can collect the electric stimulation signal size applied to the subject's body using the electric signal acquisition system, adjust the parameters of the multi-channel electric stimulation signal output by implementing the collected electric stimulation signal size to realize closed-loop electric stimulation. The closed-loop electric stimulation system proposed in the present application can realize closed-loop feedback of transcranial electric stimulation without the participation of other electroencephalogram devices. Through closed-loop electric stimulation, the current state of the patient can be known, and the current formed by transcranial electric stimulation can be detected in real time, thereby better adapting to new transcranial electric stimulation methods.

[0114] Those of ordinary skill in the art will appreciate that the various illustrative components, systems and methods described in connection with the embodiments disclosed herein can be implemented as hardware, software, or both. The particular implementation is dependent on the specific application and design constraints imposed on the overall system. Skilled persons can implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application. When implemented in hardware, for example, the hardware can comprise an electronic circuit, an Application Specific Integrated Circuit (ASIC), a suitable firmware, a plug-in, a functional card, etc. When implemented in software, the elements of the application are the program or code segments to perform a specific task. The program or code segments can be stored in a machine-readable medium, or transmitted by a carrier wave as data signals over a transmission medium or communication link.

[0115] It is to be understood that the application is not limited to the particular configurations and processes described herein and shown in the drawings. For simplicity, detailed descriptions of known methods and apparatuses are omitted so as not to obscure the disclosure. In the above-described embodiments, several specific steps are described and illustrated as examples. However, the method processes of the present application are not limited to the specific steps described and illustrated, and the order of the steps can be changed, or other steps can be added, or replaced, or eliminated, depending on the application.

[0116] In the present application, features described and / or illustrated in relation to one embodiment can be used in the same or a similar way in one or more other embodiments, and / or combined with or instead of features of other embodiments.

[0117] The above description is only preferred embodiments of the present application, and is not intended to limit the present application. The embodiments of the present application can be variously changed and modified by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the present application.

Claims

1. A closed loop electrical stimulation system, characterized by, The closed-loop electric stimulation system comprises a device master control system, a trigger and control system, an electric stimulation system and an electric signal acquisition system, and the system comprises: The device master control system is used for receiving a square wave trigger signal and an electric stimulation working instruction from an external device, processing the square wave trigger signal by using a trigger signal processing circuit contained in the device master control system, and transmitting the electric stimulation working instruction and the processed square wave trigger signal to the trigger and control system. The trigger and control system is used for receiving the square wave trigger signal and the electric stimulation working instruction, and generating a square wave signal in response to the square wave trigger signal by using a square wave generator contained in the trigger and control system, and the generated square wave signal is transmitted to the electric stimulation system. The electric stimulation system comprises a plurality of signal channels, and the generated square wave signal is used as an input to generate a plurality of electric stimulation signal outputs, so that the device master control system controls the electric stimulation system to perform electric stimulation on a subject by using the plurality of electric stimulation signal outputs according to the electric stimulation working instruction. The electric signal acquisition system comprises a plurality of signal channels, and is used for acquiring an electric current on the subject subjected to the plurality of electric stimulation signal outputs to obtain a plurality of electric signal acquisition outputs, and the plurality of electric signal acquisition outputs are used to adjust parameters of the plurality of electric stimulation signal outputs to realize closed-loop electric stimulation. Each signal channel of the electric stimulation system comprises an operation circuit and a waveform monitoring circuit, the operation circuit is used for calculating a current according to a voltage difference across a sampling resistor, and calculating an impedance according to the calculated current and a voltage difference across an input and output terminal, the waveform monitoring circuit is used for peak value monitoring, impedance monitoring and maximum output monitoring of the generated electric stimulation signal, and the electric stimulation signal meeting preset requirements is output to an electrode. Each signal channel of the electric stimulation system further comprises a low-pass filter, a second low-pass filter and a voltage amplifier, wherein the low-pass filter is used for filtering high-frequency noise in the electric stimulation signal, the second low-pass filter is used for filtering processing the electric stimulation signal processed by a voltage-current converter, and the voltage amplifier is used for adjusting the size of the electric stimulation signal in the form of an analog signal.

2. The closed loop electrical stimulation system of claim 1, wherein, The device master control system further comprises a single-chip microcomputer, a first communication module, a second communication module, an operation display interface, a storage device and a data processing module, wherein: The single-chip microcomputer is used for controlling the working operation of the first communication module, the second communication module, the operation display interface, the storage device and the data processing module, and is also used for receiving the square wave trigger signal processed by the trigger signal processing circuit; The first communication module is connected with the external device, and is used for receiving signals or instructions from the external device; The single-chip microcomputer is used for forwarding the square wave trigger signal to the second communication module, and the second communication module transmits the square wave trigger signal to the trigger and control system; The operation display interface is connected to the single-chip microcomputer, and is used for receiving an externally input control instruction and presenting monitoring data of the closed-loop electric stimulation; The storage device comprises variable storage and immutable storage, and is used for storing parameters related to the closed-loop electric stimulation; The data processing module is connected to the single-chip microcomputer and is controlled by the single-chip microcomputer to perform calculation processing.

3. The closed loop electrical stimulation system of claim 1, wherein, The external device includes a user operation device for generating a user operation instruction and an external trigger device for generating a square wave trigger signal.

4. The closed loop electrical stimulation system of claim 2, wherein, The trigger and control system includes a third communication module, a single-chip microcomputer and a square wave generator; wherein, The third communication module is in communication connection with the second communication module; The single-chip microcomputer is connected to the square wave generator, and is used for receiving a square wave trigger signal from a device host system and controlling the square wave generator to generate a square wave signal; The single-chip microcomputer is also used for receiving a multi-channel electric signal collection output from an electric signal collection system.

5. The closed loop electrical stimulation system of claim 1, wherein, Each signal channel of the electric stimulation system includes a signal generator, an analog-digital converter, a voltage-current converter and a sampling resistor; wherein, The signal generator is used for generating an electric stimulation signal based on an input square wave signal, and is also controlled by a waveform monitoring circuit to guarantee the stability of the final output electric stimulation signal; The analog-digital converter is used for converting the electric stimulation signal in an analog-digital form into an electric stimulation signal in an analog signal form; The voltage-current converter is used for converting the electric stimulation signal in a voltage form into an electric stimulation signal in a current form by using a mirror current source mode; The sampling resistor includes a plurality of different resistance values, and is used for detecting a current waveform of the electric stimulation signal and preventing short circuit.

6. The closed loop electrical stimulation system of claim 1, wherein, The electric signal collection system is an electroencephalogram signal collection system, and each signal channel of the electroencephalogram signal collection system includes sequentially connected pre-stage low-pass filters, differential pre-stage amplifiers, high-pass filters, baseline drift removal circuits, 50Hz notch filters, low-pass filters, post-stage amplifiers, level shift circuits and analog-digital converters, the pre-stage low-pass filters are connected to electrodes, and the electric signals collected from the electrodes are returned to the single-chip microcomputer through the electroencephalogram signal collection system, so that an electric signal collection output is obtained.

7. The closed loop electrical stimulation system of claim 6, wherein, The electric signal collection system and the electric stimulation system share a common electrode, i.e. a multiplexing electrode, which is controlled by a selection switch.

8. A closed loop electrical stimulation control method, characterized in that, The method adopts an electric stimulation control mode, is used for non-treatment purposes, is based on the closed-loop electric stimulation system according to any one of claims 1-7, and includes the following steps: adjusting multiple kinds of signal waveforms, signal frequencies, signal phases and signal intensities in each signal channel of the electric stimulation system; monitoring current output and voltage output of the output electric stimulation signal in real time, and further monitoring impedance changes; measuring current intensity, peak value and impedance of the output electric stimulation signal in real time, and forcibly interrupting the output of the electric stimulation signal when any one of the current intensity, peak value and impedance exceeds a predetermined threshold.

9. A closed loop electrical stimulation control method, characterized in that, The method is based on the closed-loop electric stimulation system according to any one of claims 1-7, is used for non-treatment purposes, adopts an electroencephalogram collection control mode including impedance measurement and / or common reference collection, and includes the following steps: performing closed-loop electric stimulation control by using an impedance measurement mode, monitoring impedance changes in real time before obtaining a multi-channel electric signal collection output, adjusting parameters of the multi-channel electric stimulation signal output according to the monitored impedance changes; and / or The closed-loop electric stimulation control is performed by using a common reference collection mode, a signal channel of an electric signal collection system and a signal channel of an electric stimulation system share an electrode as one end, and the other end of the signal channel of the electric signal collection system is connected to a reference electrode.

10. A closed loop electrical stimulation control method, characterized in that, The method is implemented based on the closed-loop electric stimulation system according to any one of claims 1-7, is used for non-treatment purposes, adopts a trigger control mode, the trigger control mode includes external trigger control and / or internal trigger control, and the method includes the following steps: The closed-loop electric stimulation control is performed by using an external trigger control mode, an external trigger device included in an external device generates a signal input to a device main control system, causes the device main control system to interrupt, executes an interruption program, sends an instruction to a trigger and control system, and the trigger and control system controls the electric stimulation or electric signal collection system to work after receiving the instruction; and / or The closed-loop electric stimulation control is performed by using an internal trigger control mode, the internal trigger control mode includes electric stimulation triggering and signal collection triggering, the electric stimulation triggering refers to using an output signal of a square wave signal generator to control the opening and closing of the electric stimulation system, and the signal collection triggering refers to using the square wave signal generator to control the opening or stopping of receiving an electric signal collection output returned by the electric signal collection system.

11. The closed loop electrical stimulation control method of claim 10, wherein, The method adopts a threshold tracking feedback control mode, and the method includes the following steps: the trigger control mode includes feedback control, and one implementation mode of the feedback control is the threshold tracking feedback control mode; The digital signal generation chip in the signal generator generates two waveforms, one is a relatively wide square wave, referred to as a polarization pulse, and the other is a relatively narrow test pulse, which are synthesized together through a same-phase superposition circuit; At the beginning, no polarization pulse is generated, only the test pulse is generated, the intensity starts from zero and gradually increases, the electric signal collection system collects the electromyographic signals of the corresponding muscles, when the obvious electromyographic signals are observed, the output is stopped, and the intensity is the resting state threshold value; The output waveform of the square wave generator is set, and the repetition frequency is set according to the stimulation frequency; The square wave generator sends a square wave to the signal generator, the signal generator receives the square wave signal and outputs a pulse signal, the polarization pulse and the test pulse are output at the same time, and are synthesized through a same-phase superposition circuit, and the test pulse gradually increases from zero; The square wave generator sends a square wave to the electric signal collection system, the electric signal collection system starts to collect signals after receiving the signal; The square wave signal input to the single-chip microcomputer is recorded by the single-chip microcomputer, and is transmitted to the device main control system; The device main control system segments the received electromyographic signals according to the collection time recorded by the single-chip microcomputer, calculates multiple values in the integral electromyography, peak value, average value or median frequency of each segment, and generates an integral electromyography change curve, taking the intensity of the test pulse as the horizontal coordinate and the calculated characteristic value as the vertical coordinate; With the increase of the test pulse, the change curve becomes flat, the inflection point intensity is recorded as the maximum integral electromyography, the stimulation and collection are stopped, the maximum integral electromyography is set as the threshold value, and steps 3-7 are executed again, when the calculated integral electromyography exceeds the threshold value with the increase of the test pulse intensity, the test pulse intensity is reduced.

12. The closed loop electrical stimulation control method of claim 10, wherein, The method adopts a multi-frequency time interference stimulation feedback control mode, the method outputs a plurality of sine waves of different preset frequencies, collects waveforms of each channel in the same time period through waveform monitoring, takes an arbitrary channel as a reference, calculates correlation functions of the remaining channels and the reference channel, calculates phases, adjusts phases of each channel, compares measured values with preset normal values by calculating event-related potential spectrum, peak intensity, peak time and average value, and adjusts parameters of multi-channel electric stimulation signal output; the trigger control mode includes feedback control, and another mode of feedback control is a multi-frequency time interference stimulation feedback control mode.

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