A multimodal physiological signal-guided transcranial magnetic stimulation medical system

Abstract

This application relates to the field of detection and treatment technology for neurological and mental illnesses. This application discloses a transcranial magnetic stimulation (TMS) medical system guided by multimodal physiological signals. It includes: a host computer software module, a navigation robot, a TMS device, a stimulation coil, a stimulation pulse conversion module, a multimodal physiological signal acquisition terminal, and a physiological probe connected to the multimodal physiological signal acquisition terminal. The host computer software module includes: an examination item unit, a data processing unit, a protocol management unit, a synchronization control unit, and an evaluation system. The technical solution of this application effectively solves the technical problems of poor synchronization between traditional TMS devices and the body's physiological signal detection, inaccurate target marking, fragmented functions, and a single evaluation dimension through hardware and software linkage control, synchronous acquisition of multimodal physiological signals and stimulation pulse signals, automatic target marking, and highly integrated software management. It also provides convenience for efficacy evaluation.

Description

Technical Field

[0001] This application relates to the field of detection and treatment technology for neurological and mental illnesses, and in particular to the technology of combining transcranial magnetic stimulation (TMS) devices with physiological signal detection. Specifically, it relates to a multimodal physiological signal-guided TMS medical system. Background Technology

[0002] Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulation technique that uses a transcranial magnetic stimulation device to non-invasively penetrate the skull and target neurons in the cerebral cortex, thereby precisely regulating brain metabolism and neural electrical activity.

[0003] Currently, transcranial magnetic stimulation (TMS) technology is mainly used in speech localization and cognitive function research to promote the recovery of brain and motor functions; it is also used to treat neurological and mental illnesses such as depression, schizophrenia, Parkinson's disease, epilepsy, and movement disorders. It is a painless, non-invasive, and green neuromodulation and treatment approach.

[0004] Mental illnesses are all characterized by autonomic nervous system dysfunction. The autonomic nervous system is an important component of the nervous system, composed of the sympathetic and parasympathetic nervous systems. These two systems antagonize and synergistically regulate visceral activity and physiological homeostasis. When the autonomic nervous system receives information from the body and the external environment, sympathetic activation can trigger somatic stress responses such as increased heart rate, accompanied by a decrease in overall heart rate variability. Parasympathetic activation mediates relaxation responses such as decreased heart rate, accompanied by an increase in overall heart rate variability. The dynamic changes in this regulatory process can be reflected directly or indirectly by monitoring physiological signals such as photoplethysmography (PPG), electrocardiogram (ECG), and respiration (RESP).

[0005] Therefore, transcranial magnetic stimulation (TMS) is often combined with individual physiological signal acquisition technologies such as PPG, electrocardiogram (ECG), and respiration to achieve personalized and precise regulation and treatment of mental illnesses. However, existing technologies have the following problems:

[0006] (1) Target marking relies on manual marking and is not accurate enough: The correspondence between stimulation target and physiological signal needs to be marked manually, which makes it impossible to accurately locate the start and end positions of stimulation pulse, resulting in bias in the causal relationship analysis between TMS stimulation and autonomic nerve function.

[0007] (2) Poor equipment synchronization and large synchronization error: The physiological signal acquisition equipment and the transcranial magnetic stimulation equipment are independent equipment. For the application scenario of transcranial magnetic stimulation guided by neurocardiology, if the two types of equipment are simply connected by lead wires and the start and stop of the equipment are controlled manually, the time synchronization error between the acquired physiological signal and the transcranial magnetic stimulation pulse signal will usually be >1s, which cannot meet the synchronization requirements of neurocardiology guidance.

[0008] (3) Dispersed functions and low operational efficiency: Transcranial magnetic stimulation device program management, physiological signal acquisition and data analysis are operated independently by multiple software programs, which is cumbersome and has poor data compatibility. Data loss or errors are likely to occur in clinical applications.

[0009] (4) Single assessment dimension: Relying solely on a single signal (such as electrocardiogram) to assess efficacy makes it difficult to fully reflect the neuromodulation physiological effects of transcranial magnetic stimulation, resulting in biased efficacy assessment or failure to reflect the neuromodulation effect of transcranial magnetic stimulation.

[0010] Chinese patent application CN202310389492 discloses an automated heart rate-navigated transcranial magnetic stimulation (TMS) system based on a virtual brain electrode positioning system. Its core idea is to apply stimulation at different pre-stimulation sites based on preset stimulation parameters, simultaneously acquire electrocardiogram (ECG) signals, and perform comparative analysis to determine the site with the largest heart rate change as the optimal treatment target. This system attempts to screen target points from the perspective of the regulatory effect of TMS on the heart, aiming to reduce positioning errors caused by individual differences and improve the specificity and accuracy of the stimulation target location. However, this system still has significant technical shortcomings, specifically: limited signal acquisition (only ECG signals are acquired), poor synchronization (lack of a dedicated synchronization calibration mechanism), and limited dimensions for efficacy evaluation (relying solely on the amplitude of heart rate changes to judge the quality of the stimulation target), making it difficult to adapt to individualized neuromodulation needs. Summary of the Invention

[0011] The main objective of this application is to provide a transcranial magnetic stimulation (TMS) medical system guided by multimodal physiological signals. Through hardware and software linkage control, synchronous acquisition of multimodal physiological signals and stimulation pulse signals, automatic target marking, and highly integrated software management, it effectively solves the technical problems of poor synchronization between traditional TMS devices and the detection of physiological signals, inaccurate target marking, scattered functions, and single evaluation dimensions. It provides convenience for the selection of stimulation targets and stimulation parameters related to autonomic nerve function and the evaluation of therapeutic effects.

[0012] To achieve the above objectives, according to one aspect of a specific embodiment of this application, a multimodal physiological signal-guided transcranial magnetic stimulation medical system is provided, comprising:

[0013] The system includes a host computer software module, a navigation robot, a transcranial magnetic stimulation (TMS) device, a stimulation coil, a stimulation pulse conversion module, a multimodal physiological signal acquisition terminal, and a physiological probe connected to the multimodal physiological signal acquisition terminal. The host computer software module interacts with the navigation robot, the TMS device, and the multimodal physiological signal acquisition terminal.

[0014] The host computer software module includes: an inspection item unit, a data processing unit, and a scheme management unit;

[0015] Its characteristic is that it also includes a synchronization control unit;

[0016] The synchronization control unit is used to realize delay compensation and synchronous start-up and shutdown of the transcranial magnetic stimulation device and the multimodal physiological signal acquisition terminal.

[0017] In some embodiments:

[0018] The stimulation pulse sampling rate of the transcranial magnetic stimulator is configured to be consistent with the sampling rate of the multimodal physiological signal acquisition terminal.

[0019] In some embodiments:

[0020] The sampling rate is configured and adjusted via host computer software.

[0021] In some embodiments:

[0022] The synchronization control unit is built into the host computer software module.

[0023] In some embodiments:

[0024] The data processing unit includes a time alignment unit and a causal correlation analysis unit;

[0025] The time alignment unit is used to detect the first high-level start point of the stimulation pulse signal of the transcranial magnetic stimulation device, and mark the physiological signal position corresponding to the start point as the start position of the current stimulation cycle.

[0026] The time alignment unit is used to count the number of high-level pulse signals. When the count value matches the preset value, the position of the physiological signal corresponding to the high level is marked as the end position of the current stimulation cycle.

[0027] The causal correlation analysis unit is used to quantify the collected physiological signals and stimulation pulse signals, and analyze the correlation characteristics between the stimulation of the body by a transcranial magnetic stimulation device and the dynamic changes in the body's autonomic nervous function.

[0028] In some embodiments:

[0029] The scheme management unit has built-in multimodal physiological signal acquisition scheme and transcranial magnetic stimulation scheme;

[0030] The physiological signal acquisition scheme includes selecting which physiological signals to acquire and setting the acquisition duration.

[0031] The transcranial magnetic stimulation protocol includes the selection of targets and parameters for various neurological diseases.

[0032] In some embodiments:

[0033] The multimodal physiological signal acquisition terminal includes: an electrocardiogram signal acquisition module, a pulse wave signal acquisition module, a respiratory signal acquisition module, a skin conductance signal acquisition module, and a stimulation pulse receiving module; the start / stop and parameter configuration of each module can be uniformly managed and dynamically adjusted through host computer software.

[0034] In some embodiments:

[0035] The host computer software module interacts with the navigation robot through first control commands and status feedback; the first control commands include: adjusting the position of the transcranial magnetic stimulation coil, locating the stimulation coil, and tracking the stimulation coil in real time.

[0036] The host computer software module interacts with the transcranial magnetic stimulation device through a second control command and status feedback; the second control command includes: adjustment of stimulation parameters and start / stop of stimulation.

[0037] The host computer software module interacts with the multimodal physiological signal acquisition terminal through a third control command and digital stimulation pulses and digital physiological signal feedback; the third control command includes starting and stopping the multimodal physiological signal acquisition terminal; the multimodal physiological signal acquisition terminal acquires human physiological signals through physiological probes; the physiological signals include: electrocardiogram signals, pulse wave signals, respiratory signals, and skin conductance signals.

[0038] In some embodiments:

[0039] The stimulation pulse conversion module converts the acquired stimulation coil pulse signal into a digital stimulation pulse signal; the digital stimulation pulse signal is transmitted to the multimodal physiological signal acquisition terminal via USB, and then fed back to the host computer software module.

[0040] The multimodal physiological signal acquisition terminal converts the acquired physiological signals into digital signals.

[0041] In some embodiments:

[0042] It also includes an evaluation system, which comprises a stimulation target evaluation module, a stimulation parameter evaluation module, and a stimulation efficacy evaluation module.

[0043] The assessment system utilizes the transcranial magnetic stimulation medical system guided by the multimodal physiological signals to perform stimulation target assessment, stimulation parameter assessment, and stimulation efficacy assessment. The medical system is used to regulate autonomic nervous function to alleviate or treat mental illnesses caused by autonomic nervous system regulatory dysfunction.

[0044] The stimulation target assessment module evaluates stimulation targets using the multimodal physiological signal-guided transcranial magnetic stimulation medical system described in this application. By analyzing the multimodal physiological signals and comparing the differences in the regulatory effects of different targets, the module assesses the regulatory effect of different transcranial magnetic stimulation targets on autonomic nerve function.

[0045] The stimulation parameter evaluation module evaluates stimulation parameters through the multimodal physiological signal-guided transcranial magnetic stimulation medical system described in this application. By analyzing the multimodal physiological signals, the regulatory effects of different parameters are clarified, and the regulatory effects of different transcranial magnetic stimulation parameters on autonomic nerve function are evaluated.

[0046] The stimulation efficacy assessment module uses the transcranial magnetic stimulation medical system guided by multimodal physiological signals as described in this application to assess the stimulation efficacy. It achieves full-cycle assessment before, during, and after stimulation through multimodal physiological signals, comprehensively reflecting the regulatory effect of the transcranial magnetic stimulation device on autonomic nerve function.

[0047] According to the technical solution of this application and the technical solution further improved therein in some exemplary embodiments, this application has the following beneficial effects:

[0048] (1) To address the issue of "target marking relying on manual intervention and lacking precision," which leads to deviations in the location of the stimulation pulse start and end points and distortions in causal correlation analysis, directly affecting the accuracy of target selection, the upper computer software module automatically detects the transcranial magnetic stimulation pulse signal, marks the stimulation target points and pulse start and end points, and combines millisecond-level time alignment and point-by-point time axis mapping between the stimulation pulse and multimodal physiological signals to achieve automated and precise correlation marking of target points, stimulation, and physiological signals without manual intervention, eliminating the bias of manual marking from the source. At the same time, the stimulation parameter evaluation and stimulation efficacy evaluation processes reuse this automated marking and time alignment technology to ensure that the correlation of target signals at different parameters and different efficacy stages is accurate.

[0049] (2) To address the problem of "poor equipment synchronization and large synchronization error," which fails to meet the synchronization requirements of neurocardiac guidance, a unified calibration test and synchronization error compensation mechanism was designed. The communication delay of the equipment is recorded by issuing instructions through the host computer software module. The delay is compensated by "issuing the start instruction in advance," ensuring that the synchronization start-stop error between the physiological signal acquisition terminal and the transcranial magnetic stimulation device is within milliseconds. Using a multimodal signal acquisition terminal with the same sampling rate and the transcranial magnetic stimulation device for pulse synchronous acquisition achieves data synchronization, which is of great significance for evaluating therapeutic efficacy.

[0050] (3) In response to the problem of "dispersed functions and low operational efficiency," existing transcranial magnetic stimulation (TMS) devices operate independently for program management, physiological signal acquisition, and data analysis, resulting in cumbersome processes, poor data compatibility, and easy data loss. The three major processes of stimulation target assessment, stimulation parameter assessment, and stimulation efficacy assessment in this application are all completed on the same host computer software module platform. From the selection of examination items, signal channel configuration, and stimulation program management, to signal acquisition, automatic data analysis, and assessment report generation, and then to the unified command issuance by the navigation robot and TMS device, all functional modules are highly integrated, eliminating the need to switch between multiple software programs and achieving a "one-click" assessment process. Simultaneously, data is transmitted, stored, and analyzed within the same platform, completely solving the problems of dispersed functions and poor data compatibility, and significantly improving operational efficiency.

[0051] (4) Regarding the issue of "single assessment dimension," existing transcranial magnetic stimulation (TMS) devices cannot fully reflect the physiological effects of neuromodulation, directly leading to the one-sidedness of target selection, parameter optimization, and efficacy evaluation. The three assessment processes in this application are all based on multimodal physiological signal acquisition. All assessment processes can be configured to acquire ECG, pulse wave, respiration, skin conductance, and single / multi-channel pulses from the TMS device. Stimulation target assessment analyzes the differences in the regulatory effects of different targets through multimodal signal analysis. Stimulation parameter assessment analyzes the regulatory effects of different parameters through multimodal signal analysis. Stimulation efficacy evaluation realizes full-cycle assessment from pre-stimulation to post-stimulation through multimodal signals. The entire process from target selection and parameter optimization to efficacy verification is free from dependence on a single signal, fully reflecting the regulatory effect of the TMS device on autonomic nerve function, making the assessment results more objective and comprehensive.

[0052] The present application will be further described below with reference to the accompanying drawings and specific embodiments. Additional aspects and advantages of the present application will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present application. Attached Figure Description

[0053] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The detailed embodiments, illustrative examples, and descriptions thereof are used to explain this application and do not constitute an undue limitation of this application. In the drawings:

[0054] Figure 1 This is a block diagram of a multimodal physiological signal-guided transcranial magnetic stimulation medical system according to a specific embodiment of this application;

[0055] Figure 2 A flowchart illustrating the stimulation target evaluation process according to a specific embodiment of this application;

[0056] Figure 3 This is a flowchart illustrating the stimulation parameter evaluation process according to a specific embodiment of this application;

[0057] Figure 4 This is a flowchart illustrating the evaluation of the stimulant efficacy according to a specific embodiment of this application. Detailed Implementation

[0058] It should be noted that, unless otherwise specified, the specific embodiments, exemplary embodiments, and features thereof in this application can be combined with each other. This application will now be described in detail with reference to the accompanying drawings and the following description.

[0059] To enable those skilled in the art to better understand the present application, the technical solutions in the specific embodiments and exemplary embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described exemplary embodiments are only some embodiments of the present application, and not all embodiments. Based on the specific embodiments and exemplary embodiments of the present application, all other embodiments and implementations obtained by those skilled in the art without creative effort should fall within the scope of protection of the present application.

[0060] Example

[0061] The multimodal physiological signal-guided transcranial magnetic stimulation medical system of this embodiment, such as... Figure 1 As shown, it includes: a host computer software module, a navigation robot, a transcranial magnetic stimulation device, a stimulation coil, a stimulation pulse conversion module, a multimodal physiological signal acquisition terminal, and a physiological probe connected to the multimodal physiological signal acquisition terminal; the host computer software module interacts with the navigation robot, the transcranial magnetic stimulation device, and the multimodal physiological signal acquisition terminal respectively.

[0062] The host computer software module in this embodiment includes: an inspection project unit, a data processing unit, a scheme management unit, and a synchronization control unit.

[0063] The synchronization control unit in this embodiment is used to realize delay compensation and synchronous start-up and shutdown of the transcranial magnetic stimulation device and the multimodal physiological signal acquisition terminal.

[0064] In this embodiment, the stimulation pulse sampling rate of the transcranial magnetic stimulation device is configured to be consistent with the sampling rate of the multimodal physiological signal acquisition terminal.

[0065] The sampling rate is configured and adjusted through the host computer software module to ensure that the sampling time of the stimulation pulse signal matches that of the physiological signal.

[0066] In this embodiment, the synchronization control unit is built into the host computer software module, such as... Figure 1 As shown.

[0067] The data processing unit in this embodiment includes a time alignment unit and a causal correlation analysis unit.

[0068] The time alignment unit is used to detect the first high-level start point of the stimulation pulse signal of the transcranial magnetic stimulation device and mark the physiological signal position corresponding to the start point as the start position of the current stimulation cycle.

[0069] The time alignment unit counts the number of high-level pulses in the stimulation pulse signal. When the count matches a preset value, the position of the physiological signal corresponding to that high level is marked as the end position of the current stimulation cycle. The preset value is calculated based on the parameters in transcranial magnetic stimulation, and is the stimulation time multiplied by the stimulation frequency, which is the total number of pulses in a single stimulation.

[0070] By configuring the stimulation pulse sampling rate and marking the start and end positions of the stimulation cycle, physiological signals and stimulation pulse signals from the transcranial magnetic stimulation device can be precisely mapped point by point on the time axis, achieving millisecond-level time alignment between the stimulation time of the transcranial magnetic stimulation device and the physiological signal acquisition.

[0071] The causal correlation analysis unit is used to quantify the collected physiological signals and stimulation pulse signals, and analyze the correlation characteristics between the stimulation of the body by transcranial magnetic stimulation device and the dynamic changes of the body's autonomic nervous function, so as to achieve comprehensive analysis and correlation determination of heart rate variability, blood oxygen fluctuation and respiratory variability indicators.

[0072] The scheme management unit of this embodiment has a built-in multimodal physiological signal acquisition scheme and a transcranial magnetic stimulation scheme.

[0073] The physiological signal acquisition scheme includes the selection of which physiological signals to acquire, which can be a single physiological signal (such as ECG [electrocardiogram], PPG [pulse wave], RESP [respiration]) or multiple physiological signals (such as ECG+PPG or ECG+RESP, etc.), as well as the acquisition duration setting. Transcranial magnetic stimulation (TMS) schemes include commonly used stimulation schemes for target and parameter selection, as well as treatment schemes for different diseases, such as depression and insomnia.

[0074] The protocol management unit also includes a closed-loop feedback unit for real-time monitoring of physiological signal indicators and preset abnormal thresholds. When an indicator triggers an abnormal threshold, the host computer software module immediately issues an abnormality alert and provides operation options, allowing users to independently select transcranial magnetic stimulation protocols. This enables personalized adaptation and optimization of stimulation protocols, improving the targeting and efficacy of neuromodulation.

[0075] The multimodal physiological signal acquisition terminal in this embodiment includes: an electrocardiogram (ECG) signal acquisition module, a pulse wave signal acquisition module, a respiratory signal acquisition module, a skin conductance signal acquisition module, and a stimulation pulse receiving module. The start / stop and parameter configuration of each module can be uniformly managed and dynamically adjusted through the host computer software module.

[0076] In this example, the ECG signal acquisition module extracts heart rate, RR interval (heartbeat interval), and heart rate variability for optimal treatment target selection, parameter optimization, and efficacy evaluation. The pulse wave signal acquisition module monitors blood oxygenation and pulse rate, providing early warning of hypoxia or respiratory depression, and serves as a reference for ECG signal artifact correction. The respiratory signal acquisition module acquires and analyzes respiratory rhythm or variability, providing early warning of respiratory abnormalities, and is used for studying the timing of transcranial magnetic stimulation (TMS) with respiratory phase locking. The skin conductance signal acquisition module acquires and analyzes skin conductance response data, quantifying the activation level and dynamic changes of the sympathetic nervous system during TMS stimulation. This data is used to analyze the mechanism of action of TMS on autonomic nervous system regulation and provides supplementary autonomic nervous function indicators for stimulation target screening, stimulation parameter optimization, and efficacy evaluation. The stimulation pulse receiving module, in conjunction with the stimulation pulse conversion module, completes the signal reception after the stimulation pulse of the transcranial magnetic stimulation device is converted. This ensures that the pulse signal is accurately matched with multimodal physiological signals such as electrocardiogram, pulse wave, respiration, and skin conductance on the time axis, thereby providing key data for the host computer software to automatically mark stimulation target points and locate the start and end positions of stimulation.

[0077] In this embodiment, the host computer software module is connected to the navigation robot, the multimodal physiological signal acquisition terminal, and the transcranial magnetic stimulation (TMS) device via a network. The navigation robot is connected to the stimulation coil via a robotic arm; the stimulation coil is connected to the stimulation pulse conversion module via a physical component (such as Velcro); the stimulation pulse conversion module is connected to the multimodal physiological signal acquisition terminal via USB; and the TMS device is connected to the stimulation coil via a wire.

[0078] In this example, the host computer software module interacts with the navigation robot through first control commands and status feedback. These first control commands include: adjusting the position of the transcranial magnetic stimulation (TMS) coil, locating the stimulation coil, and real-time tracking of the stimulation coil. This method drives the robotic arm to accurately locate, adjust the posture of, and track the stimulation coil in real time. It supports repeated positioning and dynamic adaptation of the target point, and allows for real-time adjustment of the coil position based on physiological signal feedback or control commands during stimulation, improving the accuracy of target point positioning and the degree of automation.

[0079] In this example, the host computer software module interacts with the transcranial magnetic stimulation device through the second control command and status feedback. Here, the second control command includes the adjustment of stimulation parameters and the start and stop commands for stimulation.

[0080] In this example, the host computer software module interacts with the multimodal physiological signal acquisition terminal through third control commands and digital stimulation pulses and digital physiological signal feedback. The third control commands here include start and stop commands for the multimodal physiological signal acquisition terminal.

[0081] In this example, the multimodal physiological signal acquisition terminal acquires human physiological signals through a physiological probe and converts them into digital signals. These signals include electrocardiogram signals, pulse wave signals, respiratory signals, and skin conductance signals.

[0082] In this embodiment, the stimulation pulse conversion module converts the acquired stimulation coil pulse signal into a digital stimulation pulse signal, which is transmitted to the multimodal physiological signal acquisition terminal via USB and then fed back to the host computer software module.

[0083] The multimodal physiological signal-guided transcranial magnetic stimulation medical system of this embodiment can be used for stimulation target assessment, stimulation parameter assessment, and stimulation efficacy assessment to regulate autonomic nervous function and achieve the purpose of alleviating or treating mental illnesses caused by autonomic nervous system regulatory dysfunction.

[0084] Stimulation target assessment analyzes the differences in regulatory effects of different targets through multimodal physiological signal analysis; stimulation parameter assessment analyzes the regulatory effects of different parameters through multimodal physiological signal analysis; stimulation efficacy assessment achieves full-cycle assessment before, during and after stimulation through multimodal physiological signals, comprehensively reflecting the regulatory effect of transcranial magnetic stimulation on autonomic nerve function.

[0085] The evaluation described in this example automatically detects the transcranial magnetic stimulation (TMS) pulse signal, marks the stimulation target location and pulse start and end positions through the host computer software module, and combines the millisecond-level time alignment of the stimulation pulse and multimodal physiological signals with point-by-point time axis mapping to achieve automated, precise association and marking of the target, stimulation, and physiological signals, as well as delay compensation.

[0086] The stimulation target assessment, stimulation parameter assessment, and stimulation efficacy assessment described in this example all adopt a unified calibration test and synchronization error compensation mechanism. The upper computer software module issues instructions to record the device communication delay, and the delay is compensated by "issuing the start instruction in advance" to ensure that the synchronization start and stop error of the multimodal physiological signal acquisition terminal and the transcranial magnetic stimulation device is within the millisecond level. A high sampling rate (usually ≥500Hz) is used to synchronously acquire multimodal physiological signals and stimulation pulses from the transcranial magnetic stimulation device.

[0087] In this example, the evaluation of stimulation targets, stimulation parameters, and stimulation efficacy are all completed within the same host computer software module. From selecting examination items, configuring signal channels, and managing stimulation protocols, to signal acquisition, automatic data analysis, and generating evaluation reports, and then to the unified command issuance to the navigation robot and transcranial magnetic stimulation device, a "one-click" evaluation process is achieved. At the same time, data is transmitted, stored, and analyzed within the same host computer software module.

[0088] The assessments described in this example are all based on multimodal physiological signal acquisition. All assessment procedures can be configured to combine physiological signals and transcranial magnetic stimulation pulses in multiple channels. Stimulation target assessment analyzes the differences in the regulatory effects of different targets through multimodal physiological signals. Stimulation parameter assessment analyzes the regulatory effects of different parameters through multimodal physiological signals. Stimulation efficacy assessment realizes full-cycle assessment from pre-stimulation to post-stimulation through multimodal physiological signals. The entire process, from target selection and parameter optimization to efficacy verification, is free from dependence on a single signal and comprehensively reflects the regulatory effect of transcranial magnetic stimulation on autonomic nerve function.

[0089] The following flowcharts describe the specific evaluation processes for stimulation target assessment, stimulation parameter assessment, and stimulation efficacy assessment. The evaluation process in this application employs a multimodal signal acquisition terminal with the same sampling rate and a transcranial magnetic stimulation (TMS) pulse synchronization method, along with calibration testing and synchronization error compensation methods to achieve data synchronization.

[0090] 1. Stimulation target assessment, the assessment process is as follows: Figure 2 As shown, the specific steps include:

[0091] Inspection items and signal channel settings: Users select the "Stimulation target assessment" item through the host computer software module to complete the signal acquisition channel configuration. The configurable signal acquisition channels include ECG, pulse wave, respiration, skin conductance and transcranial magnetic stimulation pulse. It supports single-channel independent acquisition or arbitrary combination acquisition of multiple channels. The channel combination mode can be selected and configured through the host computer software module. At the same time, the pre-acquisition time of physiological signals before stimulation is set to 60 seconds.

[0092] Program distribution and transcranial magnetic stimulation (TMS) program selection: The host computer software module distributes the configured signal acquisition program to the multimodal physiological signal acquisition terminal, and simultaneously redirects to the TMS program selection interface. Users can select stored stimulation programs as needed (e.g., target points Fp2, F3, Fp1, F4, C3, intensity 80% of resting motion threshold, stimulation frequency 5Hz, stimulation time 5 seconds, interval time 60 seconds, cycle 65 seconds, repetition count 3 times), or perform operations to add new stimulation programs or modify existing programs, achieving personalized adaptation of stimulation programs.

[0093] Stimulation target serialization configuration: First, the five selected targets (e.g., Fp2, F3, Fp1, F4, C3) are randomly sorted. Based on this basic order (e.g., the target stimulation order generated by serialization method 1 is Fp1, Fp2, F3, F4, C3, Fp1, Fp2, F3, F4, C3, Fp1, Fp2, F3, F4; or the target stimulation order generated by serialization method 2 is Fp1, Fp1, Fp1, Fp2, Fp2, Fp2, F3, F3, F3, F4, F4, F4, C3, C3, C3), two serialization stimulation methods are provided for selection. After completing the serialization configuration as needed, proceed to the subsequent process.

[0094] Calibration Testing and Synchronization Error Compensation: The host computer software module sends the selected stimulation protocol and target sequence configuration to the transcranial magnetic stimulation (TMS) device, and synchronously records the delay data (e.g., 1 second) between sending the command to receiving the stimulation pulses from the TMS device. To ensure synchronization, subsequent TMS start commands are sent with an advance delay (e.g., 1 second) to ensure synchronous start and stop of the multimodal physiological signal acquisition terminal and the TMS device, with an error in the millisecond range. Multiple measurements of the synchronization start and stop error data are shown in Table 1. In this example, the medical system records the device communication delay by sending commands through the host computer software module and compensates for the delay by "sending the start command in advance," ensuring that the synchronization start and stop error between the physiological signal acquisition terminal and the TMS device is in the millisecond range. Using a multimodal signal acquisition terminal with the same sampling rate and the TMS device for synchronous pulse acquisition to achieve data synchronization is of great significance for evaluating therapeutic efficacy.

[0095] Start-up assessment and signal synchronization acquisition marking: The host computer software module first sends a start command to the multimodal physiological signal acquisition terminal to start the pre-acquisition of physiological signals 60 seconds before stimulation; when the pre-acquisition reaches 60 seconds - delay data (e.g., 1s), a start command is sent to the transcranial magnetic stimulation device to achieve precise synchronization of physiological signals and transcranial magnetic stimulation. During stimulation, the RR gap is collected and calculated in real time, and the Z score of each target point is calculated in real time based on the RR gap (e.g., the Z scores of target points Fp2, F3, Fp1, F4, and C3 are -0.23, 0.9, 0.22, 0.1, and -0.8, respectively); at the same time, the stimulation target point label, stimulation start position, and stimulation end position are automatically marked on the physiological signal waveform and heart rate (RR gap) waveform displayed on the host computer. Among them, the Z score is calculated as shown in formula (1), and the last RR gap trough before stimulation is defined as the trough of the last RR gap before stimulation. The first three troughs during and after stimulation were marked as , , , Indicates the first The average of the first three troughs is repeated. For 3 repetitions The average value, Indicates three repetitions Standard deviation;

[0096]

[0097] Closed-loop feedback and manual control: During the stimulation and signal acquisition process of the transcranial magnetic stimulation device, the host computer monitors core physiological indicators such as heart rate, respiratory rate, and blood oxygen saturation in real time. When an indicator is detected to exceed the preset abnormal threshold (e.g., blood oxygen saturation <90%), an abnormal prompt is issued. The user can choose the operation direction according to the prompt: if the user chooses to adjust the position of the stimulation coil, the host computer software module sends the positioning and posture adjustment instructions to the navigation robot, which then performs precise adjustment of the coil position; if the user chooses to modify the stimulation parameters or stop the stimulation operation, the host computer software module directly sends the parameter adjustment or stop instructions to the transcranial magnetic stimulation device to complete the corresponding operation.

[0098] Evaluation of target stimulation effect: After all sequential target stimulation is completed, the system conducts a comprehensive quantitative analysis of the Z score and RR interval time series data corresponding to each target through the causal association analysis unit; combined with the preset criterion of using the maximum Z score as the criterion for determining the optimal neuromodulation effect, the analysis results show that the Z score of the F3 target is the maximum value in this test, and it can be determined that the neuromodulation effect of the F3 target is optimal.

[0099] Evaluation Report Generation: The system automatically generates a complete evaluation report of stimulation targets. The report includes a heart rate (RR interval) change trend graph, marking information of each stimulation target, records of stimulation start and end positions, pre-collected physiological index data before stimulation, and real-time monitoring index data during stimulation, providing complete data support for target selection and subsequent stimulation program optimization.

[0100] 2. Stimulus parameter assessment, the assessment process is as follows: Figure 3 As shown, the specific steps include:

[0101] Check items and signal channel settings: Users can select the "Stimulation Parameter Evaluation" item through the host computer software module to complete the signal acquisition channel configuration. The configurable signal acquisition channels include ECG, pulse wave, respiration, skin conductance and transcranial magnetic stimulation pulse. It supports single-channel independent acquisition or arbitrary combination acquisition of multiple channels. The channel combination mode can be selected and configured through the host computer software module. At the same time, the pre-acquisition time of physiological signals before stimulation is set to 60 seconds.

[0102] Program distribution and transcranial magnetic stimulation (TMS) program selection: The host computer software module distributes the configured signal acquisition program to the multimodal physiological signal acquisition terminal, and simultaneously redirects to the TMS program selection interface. Users can select a stored stimulation program as needed (e.g., target F4, intensity 80% of resting motion threshold, stimulation frequency 5Hz, stimulation time 5 seconds, interval time 60 seconds, cycle 65 seconds, repetition count 3 times), or perform operations to add a new stimulation program or modify an existing program, thus achieving personalized adaptation of the stimulation program.

[0103] Calibration testing and synchronization error compensation: The host computer software module sends the selected stimulation program to the transcranial magnetic stimulation device and synchronously records the delay data (e.g., 1 second) of the instruction being sent to receive the stimulation pulse from the transcranial magnetic stimulation device; to ensure synchronization, when the transcranial magnetic stimulation device start instruction is subsequently sent, the delay data (e.g., 1 second) is sent in advance to ensure the synchronous start and stop of the multimodal physiological signal acquisition terminal and the transcranial magnetic stimulation device, with an error in the millisecond range.

[0104] Initiation Assessment and Signal Synchronization Acquisition Marking: The host computer software module first sends a start command to the multimodal physiological signal acquisition terminal to initiate the pre-acquisition of physiological signals for 60 seconds before stimulation. When the pre-acquisition reaches 60 seconds of delayed data (e.g., 1 second), a start command is sent to the transcranial magnetic stimulation device to achieve precise synchronization between physiological signals and transcranial magnetic stimulation. During stimulation, the host computer calculates and monitors various physiological indicators in real time (e.g., the baseline heart rate values ​​for the three repeated stimulations are 82.87 bpm, 80.43 bpm, and 78.53 bpm, respectively; the maximum values ​​of all heart rate peaks in the three repeated stimulations are 81.08 bpm, 78.54 bpm, and 77.55 bpm, respectively; blood oxygen saturation is stable at 98%; and respiratory rate is stable at 12 breaths / min). Simultaneously, the stimulation target label, stimulation start position, and stimulation end position are automatically marked on the physiological signal waveform and heart rate (RR interval) waveform displayed on the host computer.

[0105] Closed-loop feedback and manual control: During the stimulation and signal acquisition process of the transcranial magnetic stimulation device, the host computer monitors core physiological indicators such as heart rate, respiratory rate, and blood oxygen saturation in real time. When an indicator exceeds the preset abnormal threshold (such as heart rate > 100 beats / min), an abnormal prompt is issued. The user can choose the operation direction according to the prompt: if the user chooses to adjust the position of the stimulation coil, the host computer software module sends the positioning and posture adjustment instructions to the navigation robot, which then performs precise adjustment of the coil position; if the user chooses to modify the stimulation parameters or stop the stimulation operation, the host computer software module directly sends the parameter adjustment or stop instructions to the transcranial magnetic stimulation device to complete the corresponding operation.

[0106] Stimulation effect evaluation: Before the formal conclusion of the evaluation, users can choose other stimulation programs for re-evaluation, which facilitates comparative analysis of the regulatory effects under different combinations of stimulation parameters and provides data support for the optimization of individualized treatment plans. After the conclusion of the evaluation, the system performs data processing through the causal association analysis unit. If the maximum heart rate decreases relative to the baseline value after three repeated stimulations (for example, the results show that the maximum heart rate decreases by 1.79 beats / min, 1.89 beats / min, and 0.98 beats / min relative to the baseline value after three repeated stimulations), it indicates that the target (F4) can produce a regulatory effect of reducing heart rate under this set of stimulation parameters.

[0107] Evaluation Report Generation: The system automatically generates a complete evaluation report of stimulation parameters. The report includes a heart rate change trend chart, stimulation target label annotation, stimulation start and end position records, pre-collected physiological index data before stimulation, and real-time monitoring index data during stimulation, providing complete data support for the analysis of stimulation effects of different parameters and subsequent program optimization.

[0108] 3. Evaluation of the therapeutic effect of stimulation, the evaluation process is as follows: Figure 4As shown, the specific steps include:

[0109] Inspection items and signal channel settings: Users select the "Stimulation Therapy Assessment" item through the host computer software module to complete the signal acquisition channel configuration. The configurable signal acquisition channels include ECG, pulse wave, respiration, skin conductance and transcranial magnetic stimulation pulses. It supports single-channel independent acquisition or arbitrary combination acquisition of multiple channels. The channel combination mode can be selected and configured through the host computer software module. At the same time, the pre-acquisition time of physiological signals before stimulation is set to 60 seconds and the post-stimulation assessment time is set to 60 seconds.

[0110] Program distribution and transcranial magnetic stimulation (TMS) program selection: The host computer software module distributes the configured signal acquisition program to the multimodal physiological signal acquisition terminal, and simultaneously redirects to the TMS program selection interface. Users can select stored stimulation programs as needed (e.g., target F4, intensity 80% of resting motion threshold, stimulation frequency 5Hz, stimulation time 2 seconds, interval time 8 seconds, cycle 10 seconds, repetition count 6 times), or perform operations to add new stimulation programs or modify existing programs, thus achieving personalized adaptation of stimulation programs.

[0111] Calibration testing and synchronization error compensation: The host computer software module sends the selected stimulation program to the transcranial magnetic stimulation device and synchronously records the delay data (e.g., 1 second) of the instruction being sent to receive the stimulation pulse from the transcranial magnetic stimulation device; to ensure synchronization, when the transcranial magnetic stimulation device start instruction is subsequently sent, the delay data (e.g., 1 second) is sent in advance to ensure the synchronous start and stop of the multimodal physiological signal acquisition terminal and the transcranial magnetic stimulation device, with an error in the millisecond range.

[0112] Initiation Assessment and Signal Synchronization Acquisition Marking: The host computer software module first sends a start command to the multimodal physiological signal acquisition terminal to initiate the pre-acquisition of physiological signals for 60 seconds before stimulation. When the pre-acquisition reaches 60 seconds of delayed data (e.g., 1 second), a start command is sent to the transcranial magnetic stimulation device to achieve precise synchronization between the physiological signals and the transcranial magnetic stimulation. During stimulation, after each repetition of stimulation, the host computer performs linear fitting on all troughs of the RR gap sequence and extracts the slope of the fitted line as a linear trend indicator of heart rate variability (e.g., the slopes of 6 repetitions of stimulation are -0.12, -0.06, -0.16, 0.33, 0.45, and 0.6, respectively). Simultaneously, it monitors blood oxygen saturation (e.g., stable at 98%) and respiratory rate (e.g., stable at 12 breaths / min) in real time. On the physiological signal waveform and heart rate (RR gap) waveform displayed on the host computer, the stimulation target label, stimulation start position, and stimulation end position are automatically marked.

[0113] Closed-loop feedback and manual adjustment: Throughout the stimulation evaluation process, the host computer continuously monitors the real-time calculated indicators (including the slope of the RR gap linear fitting). If an indicator is detected as not meeting expectations (e.g., the slope suddenly changes to 2.8 in the third of six repeated stimulations, and there is no noise interference in the ECG and pulse wave signals, ruling out abnormalities caused by signal interference), the user can choose the operation direction according to the prompts: If the user chooses to adjust the position of the stimulation coil, the host computer software module will send the positioning and pose adjustment instructions to the navigation robot, which will then perform precise adjustment of the coil position; if the user chooses to modify the stimulation parameters or stop the stimulation operation, the host computer software module will directly send the parameter adjustment or stop instructions to the transcranial magnetic stimulation device to complete the corresponding operation.

[0114] Therapeutic efficacy evaluation and analysis: After 6 repeated stimulations and an evaluation 60 seconds after stimulation, the system comprehensively analyzed the collected multimodal physiological signals and RR gap fitting data through the causal correlation analysis unit. The analysis results showed that as stimulation continued, the slope of the linear fitting of the RR gap sequence gradually increased, corresponding to a continuous increase in the RR gap, which in turn indicated a gradual decrease in heart rate. This suggests that the transcranial magnetic stimulation of the target point (F4) had a regulatory effect on reducing heart rate.

[0115] Evaluation Report Generation: The system automatically generates a complete evaluation report on the efficacy of stimulation. The report includes a heart rate change trend graph, stimulation target marking information, and full-cycle physiological evaluation index data before, during, and after stimulation (such as time-frequency domain and nonlinearity of heart rate variability before, during, and after stimulation), providing complete data support for stimulation efficacy analysis and subsequent stimulation program optimization.

[0116]

Claims

1. A transcranial magnetic stimulation medical system guided by multimodal physiological signals, comprising: The host computer software module, navigation robot, transcranial magnetic stimulation device, stimulation coil, stimulation pulse conversion module, multimodal physiological signal acquisition terminal, and physiological probe connected to the multimodal physiological signal acquisition terminal; The host computer software module interacts with the navigation robot, transcranial magnetic stimulation device, and multimodal physiological signal acquisition terminal to form command exchanges. The host computer software module includes: an inspection item unit, a data processing unit, and a scheme management unit; Its characteristic is that it also includes a synchronization control unit; The synchronization control unit is used to realize delay compensation and synchronous start-up and shutdown of the transcranial magnetic stimulation device and the multimodal physiological signal acquisition terminal.

2. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The stimulation pulse sampling rate of the transcranial magnetic stimulator is configured to be consistent with the sampling rate of the multimodal physiological signal acquisition terminal.

3. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 2, characterized in that: The sampling rate is configured and adjusted via host computer software.

4. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The synchronization control unit is built into the host computer software module.

5. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The data processing unit includes a time alignment unit and a causal correlation analysis unit; The time alignment unit is used to detect the first high-level start point of the stimulation pulse signal of the transcranial magnetic stimulation device, and mark the physiological signal position corresponding to the start point as the start position of the current stimulation cycle. The time alignment unit is used to count the number of high-level pulse signals. When the count value matches the preset value, the position of the physiological signal corresponding to the high level is marked as the end position of the current stimulation cycle. The causal correlation analysis unit is used to quantify the collected physiological signals and stimulation pulse signals, and analyze the correlation characteristics between the stimulation of the body by a transcranial magnetic stimulation device and the dynamic changes in the body's autonomic nervous function.

6. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The scheme management unit has built-in multimodal physiological signal acquisition scheme and transcranial magnetic stimulation scheme; The physiological signal acquisition scheme includes selecting which physiological signals to acquire and setting the acquisition duration; The transcranial magnetic stimulation protocol includes the selection of targets and parameters for various neurological diseases.

7. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The multimodal physiological signal acquisition terminal includes: an electrocardiogram signal acquisition module, a pulse wave signal acquisition module, a respiratory signal acquisition module, a skin conductance signal acquisition module, and a stimulation pulse receiving module; the start / stop and parameter configuration of each module can be uniformly managed and dynamically adjusted through host computer software.

8. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The host computer software module interacts with the navigation robot through first control commands and status feedback; the first control commands include: adjusting the position of the transcranial magnetic stimulation coil, locating the stimulation coil, and tracking the stimulation coil in real time. The host computer software module interacts with the transcranial magnetic stimulation device through a second control command and status feedback; the second control command includes: adjustment of stimulation parameters and start / stop of stimulation; The host computer software module interacts with the multimodal physiological signal acquisition terminal through a third control command and digital stimulation pulses and digital physiological signal feedback; the third control command includes starting and stopping the multimodal physiological signal acquisition terminal; the multimodal physiological signal acquisition terminal acquires human physiological signals through physiological probes; the physiological signals include: electrocardiogram signals, pulse wave signals, respiratory signals, and skin conductance signals.

9. The transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: The stimulation pulse conversion module converts the acquired stimulation coil pulse signal into a digital stimulation pulse signal; the digital stimulation pulse signal is transmitted to the multimodal physiological signal acquisition terminal via USB, and then fed back to the host computer software module. The multimodal physiological signal acquisition terminal converts the acquired physiological signals into digital signals.

10. A transcranial magnetic stimulation medical system guided by multimodal physiological signals according to claim 1, characterized in that: It also includes an assessment system, which includes a stimulation target assessment module, a stimulation parameter assessment module, and a stimulation efficacy assessment module. The stimulation target assessment module evaluates stimulation targets through the multimodal physiological signal-guided transcranial magnetic stimulation medical system. By analyzing the multimodal physiological signals and comparing the differences in the regulatory effects of different targets, the module assesses the regulatory effect of different transcranial magnetic stimulation targets on autonomic nerve function. The stimulation parameter evaluation module evaluates stimulation parameters through the multimodal physiological signal-guided transcranial magnetic stimulation medical system. By analyzing the multimodal physiological signals, it clarifies the regulatory effects of different stimulation parameters and then evaluates the regulatory effects of different transcranial magnetic stimulation parameters on autonomic nerve function. The stimulation efficacy assessment module evaluates the stimulation efficacy through the transcranial magnetic stimulation medical system guided by the multimodal physiological signals. It achieves full-cycle assessment before, during, and after stimulation through multimodal physiological signals, comprehensively reflecting the regulatory effect of the transcranial magnetic stimulation device on autonomic nerve function.

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