A neural stimulation regulation system and method for dual-task gated taVNS

Abstract

The present application relates to the technical field of neuromodulation, and discloses a neuromodulation system and method for dual-task gated taVNS. The present application collects kinematic data and cognitive performance data of a patient performing a motor-cognitive dual task; obtains an objective maximum load paradigm according to the kinematic data and the cognitive performance data, obtains a subjective maximum load paradigm according to a subjective work load score, and combines the two to obtain a maximum intensity dual-task load paradigm; applies multiple trial dual-task training to the patient under the maximum intensity dual-task load paradigm, and in each trial, determines in real time whether to trigger transcutaneous auricular vagus nerve stimulation according to a dual-dimension gating condition, triggers to generate a stimulation signal when the cognitive correctness condition and the motor safety condition are both satisfied, and suspends the presentation of a new task during the stimulation duration. The present application realizes precise coupling of dual-task training and neuromodulation in the time dimension, and improves the timing specificity and individualization of neuromodulation.

Description

Technical Field

[0001] This invention relates to the field of neuromodulation technology, and discloses a dual-task gated taVNS neural stimulation modulation system and method. Background Technology

[0002] Percutaneous vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, activates the locus coeruleus-norepinephrine system by stimulating the auricular branch of the vagus nerve located in the concha and tragus regions. It has shown potential in the treatment of epilepsy, depression, tinnitus, and post-stroke sequelae. Current taVNS techniques generally employ a fixed-parameter open-loop stimulation model, meaning the application of stimulation is completely disconnected from the patient's current behavioral and cognitive state, failing to address the core question of "when to apply stimulation for maximum effectiveness." Some studies have attempted to combine taVNS with single-task training, but the training methods are mostly single motor or single cognitive tasks, without considering the impact of cognitive-motor resource competition on neural plasticity under dual-task conditions.

[0003] However, while motor-cognitive dual-task training has been used clinically as an independent rehabilitation method, it has never been precisely coupled with neuromodulation techniques in the temporal dimension, lacking a complete technical solution that integrates the two. Furthermore, animal studies have revealed that vagal nerve stimulation can only overcome the bottleneck in rehabilitation effects when motor or cognitive performance approaches the individual's capacity limits. However, existing equipment cannot quantify the intensity of individualized dual tasks, identify when a subject reaches their "maximum sustainable load," or precisely trigger stimulation within this critical window. Existing closed-loop stimulation protocols primarily rely on endogenous physiological signals, such as EEG and heart rate variability feedback, lacking gating triggering mechanisms based on exogenous behavioral performance. Summary of the Invention

[0004] The main objective of this invention is to address the aforementioned technical problems by providing a dual-task-gated taVNS neural stimulation modulation system and method, comprising: A dual-task-gated taVNS neural stimulation modulation system, the system comprising: The data acquisition module is used to collect the patient's kinematic data in each trial when the patient performs a motor-cognitive dual task, and to obtain the patient's cognitive performance data at each difficulty level. The kinematic data includes: leg lifting speed and knee vertical displacement; the cognitive performance data includes the digit recall error rate at different difficulty levels and the scores of all dimensions of the NASA-TLX scale. The assessment module is used to obtain the objective maximum workload paradigm of patients in motor-cognitive dual tasks based on their kinematic and cognitive performance data; to obtain subjective workload scores based on cognitive performance data; and to obtain the subjective maximum workload paradigm based on the subjective workload scores; and to combine the objective maximum workload paradigm and the subjective maximum workload paradigm to obtain the maximum intensity dual task workload paradigm. The training module is used to apply multiple trials of dual-task training to patients under the maximum intensity dual-task load paradigm. In each trial, it determines in real time whether the patient triggers percutaneous vagus nerve stimulation based on dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When the dual-dimensional gating conditions are met simultaneously, a stimulation signal of a preset duration is generated.

[0005] Furthermore, the method for obtaining the objective maximum load paradigm includes: When a patient performs a motor-cognitive dual task each time, the difficulty of the current motor-cognitive dual task is taken as the objective maximum load paradigm when the following three conditions are met: The decrease in leg lift speed compared to the preset kinematic data baseline is no less than 10%; the decrease in knee joint vertical displacement compared to the preset kinematic data baseline is no less than 10%; and the digit memory error rate is no less than 10%. The preset kinematic data baseline is the kinematic data when the patient answers completely correctly at the preset initial difficulty level.

[0006] Further, a subjective workload score is obtained based on the cognitive performance data, and a subjective maximum workload paradigm is obtained based on the subjective workload score, including: After all trials at each difficulty level are completed, obtain the scores of all dimensions of the NASA-TLX scale corresponding to that difficulty level, and calculate the average as the subjective workload score corresponding to that difficulty level. A subjective workload score curve is constructed with the number of digits corresponding to the difficulty level as the horizontal axis and the subjective workload score corresponding to each difficulty level as the vertical axis. The first derivative of each digit in the curve is calculated. The number of digits corresponding to the maximum value of the first derivative is taken as the subjective maximum workload paradigm.

[0007] Furthermore, by combining the objective maximum load paradigm with the subjective maximum load paradigm, a maximum intensity dual-task load paradigm is obtained, including: The maximum intensity dual-task load paradigm is obtained by taking the arithmetic average of the number of digits corresponding to the objective maximum load paradigm and the subjective maximum load paradigm, and then rounding down.

[0008] Furthermore, the dual-dimensional gating conditions include a cognitive correctness condition and a motor safety condition; when both dual-dimensional gating conditions are simultaneously met, a stimulus signal of a preset duration is triggered, including: The exercise safety conditions are that, when the patient performs a single exercise-cognitive dual task, the decrease in leg lifting speed compared to the preset kinematic data baseline is less than 10%, and the decrease in knee joint vertical displacement compared to the preset kinematic data baseline is less than 10%. The cognitive correctness condition is that the patient can recall the digits of the current position completely correctly when performing a single motor-cognitive dual task. A stimulus signal of a preset duration is generated only if the motion safety condition and the cognitive correctness condition are simultaneously satisfied.

[0009] Furthermore, the preset time length is set to 60 seconds.

[0010] Furthermore, it also includes a TTL hardware trigger interface, which is used by the cognitive task presentation software to directly trigger the taVNS stimulation device through the TTL hardware trigger interface when the two-dimensional gating conditions are simultaneously met, with a trigger delay of no more than 300 milliseconds.

[0011] A method for neural stimulation modulation of dual-task-gated taVNS, the method comprising: When patients perform a motor-cognitive dual task, kinematic data of patients are collected in each trial to obtain cognitive performance data of patients at each difficulty level; the kinematic data includes: leg lifting speed and vertical displacement of the knee joint; the cognitive performance data includes digit recall error rate at different digit gradients and scores of all dimensions of the NASA-TLX scale; Based on the patient's kinematic data and cognitive performance data, the objective maximum workload paradigm for the patient during motor-cognitive dual tasks is obtained; the subjective workload score is obtained based on the cognitive performance data, and the subjective maximum workload paradigm is obtained based on the subjective workload score; the objective maximum workload paradigm and the subjective maximum workload paradigm are combined to obtain the maximum intensity dual-task workload paradigm. Under the maximum intensity dual-task load paradigm, the patient is subjected to multiple trials of dual-task training. In each trial, the patient is judged in real time whether percutaneous vagus nerve stimulation is triggered based on dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When the dual-dimensional gating conditions are met simultaneously, a stimulation signal of a preset duration is triggered.

[0012] The beneficial effects of this invention are as follows: Compared to existing open-loop stimulation and single-behavior gating, this invention, for the first time, constructs a real-time gating mechanism based on dual-task motor safety and cognitive correctness, triggering taVNS only when the patient completes the dual tasks with high quality under extreme load. The evaluation module obtains objective and subjective maximum load paradigms based on kinematic and cognitive performance data, combining them to obtain the maximum intensity dual-task load paradigm, providing an individualized task difficulty benchmark for the training module. Under this paradigm, the training module applies multiple trials of dual-task training to the patient. In each trial, it makes real-time judgments based on a two-dimensional gating condition consisting of cognitive correctness and motor safety conditions, triggering the generation of a stimulus signal of a preset duration only when both conditions are simultaneously met. During the stimulus duration, the presentation of new task events is paused, and the next dual-task training begins after the stimulus ends. This invention achieves precise temporal coupling between dual-task training and neural modulation, improving the temporal specificity and individualization of neural modulation. Attached Figure Description

[0013] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a block diagram of a dual-task-gated taVNS neural stimulation modulation system according to an embodiment of the present invention; Figure 2 This is a flowchart of a neural stimulation modulation method for dual-task gated taVNS in an embodiment of the present invention. Detailed Implementation

[0014] Exemplary embodiments of the invention will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limiting the invention to the embodiments set forth herein. Rather, these exemplary embodiments are provided to make the invention more comprehensive and complete, and to facilitate a full communication of the inventive concept to those skilled in the art. The same reference numerals in the drawings denote the same or similar elements, components, or parts, and therefore repeated descriptions of them will be omitted.

[0015] Subject to the technical concept of this invention, the features, structures, characteristics or other details described in a particular embodiment may be combined in one or more other embodiments in a suitable manner.

[0016] In the description of specific embodiments, the features, structures, characteristics, or other details described in this invention are intended to enable those skilled in the art to fully understand the embodiments. However, it is not excluded that those skilled in the art can practice the technical solutions of this invention without one or more of the specific features, structures, characteristics, or other details.

[0017] The flowcharts shown in the accompanying drawings are merely illustrative and do not necessarily include all content and operations / steps, nor do they necessarily have to be performed in the described order. For example, some operations / steps can be broken down, while others can be combined or partially combined; therefore, the actual execution order may change depending on the specific circumstances.

[0018] The block diagrams shown in the accompanying drawings are merely functional entities and do not necessarily correspond to physically independent entities. That is, these functional entities can be implemented in software, in one or more hardware modules or integrated circuits, or in different network and / or processor devices and / or microcontroller devices.

[0019] The terms “and / or” or “and / or” include all combinations of any one or more of the listed items.

[0020] See Figure 1 This embodiment describes a dual-task gated taVNS neural stimulation modulation system, which includes a data acquisition module 101, an evaluation module 102, and a training module 103. The specific steps are as follows: Data acquisition module 101: When the patient performs the motor-cognitive dual task, it collects the patient's kinematic data in each trial and obtains the patient's cognitive performance data at each difficulty level; the kinematic data includes: leg lifting speed and knee joint vertical displacement; the cognitive performance data includes the digit recall error rate at different difficulty levels and the scores of all dimensions on the NASA-TLX scale.

[0021] When patients perform motor-cognitive dual tasks, their brains compete for resources. This can lead to situations where patients improve memory accuracy by slowing down or stopping their steps, or decrease their accuracy by focusing on their own motor state. Therefore, in this embodiment of the invention, kinematic and cognitive performance data of patients in motor-cognitive dual tasks are collected to facilitate subsequent analysis of the patient's optimal training intensity.

[0022] In one embodiment of the present invention, the kinematic data includes: leg lift speed and knee joint vertical displacement; the cognitive performance data includes the error rate of digit recall at different difficulty levels and the scores of all dimensions of the NASA-TLX scale.

[0023] An inertial measurement unit (IMU) was fitted to both knees of the patient and connected to the IMU in the computer via Bluetooth. Kinematic data was collected from the patient during a dual motor-cognitive task. To capture the dynamic changes in stepping movements without distortion and to allow sufficient time for subsequent two-dimensional gating condition determination and TTL triggering, the sampling frequency of the IMU was set to 100Hz, i.e., kinematic data was collected every 10ms. The patient's digit span test was performed using E-Prime software on the computer. The operator recorded the patient's verbal recall results and assessed their accuracy using E-Prime software, calculating the digit recall error rate at different difficulty levels. The scores for all dimensions of the NASA-TLX scale at each difficulty level were also recorded.

[0024] In each motor-cognitive dual-task trial, the kinematic data acquisition window starts when the digit sequence begins to appear and stops when the patient completes verbal recall and the operator confirms the answer. The average value of all leg-lifting velocities and all knee joint vertical displacements acquired within the acquisition window is used as the leg-lifting velocities and knee joint vertical displacements for that trial, thus effectively avoiding judgment errors caused by instantaneous fluctuations in stepping movements.

[0025] In one embodiment of the present invention, the specific calculation steps for the leg lift velocity and knee joint vertical displacement in the kinematic data are as follows: The raw acceleration signal output by the inertial measurement unit is filtered, with a cutoff frequency set to 20Hz to eliminate high-frequency noise. The vertical displacement is obtained by double integration of the filtered vertical acceleration. The landing event of each step cycle is detected based on the minimum point of the vertical displacement, thus dividing the leg lift phase. Within each leg lift phase, the maximum vertical velocity is taken as the leg lift velocity for each step. The leg lift velocity of each trial is obtained by taking the arithmetic mean of the leg lift velocities of all steps included in a trial. The peak value of the vertical displacement of the knee joint within each leg lift phase is taken as the vertical displacement of the knee joint for each step. The vertical displacement of the knee joint of all steps within a trial is taken as the average value to obtain the vertical displacement of the knee joint for that trial.

[0026] After all trials at each difficulty level were completed, the digit recall error rate in the cognitive performance data was calculated. Each difficulty level contained a preset number of sets of random digit sequences. The preset initial difficulty was set to 4 digits, and the number of digits increased by 1 step as the difficulty increased. The digit recall error rate was the number of trials in which the patient answered incorrectly divided by the total number of trials for the corresponding difficulty level. At a given difficulty level, if the patient made any error in digits, omissions, or incorrect digit order, that trial was recorded as an error. The NASA-TLX scale score in the cognitive performance data was also obtained after all trials at each difficulty level. Immediately after completing all trials at each difficulty level, patients completed the NASA-TLX scale, rating each of the six dimensions—mental need, physical need, time need, task performance, effort, and frustration—within a range of 0-100 points to ensure that the subjective rating reflected the immediate experience at that specific difficulty level and to avoid recall bias.

[0027] In one embodiment of the present invention, the preset number of groups is set to 10. It should be noted that the preset number can be set by the implementer according to the specific implementation scenario, and is not limited here.

[0028] Assessment module 102: Based on the patient's kinematic data and cognitive performance data, obtain the patient's objective maximum workload paradigm during motor-cognitive dual tasks; obtain a subjective workload score based on the cognitive performance data, and obtain a subjective maximum workload paradigm based on the subjective workload score; combine the objective maximum workload paradigm and the subjective maximum workload paradigm to obtain the maximum intensity dual-task workload paradigm.

[0029] If only cognitive performance is used to determine whether a patient has triggered a stimulus, the patient may strategically sacrifice motor quality to preserve cognitive performance. Conversely, if only motor performance is used to determine whether a patient has triggered a stimulus, the patient may reduce the effort required for digit recall to ensure motor quality. Therefore, in this embodiment of the invention, the objective maximum load paradigm of the patient during motor-cognitive dual tasks is obtained based on the patient's kinematic data and cognitive performance data.

[0030] Preferably, in one embodiment of the present invention, the method for obtaining the objective maximum load paradigm includes: When a patient performs a motor-cognitive dual task each time, the difficulty of the current motor-cognitive dual task is taken as the objective maximum load paradigm when the following three conditions are met: The leg lift speed decreased by no less than 10% compared to the preset kinematic data baseline; the knee joint vertical displacement decreased by no less than 10% compared to the preset kinematic data baseline; and the digit memory error rate was no less than 10%. It should be noted that 10% was selected in this embodiment of the invention because 10% is a significant change relative to the normal fluctuation range (usually less than 5%), which can reliably reflect the real decline caused by task difficulty, and at the same time, it observes the patient's bottleneck period before obvious movement deformation or cognitive collapse occurs.

[0031] The preset kinematic data baseline is the kinematic data of the patient when they answer all questions correctly at a preset initial difficulty level. In this embodiment of the invention, the preset kinematic data baseline needs to be collected before formally entering the step-by-step incremental test. Baseline collection is performed at the preset initial difficulty level. At this difficulty level, a preset number of random number sequences are presented to the patient, and kinematic data for each task is collected simultaneously. The average value of all correctly answered kinematic data is taken as the preset kinematic data baseline only if and only if the digit recall error rate for all tasks at the preset initial difficulty level is 0%.

[0032] The NASA-TLX scale comprises six dimensions: mental workload, physical workload, time workload, task performance, effort level, and frustration level. It is a widely used multidimensional subjective workload assessment tool internationally. Therefore, in this embodiment of the invention, a subjective workload score is obtained based on the NASA-TLX score in the cognitive performance data, and a subjective maximum workload paradigm is obtained based on the subjective workload score.

[0033] Preferably, in one embodiment of the present invention, obtaining a subjective workload score based on the cognitive performance data, and obtaining a subjective maximum workload paradigm based on the subjective workload score, includes: After all trials at each difficulty level are completed, obtain the scores of all dimensions on the NASA-TLX scale corresponding to that difficulty level, and calculate the average to obtain the subjective workload score corresponding to that difficulty level.

[0034] Using the number of digits corresponding to each difficulty level as the horizontal axis and the subjective workload score corresponding to each difficulty level as the vertical axis, all data points are plotted and connected in a two-dimensional coordinate system to construct a subjective workload score curve.

[0035] Starting from the second difficulty level, the first-order difference quotient between the subjective workload score corresponding to each difficulty level and the subjective workload score corresponding to the previous difficulty level is calculated as the subjective workload increment for each difficulty level; the digit corresponding to the maximum subjective workload increment is taken as the subjective maximum workload paradigm. The maximum subjective workload increment indicates that the patient's psychological endurance has approached its maximum.

[0036] Preferably, in one embodiment of the present invention, the objective maximum load paradigm is combined with the subjective maximum load paradigm to obtain a maximum intensity dual-task load paradigm, including: To ensure the safety of subsequent training phases, the maximum intensity dual-task load paradigm is obtained by arithmetically averaging the number of digits corresponding to the objective maximum load paradigm and the subjective maximum load paradigm, and then rounding down. This maximum intensity dual-task load paradigm is then used as the input parameter for subsequent training modules.

[0037] Training module 103: Under the maximum intensity dual-task load paradigm, the patient is subjected to multiple trials of dual-task training. In each trial, the patient is judged in real time whether percutaneous vagus nerve stimulation is triggered according to dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When the dual-dimensional gating conditions are met simultaneously, a stimulation signal of a preset duration is triggered.

[0038] This module applies precise neuromodulation to patients based on the maximum intensity dual-task load paradigm determined by the assessment module.

[0039] Before training begins, the system loads the maximum intensity dual-task load paradigm determined by the evaluation module, as well as the preset kinematic data baseline. The basic stimulation parameters of the taVNS stimulation device are set as follows: frequency 25Hz, pulse width 250µs, and stimulation target points are the left concha and tragus.

[0040] In one embodiment of the present invention, the intensity of electrical stimulation for each patient is measured. The measurement method is as follows: starting from 0.5mA, the current intensity is increased in increments of 0.5mA. The current value when the patient first feels a slight tingling sensation in the ear is recorded as the sensory threshold, and the current value when the patient indicates that he cannot tolerate it is recorded as the pain threshold. The final stimulation intensity is set to the midpoint between the sensory threshold and the pain threshold, and does not exceed 5mA.

[0041] The training phase consists of multiple independent trials, each of which is a complete dual-task execution and judgment unit. Since the maximal-intensity dual-task load paradigm reflects the critical range of a patient's cognitive-motor abilities, patients sometimes complete the motor-cognitive dual tasks at the difficulty level corresponding to the maximal-intensity dual-task load paradigm, and sometimes fail, indicating that this difficulty level represents the training window with the strongest neuroplasticity in patients.

[0042] Each trial includes the following process: The E-Prime software presents a random sequence of numbers corresponding to the maximum intensity dual-task load paradigm in the center of the screen; the patient steps at a constant speed under the guidance of a metronome and memorizes the numbers; after a preset delay, the patient verbally recalls the numbers; the E-Prime software records whether the answer is correct; the inertial measurement unit synchronously collects the leg lifting speed and knee joint vertical displacement of the trial, the collection window starts when the number sequence is presented and stops when the verbal recall is confirmed, and the average value within the window is taken as the representative value of the kinematic data of the trial.

[0043] In one embodiment of the present invention, the preset time is set to 4 seconds. It should be noted that the preset time can be set by the implementer according to the specific implementation scenario, and is not limited here.

[0044] Based on the Hebbian plasticity principle, enhanced neural connectivity depends on temporal consistency, meaning that neural activity and modulation signals must occur synchronously. Applying multiple trials of dual-task training to patients under the aforementioned maximum-intensity dual-task load paradigm significantly enhances neural plasticity. Therefore, in each trial, the triggering of percutaneous vagus nerve stimulation is determined in real-time based on dual-dimensional gating conditions.

[0045] Preferably, in one embodiment of the present invention, the dual-dimensional gating conditions include a cognitive correctness condition and a movement safety condition; when the dual-dimensional gating conditions are simultaneously satisfied, a stimulus signal of a preset duration is triggered, including: The exercise safety conditions are that, when the patient performs a single exercise-cognitive dual task, the decrease in leg lifting speed compared to the preset kinematic data baseline is less than 10%, and the decrease in knee joint vertical displacement compared to the preset kinematic data baseline is less than 10%. The cognitive correctness condition is that the patient can recall the digits of the current position completely correctly when performing a single motor-cognitive dual task. A stimulus signal of a preset duration is generated only if the motion safety condition and the cognitive correctness condition are simultaneously satisfied.

[0046] When both gating conditions are met simultaneously, the E-Prime software sends a trigger signal to the taVNS stimulation device via the TTL hardware trigger interface, with a trigger delay of no more than 300 milliseconds. Upon receiving the trigger signal, the taVNS stimulation device initiates stimulation according to preset stimulation parameters, lasting for 60 seconds. The preset duration is 60 seconds.

[0047] It is important to note that, to ensure the patient is not disturbed by new tasks during stimulation, and to allow the neuromodulation effects induced by taVNS to fully act on the neural pathways activated by the successfully completed task without being diluted or interfered with by neural activity induced by subsequent tasks, the presentation of new task events is paused during the 60-second stimulation period. Only after the stimulation ends does the E-Prime software present the numerical sequence for the next task, initiating a new trial. If the two-dimensional gating conditions for a trial are not simultaneously met, no stimulation signal is generated, and the process directly proceeds to the next dual-task training.

[0048] In summary, this system comprises three modules: a data acquisition module 101, used to collect the patient's kinematic data in each trial while the patient performs a motor-cognitive dual task, and to obtain the patient's cognitive performance data at each difficulty level; the kinematic data includes: leg lifting speed and knee joint vertical displacement; the cognitive performance data includes the digit recall error rate at different difficulty levels and scores for all dimensions of the NASA-TLX scale; and an evaluation module 102, used to obtain the patient's objective maximum load paradigm during the motor-cognitive dual task based on the patient's kinematic data and cognitive performance data; and to evaluate the patient's cognitive performance based on the cognitive performance data. The system obtains a subjective workload score from the current data and then derives a subjective maximum workload paradigm based on the subjective workload score. The objective maximum workload paradigm is combined with the subjective maximum workload paradigm to obtain a maximum intensity dual-task workload paradigm. A training module 103 is used to apply multiple trials of dual-task training to the patient under the maximum intensity dual-task workload paradigm. In each trial, the module determines in real time whether the patient triggers percutaneous vagus nerve stimulation based on dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When both dual-dimensional gating conditions are simultaneously met, a stimulation signal of a preset duration is generated.

[0049] The second objective of this invention is to provide a method for neural stimulation modulation of dual-task gated taVNS, specifically including: When patients perform a motor-cognitive dual task, kinematic data of patients are collected in each trial to obtain cognitive performance data of patients at each difficulty level; the kinematic data includes: leg lifting speed and vertical displacement of the knee joint; the cognitive performance data includes digit recall error rate at different digit gradients and scores of all dimensions of the NASA-TLX scale; Based on the patient's kinematic data and cognitive performance data, the objective maximum workload paradigm for the patient during motor-cognitive dual tasks is obtained; the subjective workload score is obtained based on the cognitive performance data, and the subjective maximum workload paradigm is obtained based on the subjective workload score; the objective maximum workload paradigm and the subjective maximum workload paradigm are combined to obtain the maximum intensity dual-task workload paradigm. Under the maximum intensity dual-task load paradigm, the patient is subjected to multiple trials of dual-task training. In each trial, the patient is judged in real time whether percutaneous vagus nerve stimulation is triggered based on dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When the dual-dimensional gating conditions are met simultaneously, a stimulation signal of a preset duration is triggered.

[0050] Program code for performing the operations of this invention can be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java and C++, and conventional procedural programming languages ​​such as C or similar languages. The program code can execute entirely on the user's computing device, partially on the user's device, as a standalone software package, partially on the user's computing device and partially on a remote computing device, or entirely on a remote computing device or server. In cases involving remote computing devices, the remote computing device can be connected to the user's computing device via any type of network, including a local area network (LAN) or a wide area network (WAN), or it can be connected to an external computing device (e.g., via the Internet using an Internet service provider).

[0051] In summary, the present invention can be implemented in hardware, or as software modules running on one or more processors, or a combination thereof. Those skilled in the art will understand that in practice, general-purpose data processing devices such as microprocessors or digital signal processors (DSPs) can be used to implement some or all of the functions of some or all of the components according to the embodiments of the present invention. The present invention can also be implemented as a device or apparatus program (e.g., a computer program and computer program product) for performing part or all of the methods described herein. Such programs implementing the present invention can be stored on a computer-readable medium or can be in the form of one or more signals. Such signals can be downloaded from an Internet website, provided on a carrier signal, or provided in any other form.

[0052] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the present invention is not inherently related to any specific computer, virtual device, or electronic device, and various general-purpose devices can also implement the present invention. The above descriptions are merely specific embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

[0053] The various embodiments in this specification are described in a progressive manner. The same or similar parts between the various embodiments can be referred to each other. Each embodiment focuses on describing the differences from other embodiments.

[0054] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A neural stimulation modulation system for dual-task gated taVNS, characterized in that, The system includes: The data acquisition module is used to collect the patient's kinematic data in each trial when the patient performs a motor-cognitive dual task, and to obtain the patient's cognitive performance data at each difficulty level. The kinematic data includes: leg lifting speed and knee joint vertical displacement. The cognitive performance data includes the digit recall error rate at different difficulty levels and the scores of all dimensions on the NASA-TLX scale. The assessment module is used to obtain the patient's objective maximum workload paradigm during motor-cognitive dual tasks based on the patient's kinematic data and cognitive performance data; to obtain a subjective workload score based on the cognitive performance data, and to obtain a subjective maximum workload paradigm based on the subjective workload score; and to combine the objective maximum workload paradigm with the subjective maximum workload paradigm to obtain a maximum intensity dual-task workload paradigm. The training module is used to apply multiple trials of dual-task training to the patient under the maximum intensity dual-task load paradigm. In each trial, it determines in real time whether the patient triggers percutaneous vagus nerve stimulation based on dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When the dual-dimensional gating conditions are met simultaneously, a stimulation signal of a preset duration is triggered.

2. The neural stimulation modulation system for dual-task gated taVNS according to claim 1, characterized in that, The method for obtaining the objective maximum load paradigm includes: When a patient performs a motor-cognitive dual task each time, the difficulty of the current motor-cognitive dual task is taken as the objective maximum load paradigm when the following three conditions are met: The decrease in leg lift speed compared to the preset kinematic data baseline is no less than 10%; the decrease in knee joint vertical displacement compared to the preset kinematic data baseline is no less than 10%; and the digit memory error rate is no less than 10%. The preset kinematic data baseline is the kinematic data when the patient answers completely correctly at the preset initial difficulty level.

3. The neural stimulation modulation system for dual-task gated taVNS according to claim 1, characterized in that, A subjective workload score is obtained based on the cognitive performance data, and a subjective maximum workload paradigm is obtained based on the subjective workload score, including: After all trials at each difficulty level are completed, obtain the scores of all dimensions of the NASA-TLX scale corresponding to that difficulty level, and calculate the average as the subjective workload score corresponding to that difficulty level. A subjective workload score curve is constructed with the number of digits corresponding to the difficulty level as the horizontal axis and the subjective workload score corresponding to each difficulty level as the vertical axis. The first derivative of each digit in the curve is calculated. The number of digits corresponding to the maximum value of the first derivative is taken as the subjective maximum workload paradigm.

4. The neural stimulation modulation system for dual-task gated taVNS according to claim 1, characterized in that, Combining the objective maximum load paradigm with the subjective maximum load paradigm yields the maximum intensity dual-task load paradigm, including: The maximum intensity dual-task load paradigm is obtained by taking the arithmetic mean of the number of digits corresponding to the objective maximum load paradigm and the subjective maximum load paradigm, and then rounding down.

5. The neural stimulation modulation system for dual-task gated taVNS according to claim 1, characterized in that, The dual-dimensional gating conditions include cognitive correctness conditions and motion safety conditions; When both gating conditions are met simultaneously, a stimulus signal of a preset duration is generated, including: The exercise safety conditions are that, when the patient performs a single exercise-cognitive dual task, the decrease in leg lifting speed compared to the preset kinematic data baseline is less than 10%, and the decrease in knee joint vertical displacement compared to the preset kinematic data baseline is less than 10%. The cognitive correctness condition is that the patient can recall the digits of the current position completely correctly when performing a single motor-cognitive dual task. A stimulus signal of a preset duration is generated only if the motion safety condition and the cognitive correctness condition are simultaneously satisfied.

6. The neural stimulation modulation system for dual-task gated taVNS according to claim 1, characterized in that, Set the preset time length to 60 seconds.

7. The neural stimulation modulation system for dual-task gated taVNS according to claim 1, characterized in that, It also includes a TTL hardware trigger interface, which is used by the cognitive task presentation software to directly trigger the taVNS stimulation device through the TTL hardware trigger interface when the two-dimensional gating conditions are met simultaneously, with a trigger delay of no more than 300 milliseconds.

8. A method for neural stimulation modulation of dual-task-gated taVNS, characterized in that, The method includes: When patients perform a motor-cognitive dual task, kinematic data of patients are collected in each trial to obtain cognitive performance data of patients at each difficulty level; the kinematic data includes: leg lifting speed and vertical displacement of the knee joint; the cognitive performance data includes digit recall error rate at different digit gradients and scores of all dimensions of the NASA-TLX scale; Based on the patient's kinematic data and cognitive performance data, the objective maximum workload paradigm for the patient during motor-cognitive dual tasks is obtained; the subjective workload score is obtained based on the cognitive performance data, and the subjective maximum workload paradigm is obtained based on the subjective workload score; the objective maximum workload paradigm and the subjective maximum workload paradigm are combined to obtain the maximum intensity dual-task workload paradigm. Under the maximum intensity dual-task load paradigm, the patient is subjected to multiple trials of dual-task training. In each trial, the patient is judged in real time whether percutaneous vagus nerve stimulation is triggered based on dual-dimensional gating conditions. The dual-dimensional gating conditions include cognitive correctness conditions and motor safety conditions. When the dual-dimensional gating conditions are met simultaneously, a stimulation signal of a preset duration is triggered.

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