Method, device and system for testing limb tremor stimulator

Abstract

The invention discloses a testing method, device and system for a limb tremor stimulator. The testing method comprises the steps of collecting a first physiological signal of a patient based on a first testing period; determining a reference stimulation power value of the patient in a normal state based on the first physiological signal; based on preset stimulation parameters, the patient is stimulated through the limb tremor stimulator in a second test period; in a second test period, acquiring a second physiological signal of the patient based on the stimulation duration; determining a tremor suppression rate of the patient based on the second physiological signal and the reference stimulation power value; determining whether a preset test stop condition is satisfied based on the tremor suppression rate and a preset stimulation parameter; when a preset test stop condition is met, stopping the test and outputting a tremor stimulation test result; and determining stimulation parameters of the limb tremor stimulator based on a tremor stimulation test result. The method has the technical effect of improving the stimulation parameter configuration efficiency of the limb tremor stimulator.

Description

Technical Field

[0001] This disclosure relates to the field of limb tremor stimulation technology, and more particularly to a testing method, apparatus, and system for a limb tremor stimulator. Background Technology

[0002] With the continuous development of neuromodulation technology and wearable medical devices, adjunctive treatment devices for neurological diseases such as Parkinson's disease and essential tremor are emerging. Among them, limb tremor stimulators, as a non-invasive intervention, have shown preliminary efficacy in improving patients' tremor symptoms. These devices typically apply periodic mechanical or electrical stimulation to areas such as the forearm and wrist to intervene in the neuromuscular feedback pathway of tremor, thereby slowing down or controlling involuntary tremor movements. However, individual differences exist among patients (such as different tremor frequencies, tolerance levels, and muscle characteristics), therefore, the configuration of stimulation parameters for limb tremor stimulators deserves attention. Summary of the Invention

[0003] In view of this, embodiments of this application provide a testing method, apparatus, and system for a limb tremor stimulator, aiming to improve the efficiency of stimulator parameter configuration. Firstly, a testing method for a limb tremor stimulator is provided to determine the stimulation parameters of the limb tremor stimulator. The testing method includes: acquiring a patient's first physiological signal based on a first test cycle in a non-stimulated state of the limb tremor stimulator; determining a baseline stimulation power value for the patient in a normal state based on the first physiological signal; stimulating the patient with the limb tremor stimulator in a second test cycle based on preset stimulation parameters, wherein the stimulation parameters include: stimulation frequency, stimulation current, duration of the second test cycle, target tremor inhibition rate, or stimulation current test step size; acquiring the patient's second physiological signal based on the stimulation duration in the second test cycle; determining the patient's tremor inhibition rate based on the second physiological signal and the baseline stimulation power value; determining whether a preset test stop condition is met based on the tremor inhibition rate and the preset stimulation parameters, wherein the preset test stop condition is determined based on the duration of the second test cycle, the target tremor inhibition rate, and a safety threshold for the stimulation current; stopping the test and outputting the tremor stimulation test result when the preset test stop condition is met; continuing the test based on the preset stimulation parameters when the preset test stop condition is not met; and determining the stimulation parameters of the limb tremor stimulator based on the tremor stimulation test result.

[0004] The above-described testing method for limb tremor stimulators allows for dynamic adjustment of stimulation parameters based on the acquired second physiological signal feedback, eliminating the need for manual intervention and improving testing efficiency. Real-time monitoring of safety thresholds during testing ensures that the stimulation current does not exceed limits, guaranteeing patient safety. In clinical application, this allows for appropriate stimulation of patients with more ideal parameters, improving tremor stimulation efficacy, safety, and patient comfort. For example, the results of tremor stimulation tests can determine the current value or frequency that most significantly improves the tremor suppression rate, or select an appropriate stimulation current testing step size, thereby improving the efficiency of tremor stimulation therapy.

[0005] Optionally, when determining the stimulation parameters of the limb tremor stimulator, the following are included: the electromyography (EMG) collector is attached to the patient's ulnar extensor carpi ulnaris via electrode pads and the patient's index finger is clamped by a clamp; the EMG collector is configured to start the test after connecting to the test platform via Bluetooth; the limb tremor stimulator is configured to be worn close to the patient's wrist line and start the test after connecting to the test platform via Bluetooth.

[0006] Optionally, acquiring the patient's second physiological signal based on the stimulation duration further includes: performing bandpass filtering on the second physiological signal based on a preset filtering threshold, wherein the preset filtering threshold is determined based on the patient's typical tremor frequency.

[0007] Optionally, the tremor suppression rate of a patient is determined based on the second physiological signal and the baseline stimulation power value, including: determining the power spectral density of the second physiological signal within the preset time window based on the preset time window and the second physiological signal; identifying and determining the main tremor frequency based on the power spectral density, and calculating the tremor frequency power value of the main tremor frequency; and determining the tremor suppression rate based on the tremor frequency power value of the main tremor frequency and the baseline stimulation power value.

[0008] Optionally, based on the tremor inhibition rate and preset stimulation parameters, determine whether the preset test stop conditions are met, including: when the tremor inhibition rate is less than the target tremor inhibition rate and the current stimulation current is less than the stimulation current safety threshold, adjust the stimulation current based on the stimulation current test step size and continue testing; when the tremor inhibition rate is greater than or equal to the target tremor inhibition rate and the current stimulation current is less than the stimulation current safety threshold, maintain the stimulation parameters and continue testing until the preset test stop conditions are met.

[0009] Optionally, it also includes: when adjusting the stimulation current based on the stimulation current test step size, if the adjusted stimulation current is greater than the safety threshold, the preset test stop condition is met.

[0010] Optionally, it also includes: generating a test result graph based on the tremor stimulation test results, the test result graph including one or more of the following: a graph of the relationship between stimulation current and time, a graph of the relationship between tremor inhibition rate and time, or a graph of the relationship between tremor inhibition rate and stimulation current.

[0011] Secondly, a testing device for a limb tremor stimulator is provided for determining the stimulation parameters of the limb tremor stimulator. The testing device includes: a first stimulation unit for acquiring a patient's first physiological signal based on a first test cycle in a non-stimulated state of the limb tremor stimulator; a determination unit for determining a baseline stimulation power value for the patient in a normal state based on the first physiological signal; and a second stimulation unit for stimulating the patient with the limb tremor stimulator in a second test cycle based on preset stimulation parameters, wherein the stimulation parameters include: stimulation frequency, stimulation current, duration of the second test cycle, target tremor inhibition rate, or stimulation current test step size; and .... The positioning unit is also used in the second test cycle to acquire the patient's second physiological signal based on the stimulation duration; determine the patient's tremor inhibition rate based on the second physiological signal and the baseline stimulation power value; determine whether the preset test stop condition is met based on the tremor inhibition rate and preset stimulation parameters. The preset test stop condition is determined based on the duration of the second test cycle, the target tremor inhibition rate, and the safety threshold of the stimulation current; when the preset test stop condition is met, the test is stopped and the tremor stimulation test result is output; when the preset test stop condition is not met, the test continues based on the preset stimulation parameters; the output unit is used to determine the stimulation parameters of the limb tremor stimulator based on the tremor stimulation test result.

[0012] Thirdly, a testing system for a limb tremor stimulator is provided for determining the stimulation parameters of the limb tremor stimulator. The testing system includes: an electromyography (EMG) acquisition device configured to acquire physiological signals from a patient; a limb tremor stimulator configured to provide tremor stimulation to the patient; and a testing platform connected to the EMG acquisition device and the limb tremor stimulator, configured to determine the stimulation parameters of the limb tremor stimulator according to the testing method for the limb tremor stimulator provided in the first aspect.

[0013] Optionally, the testing platform is also configured to record test result graphs, test safety event records, and stimulation parameter combinations based on tremor stimulation test results, and form a historical test database. Attached Figure Description

[0014] The accompanying drawings used in the description of the embodiments of this disclosure are briefly introduced below:

[0015] Figure 1 This application provides a schematic diagram of the structure of a testing system for a limb tremor stimulator according to some embodiments;

[0016] Figure 2 A flowchart illustrating a testing method for a limb tremor stimulator provided in some embodiments of this application is shown.

[0017] Figure 3This document illustrates a flowchart of a method for determining a patient's tremor inhibition rate based on a second physiological signal and a baseline stimulation power value, provided in some embodiments of this application.

[0018] Figure 4 This illustration shows a schematic diagram of a stimulation current-time relationship provided in some embodiments of this application;

[0019] Figure 5 This paper illustrates a tremor suppression rate-time relationship provided in some embodiments of this application;

[0020] Figure 6 A flowchart illustrating a testing method for another limb tremor stimulator provided in some embodiments of this application is shown.

[0021] Figure 7 A testing apparatus for a limb tremor stimulator provided in some embodiments of this application is shown;

[0022] Figure 8 A schematic diagram of the structure of a test system for another limb tremor stimulator provided in some embodiments of this application is shown. Detailed Implementation

[0023] To more clearly illustrate the technical solutions in the embodiments of this disclosure, examples of implementation methods of this disclosure will be described below with reference to the accompanying drawings. The accompanying drawings described below are merely some embodiments of this disclosure. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort. Adjustments and improvements made without departing from the concept of this disclosure are all within the protection scope of this disclosure.

[0024] To keep the drawings simple, each figure only schematically shows the parts relevant to the embodiment, and they do not represent the actual structure of the product. In addition, for the sake of clarity and ease of understanding, some figures only schematically show parts of components with the same structure or function, and there may actually be more or fewer components with the same structure or function.

[0025] In this disclosure, unless otherwise expressly specified and limited, ordinal numbers, such as “first”, “second”, etc., are used only to distinguish and describe related objects, and should not be construed as indicating or implying the relative importance or order between related objects; furthermore, they do not represent the quantity of related objects. “Multiple” includes two or more, and other quantifiers are similar. “ / ” is used to describe the relationship between related objects, indicating an “or” relationship between them. “And / or” is used to describe the relationship between related objects, including any combination relationship between them, such as “a and / or b” including: “a alone”, “b alone”, or “a and b”. “One or more” or “at least one” of multiple objects refers to any object or any combination of multiple objects, such as “one or more of a1, a2, a3” or “at least one of a1, a2, a3” including: “a1 alone”, “a2 alone”, “a3 alone”, “a1 and a2”, “a1 and a3”, “a2 and a3”, or “a1, a2 and a3”.

[0026] With the continuous development of neuromodulation technology and wearable medical devices, adjunctive treatment devices for neurological diseases such as Parkinson's disease and essential tremor are emerging. Among them, upper limb tremor stimulators, as a non-invasive intervention, have shown preliminary efficacy in improving patients' tremor symptoms. These devices typically apply periodic mechanical or electrical stimulation to areas such as the forearm and wrist to intervene in the neuromuscular feedback pathway of tremor, thereby slowing down or controlling involuntary tremor movements. However, current testing methods for these devices remain relatively primitive. On the one hand, they rely on manual operation and visual assessment, with testers manually setting stimulation parameters and observing the wearer's tremor improvement. This method is highly subjective, has poor repeatability, is difficult to standardize, and is inefficient, failing to meet the needs of large-scale, systematic device testing. On the other hand, automated testing programs with preset parameters are used to automatically verify the stimulator's output behavior under fixed parameters, but this lacks real-time feedback pathways and cannot dynamically adjust stimulation parameters based on the patient's actual response after device application, thus making it difficult to simulate the interaction characteristics between the device and the human body in real-world clinical scenarios. Individual differences exist among patients, and limb tremor stimulators cannot determine the optimal stimulation parameter configuration to address these differences. This leads to low testing accuracy, long equipment validation cycles, and insufficient safety assessments, further limiting the widespread clinical application of these devices. Therefore, there is an urgent need for an adaptive closed-loop testing method and system based on real-time physiological signal feedback. To overcome the problems of low efficiency, subjective evaluation methods, and lack of feedback loop and individualized adaptation capabilities in existing testing methods, this invention provides a limb tremor stimulation testing method, device, and system. By collecting tremor-related physiological signals from the test subject, the stimulation parameters of the limb tremor stimulator are rationally adjusted and determined, thereby dynamically adapting to the individual differences in tremor characteristics of patients and improving the efficiency of stimulation parameter configuration for limb tremor stimulators.

[0027] The following description is in conjunction with the accompanying drawings:

[0028] Figure 1A schematic diagram of a testing system for a limb tremor stimulator provided in some embodiments of this application is shown. This testing system is used to determine the stimulation parameters of the limb tremor stimulator. The testing system includes: an electromyography (EMG) acquisition device 10, configured to acquire physiological signals from a patient (s); a limb tremor stimulator 20, configured to provide tremor stimulation to the patient (s); and a testing platform 30, connected to the EMG acquisition device 10 and the limb tremor stimulator 20, configured to acquire physiological signals from the patient (s) through the EMG acquisition device 10 and provide muscle stimulation to the patient (s) through the limb tremor stimulator 20 according to the stimulation parameters. During connection, one end of the EMG acquisition device 10 can be connected to an electrode pad via an electrode wire. The electrode pad is then placed near the extensor carpi ulnaris muscle on the patient (s), and the index finger is held in place by a clamp. The connection method can be specifically configured according to different brands and models of EMG acquisition devices 10. The limb tremor stimulator 20 can be worn on the wrist of the patient (s) at the two fingers, stimulating the radial and median nerves of the patient (s) through a common electrode and a conductive wristband electrode, thereby modulating the thalamic neural network. The testing platform 30 can connect to the electromyography (EMG) acquisition device 10 and the limb tremor stimulator 20 via wired or wireless means, such as establishing a connection through Bluetooth to search for the EMG acquisition device 10 and initiating the test. The testing platform 30 can be a fixed device, such as a computer, a dedicated testing terminal, or a fixed medical platform; it can also be a mobile device, such as a mobile phone or a dedicated mobile testing device; or it can be a cloud system, initiated and tested through software running on the electronic device, such as through a mobile application when running in the cloud. Based on the above limb tremor stimulation system, Figure 2 A flowchart illustrating a testing method for a limb tremor stimulator according to some embodiments of this application is shown. This testing method is used to determine the stimulation parameters of the limb tremor stimulator, and includes:

[0029] S210: Under the non-stimulatory state of the limb tremor stimulator, the patient's first physiological signal is collected based on the first test cycle;

[0030] S220: Determine the baseline stimulation power value of the patient in a normal state based on the first physiological signal;

[0031] S230: Based on preset stimulation parameters, the patient is stimulated by a limb tremor stimulator during the second test cycle. The stimulation parameters include: stimulation frequency, stimulation current, duration of the second test cycle, target tremor inhibition rate, or stimulation current test step size.

[0032] S240: In the second test cycle, the patient's second physiological signal is acquired based on the stimulation duration;

[0033] S250: Determines the patient's tremor suppression rate based on the second physiological signal and baseline stimulation power value;

[0034] S260: Based on the tremor inhibition rate and preset stimulation parameters, determine whether the preset test stop conditions are met. The preset test stop conditions are determined based on the duration of the second test cycle, the target tremor inhibition rate, and the safety threshold of the stimulation current.

[0035] S261: When the preset test stop condition is met, the test is stopped and the tremor stimulation test results are output;

[0036] S262: When the preset test stop condition is not met, continue the test based on the preset stimulus parameters;

[0037] S270: Determine the stimulation parameters of the limb tremor stimulator based on the results of the tremor stimulation test.

[0038] In the embodiments of the above-described limb tremor stimulator testing method, before the test begins, the patient (s) wears the limb tremor stimulator and connects it to the electromyography (EMG) signal acquisition device, placing the electrodes near the extensor carpi ulnaris muscle. Initially, a non-stimulated state is maintained. During the first test cycle, the EMG acquisition device 10 acquires the patient's first physiological signal. At this time, the limb tremor stimulator 20 is not operating. This first physiological signal can be the patient's EMG signal. This signal refers to the change in electrophysiological potential generated during muscle contraction or relaxation. When nerve impulses are transmitted to muscle fibers, causing changes in the muscle fiber membrane potential, microvolt-level electrical signal fluctuations are detected at the coil electrodes or surface electrodes. In the tremor test, the waveform of the first physiological signal reflects the tremor rhythm and amplitude of the patient's limb muscles, and is an important objective quantitative indicator that can be used to assess tremor intensity and stimulation inhibition effect. The testing platform 30 can quantify the average power corresponding to the main tremor frequency by performing spectrum and power analysis on the first physiological signal, and use this as the benchmark stimulation power value in subsequent inhibition effect evaluation. The first physiological signal is a physiological benchmark value obtained under a non-stimulated state, which can be used to determine whether the patient's physiological activity is abnormal. Furthermore, the testing platform 30 can activate the limb tremor stimulator 20 to stimulate the patient s in the second testing cycle using preset stimulation parameters. Stimulation can include electrical and mechanical stimulation, specifically referring to the controllable physical energy output by the limb tremor stimulator 20 to the patient s's limb (e.g., the wrist or forearm), with the aim of intervening in the muscle nerve circuit to reduce or inhibit tremors. Electrical stimulation can send a series of pulsed currents (e.g., square waves or bipolar currents) to the skin surface via electrodes. The current enters the lower motor nerves or muscle fibers, altering the firing rhythm of the muscle fibers, thereby reducing tremor signals from the central or peripheral nervous system. Mechanical stimulation (e.g., the limb tremor stimulator 20 uses vibration or pushing methods) can be achieved through periodic mechanical vibrations generated by a micro-vibration motor or piezoelectric actuator. The vibration frequency and amplitude can be equivalently mapped to the electrical stimulation parameters, interfering with tremor generation by altering the feedback loop of tendon and muscle receptors. The testing platform 30 can stimulate the muscle according to preset stimulation parameters. The stimulation frequency can be the repetition rate of the stimulation current pulse acting on the muscle (in Hz). For example, low-frequency stimulation below 50Hz tends to activate slower motor units, resulting in milder muscle contractions; high-frequency stimulation above 100Hz is more likely to produce fusion contractions of muscle fibers or rapid tremor-like interference, which helps to more strongly interrupt pathological tremor circuits. The magnitude of the stimulation current determines the depth of stimulation. The greater the stimulation current, the stronger the muscle fiber response, but at the same time, the pain or discomfort also increases. The technical solution of this application can gradually find the optimal current value between "sufficient tremor suppression" and "patient comfort" during testing.The duration of the second testing cycle can be specifically set based on testing experience, allowing for more thorough observation of the stabilizing effect of tremor suppression and the identification of a response curve for the ideal stimulation parameters. The target tremor suppression rate can be a pre-set ideal suppression level threshold during the testing process. When the tremor suppression rate reaches or exceeds this value, it can be determined that the current parameters can achieve a therapeutic effect. Since it is necessary to find the ideal stimulation current value during the stimulation process, by setting the stimulation current test step size, in each stimulation test cycle, when the target suppression effect is not achieved, the current intensity can be increased by this step size, so that the test results gradually tend towards the optimal stimulation current parameters. The stimulation current test step size can be the same, for example, increasing a fixed current value each time between the first and second stimulation durations; or it can be different, for example, increasing or decreasing the current value of the step size based on the tremor stimulation test results between the first and second stimulation durations. At the same time, safety must also be considered during the testing process. After each stimulation duration in the second testing cycle, it is necessary to determine whether the stimulation current in the next stimulation duration meets the safety threshold of the stimulation current, in order to improve the safety of the patient during the testing process. During the second test cycle, the test stops and the tremor stimulation test results are output when the preset test stop conditions are met. The preset test stop conditions may include reaching the duration of the second test cycle (e.g., if there are N stimulation durations in the second test cycle, the test stops after completing N stimulation durations); or reaching the target tremor inhibition rate; or continuing the test to obtain more test results, while meeting the safety threshold of the stimulation current, until the duration of the second test cycle is reached; or stopping the test when the stimulation current exceeds the safety threshold when adjusting the stimulation current by adjusting the stimulation current test step size. After the second test cycle is completed, the stimulation parameters of the limb tremor stimulator 20 can be determined based on the tremor stimulation test results. These tremor stimulation test results can be a set of result tables, showing the tremor inhibition rate of patient s under different stimulation parameters during the test. It can also be in graphical form, such as line graphs, bar charts, or pie charts, reflecting the changes in tremor suppression rate of patients under different stimulation parameters. This helps technicians explore and determine ideal stimulation parameters, improving the efficiency of limb tremor stimulator parameter setting. This application can dynamically adjust stimulation parameters through real-time feedback from acquired second physiological signals, without manual intervention, significantly improving testing efficiency. It also monitors safety thresholds in real-time during testing to ensure that the stimulation current does not exceed limits, guaranteeing patient safety. In clinical applications, it allows for more ideal stimulation parameters to provide appropriate stimulation to patients, improving tremor stimulation effectiveness, stimulation safety, and patient comfort.For example, based on the results of tremor stimulation tests, the current value or frequency that most significantly improves the tremor suppression rate can be determined, or an appropriate stimulation current test step size can be selected, thereby improving the efficiency of tremor stimulation therapy.

[0039] In some embodiments of this application, obtaining the patient's second physiological signal based on the stimulation duration further includes: bandpass filtering the second physiological signal based on a preset filtering threshold, wherein the preset filtering threshold is determined based on the patient's typical tremor frequency.

[0040] This application allows for bandpass filtering of the second physiological signal to extract frequency components directly related to tremor and suppress other interferences. The preset filtering threshold can be determined during the pre-experiment or medical history assessment phase, setting upper and lower limits based on the subject's typical tremor frequency range, such as 4Hz to 6Hz. Alternatively, it can consider physiological differences among patients, appropriately widening the upper and lower limits by ±1Hz, for example, setting them to a range of 3Hz to 7Hz. A digital bandpass filter can be set in the electromyography (EMG) acquisition device 10, such as a second-order filter or a finite impulse response filter, and a filtering algorithm can be designed using the window function method or bilinear transform to input the entire acquired second physiological signal into the EMG acquisition device 10. By using the patient's typical tremor frequency as the passband, accurately retaining the target tremor signal, and eliminating irrelevant low-frequency body movements and high-frequency noise, the accuracy of tremor power calculation can be improved.

[0041] Figure 3 The diagram illustrates a flowchart of a method for determining a patient's tremor suppression rate based on a second physiological signal and a baseline stimulation power value, provided in some embodiments of this application. The method includes:

[0042] S310: Based on a preset time window and a second physiological signal, determine the power spectral density of the second physiological signal within the preset time window;

[0043] S320: Determine the main flutter frequency based on power spectral density identification, and calculate the flutter frequency power value of the main flutter frequency;

[0044] S330: Determine the tremor inhibition rate based on the tremor frequency power value and the baseline stimulus power value of the dominant tremor frequency.

[0045] In the above embodiments, after acquiring the second physiological signal, the power spectral density of the second physiological signal can be determined based on a preset time window. For example, the second physiological signal is divided into frames according to a preset time window of 1 second, and a preset overlap ratio can be set between windows. A window function and a fast Fourier transform are used to multiply the data of each time window by a Hanning window to reduce spectral leakage, and a fast Fourier transform is further used to calculate the amplitude at each frequency point. For power spectral density estimation, the Welch method can be used to square the amplitude of each frame and take the average to obtain the power spectral density curve within the time window. Simultaneously, within a preset tremor frequency bandwidth, a peak point is found from the power spectral density curve; the frequency corresponding to this peak is the main tremor frequency. The power value of the power spectral density curve at the main tremor frequency is then read out and recorded as the tremor frequency power value of the current main tremor frequency. Therefore, the current tremor suppression rate can be calculated and determined using Formula 1:

[0046]

[0047] Wherein, TSR represents the tremor suppression rate, Baseline_power represents the baseline stimulation power value, and P_current represents the tremor frequency power value of the main tremor frequency.

[0048] In some embodiments of this application, determining whether a preset test stop condition is met based on the tremor inhibition rate and preset stimulation parameters includes: when the tremor inhibition rate is less than the target tremor inhibition rate and the current stimulation current is less than the stimulation current safety threshold, adjusting the stimulation current based on the stimulation current test step size to continue testing; when the tremor inhibition rate is greater than or equal to the target tremor inhibition rate and the current stimulation current is less than the stimulation current safety threshold, maintaining the stimulation parameters to continue testing until the preset test stop condition is met.

[0049] To obtain as many results as possible about the relationship between tremor inhibition rate, stimulation current, and time under different stimulation parameters in the tremor stimulation test, the stimulation current can be continuously adjusted during the second testing cycle to obtain tremor stimulation test results, while ensuring safety during the testing process. When the tremor inhibition rate is less than the target tremor inhibition rate, the relationship between the current stimulation current and the safe threshold of the stimulation current is assessed. If it is within the safe threshold range, the test can continue. Simultaneously, the adjusted stimulation current can be set to remain within the safe threshold in the next stimulation duration. Furthermore, even if it is determined that the current tremor inhibition rate is greater than or equal to the target tremor inhibition rate, as long as the stimulation current remains within the safe threshold, the test can continue to obtain more test results. Since different stimulation currents may produce different tremor inhibition states in patients, it does not mean that a larger stimulation current will result in better tremor inhibition. In fact, increasing the stimulation current may fail to meet the target tremor inhibition rate. Furthermore, it's possible that the tremor suppression rate can significantly increase even with the same stimulation current test step size adjustment. For example, increasing the stimulation current from 0.4mA to 0.5mA might only increase the tremor suppression rate by 5%, while increasing it from 0.5mA to 0.6mA might increase it by 20%. Therefore, obtaining as many test results as possible can help technicians find the optimal stimulation current parameters, improve the efficiency of parameter setting for the limb tremor stimulator 20, and further enhance the clinical treatment effect on patients.

[0050] In some embodiments of this application, the method further includes: when adjusting the stimulation current based on the stimulation current test step size, if the adjusted stimulation current is greater than a safety threshold, a preset test stop condition is met.

[0051] In some embodiments of this application, the method further includes: generating a test result graph based on the tremor stimulation test results, wherein the test result graph includes one or more of the following: a graph showing the relationship between stimulation current and time, a graph showing the relationship between tremor inhibition rate and time, or a graph showing the relationship between tremor inhibition rate and stimulation current.

[0052] To make the tremor stimulation test results more readable and easier to analyze, various forms of test result graphs can be generated using the testing platform 30. For example... Figure 4 A schematic diagram of a stimulation current-time relationship provided in some embodiments of this application is shown. Figure 4 The horizontal axis represents the test time, and the vertical axis represents the stimulation current intensity, displaying the trajectory of the stimulation current over time throughout the closed-loop test. This allows for intuitive observation of the current adjustment steps and termination point. Alternatively... Figure 5 A schematic diagram illustrating a tremor suppression rate-time relationship provided in some embodiments of this application is shown. Figure 5The graph uses the horizontal axis to represent test time and the vertical axis to represent tremor inhibition rate, showing the dynamic trend of the inhibition rate as the stimulation duration increases, reflecting the response speed and stability of the inhibition effect. Alternatively, a tremor inhibition rate-stimulation current relationship graph can be generated, with the horizontal axis representing stimulation current intensity and the vertical axis representing tremor inhibition rate, displaying inhibition efficiency curves under different stimulation currents, helping to quickly locate the minimum effective current and the inflection point of therapeutic effect. These graphs can be generated individually or combined and displayed side-by-side on the same interface. Technicians can select the curve type to view through the legend. Key data points can be marked, such as marking when the target inhibition rate is reached, and the raw data and fitted curves can also be exported together. Based on the above tremor stimulation test results, key indicators can be output, such as the time to first reach the target tremor inhibition rate, the current at which the target tremor inhibition rate is first reached, the average tremor inhibition rate throughout the test, the peak value of the tremor inhibition rate during the test, the stability maintenance rate (the percentage of time greater than the target tremor inhibition rate), the consumption of stimulation current during the test (the change in current during the period of reaching the target tremor inhibition rate), and the change in the patient's skin impedance (the increase in skin impedance with electrode changes). From the above test results, those skilled in the art can determine the optimal combination of stimulation parameters, for example, finding the combination of stimulation parameters that has the highest percentage of time with a tremor inhibition rate greater than 60% within 30 minutes and the lowest current consumption, and considering this the optimal combination.

[0053] In some embodiments of this application, Figure 6 This application illustrates another method for testing a limb tremor stimulator provided in some embodiments, the method specifically including:

[0054] S601: Acquire the first physiological signal and calculate the baseline stimulation power value.

[0055] S602: Set the initial stimulation parameters: stimulation current I = 5mA, stimulation frequency F = 50Hz.

[0056] S603: Activate the limb tremor stimulator;

[0057] S604: Real-time acquisition of second physiological signals;

[0058] S605: Calculate the tremor suppression rate;

[0059] S606: Determine whether the calculated tremor suppression rate meets the target tremor suppression rate; if the tremor suppression rate is greater than or equal to the target tremor suppression rate, proceed to step S607; if it is less than the target tremor suppression rate, proceed to step S611.

[0060] S607: Maintain stimulation parameters;

[0061] S608: Continuous monitoring;

[0062] S609: Determine whether the second test cycle has been reached; if not, proceed to step S604; if so, proceed to step S610.

[0063] S610: Generates a test result report, including: target tremor suppression rate-current curve, optimal parameter combination, and safety event record.

[0064] S611: Adjust the stimulation current according to the stimulation current test step size;

[0065] S612: Send a stimulation current command and continue to execute step S603.

[0066] The specific explanations and beneficial effects of the above test methods and steps for the tremor stimulator can be found in the embodiments provided above, and will not be elaborated upon here. In some embodiments, the stimulation parameters may also include parameters such as the waveform mode and pulse width of the stimulation current. For example, the waveform mode may adopt a biphasic rectangular, phase interference, or sinusoidal modulation mode, and the pulse width can also be set by setting the stimulation current pulse width test step size. The stimulation current pulse width is changed for testing within different test durations in the second test cycle. Through the test result report, those skilled in the art can optimize and retest the equipment. For example, based on the tremor suppression rate-current relationship curve and safety events, the equipment problem can be accurately located, such as unstable output at a certain current level or poor effect at a certain frequency, and hardware or software optimization can be performed. After optimization, the equipment is put back into the test system of the limb tremor stimulator, and the test reports before and after optimization are compared to verify the optimization effect. Historical test data is stored in the test platform for longitudinal comparison.

[0067] Based on the same technological concept Figure 7This application illustrates a testing apparatus for a limb tremor stimulator according to some embodiments, used to determine the stimulation parameters of the limb tremor stimulator. The testing apparatus 700 includes: a first stimulation unit 710, used to acquire a first physiological signal of a patient based on a first test cycle in a non-stimulated state of the limb tremor stimulator; a determination unit 720, used to determine a baseline stimulation power value of the patient in a normal state based on the first physiological signal; and a second stimulation unit 730, used to stimulate the patient with the limb tremor stimulator in a second test cycle based on preset stimulation parameters, wherein the stimulation parameters include: stimulation frequency, stimulation current, duration of the second test cycle, target tremor inhibition rate, or stimulation current. The flow test step size; the determination unit 720 is also used to acquire the patient's second physiological signal based on the stimulation duration in the second test cycle; determine the patient's tremor inhibition rate based on the second physiological signal and the baseline stimulation power value; determine whether the preset test stop condition is met based on the tremor inhibition rate and preset stimulation parameters, the preset test stop condition is determined based on the duration of the second test cycle, the target tremor inhibition rate and the safety threshold of the stimulation current; when the preset test stop condition is met, the test is stopped and the tremor stimulation test result is output; when the preset test stop condition is not met, the test continues based on the preset stimulation parameters; the output unit 740 is used to determine the stimulation parameters of the limb tremor stimulator based on the tremor stimulation test result.

[0068] The above division of units is merely a logical functional division. In actual implementation, they can be fully or partially integrated into a single physical entity, or they can be physically separated. Furthermore, the above units can be implemented by a processor calling software; for example, a limb tremor stimulator testing device includes a processor connected to a memory containing instructions. The processor calls the instructions stored in the memory to implement any of the above methods or to realize the functions of each unit. The processor can be, for example, a general-purpose processor, such as a central processing unit (CPU), and the memory can be internal or external to the device. Alternatively, the above units can be implemented as hardware circuits. The functions of some or all units can be realized through the design of the hardware circuit, which can be understood as one or more processors. For example, in some embodiments, the hardware circuit is an application-specific integrated circuit (ASIC), and the functions of some or all units are realized through the design of the logical relationships between the components within the circuit. In another implementation, the hardware circuit can be implemented using a programmable logic device (PLD), which can include a large number of logic gates. The logical relationships between the logic gates are configured through a configuration file, thereby realizing the functions of some or all units. All units of the above devices can be implemented entirely through processor calling programs, or entirely through hardware circuits, or partially through processor calling programs with the remaining parts implemented through hardware circuits.

[0069] Continue to refer to Figure 1 A testing system and testing platform for a limb tremor stimulator are provided, which are connected to an electromyography (EMG) acquisition device and a limb tremor stimulator and are configured to determine the stimulation parameters of the limb tremor stimulator according to the testing method for the limb tremor stimulator provided in the above embodiments.

[0070] In some implementations, the test platform 30 is also configured to record test result graphs, test safety event records, and stimulation parameter combinations based on the tremor stimulation test results, and to form a historical test database.

[0071] In some implementations... Figure 8A schematic diagram of a testing system for another limb tremor stimulator provided in some embodiments of this application is shown. The testing system includes a limb tremor stimulator 810 and an electromyography (EMG) acquisition unit 820. The limb tremor stimulator 810 includes a first power module 811 for supplying power to the limb tremor stimulator 810. A stimulation module 812 is used to stimulate the limb via a wristband w worn on the upper limb through a pulse generation and detection module 813 according to test instructions from a test platform 30, and to acquire a second physiological signal from the upper limb through an inertial measurement module 815. The test instructions, the second physiological signal, and other data information can be transmitted to the test platform 30 via a first Bluetooth module 814. Furthermore, the limb tremor stimulator 810 can be manually controlled via a first button module 816 to enable its on / off function or other functions. The EMG acquisition unit 820 includes a second power module 821 for supplying power to the EMG acquisition unit 820. The acquisition and processing module 822 can acquire the first physiological signal through the acquisition electrode n set on the upper limb of the human body. The testing platform 30 can acquire the first physiological signal through the second Bluetooth module 823 or send acquisition or testing commands to the acquisition and processing module 822. In addition, the switch or other functions of the electromyography acquisition device 820 can be manually controlled through the second button module 824.

[0072] In the above embodiments, the descriptions of each embodiment have their own emphasis. Parts not described in detail or in a particular embodiment can be referred to in the relevant descriptions of other embodiments. Furthermore, the above embodiments can be freely combined as needed.

Claims

1. A testing method for a limb tremor stimulator, characterized in that, The testing method for determining the stimulation parameters of a limb tremor stimulator includes: In the non-stimulation state of the limb tremor stimulator, the patient's first physiological signal is collected based on the first test cycle; The baseline stimulation power value of the patient under normal conditions is determined based on the first physiological signal; Based on preset stimulation parameters, the patient is stimulated by the limb tremor stimulator during the second test cycle. The stimulation parameters include: stimulation frequency, stimulation current, duration of the second test cycle, target tremor inhibition rate, or stimulation current test step size. During the second test cycle, the patient's second physiological signal is acquired based on the stimulation duration; The patient's tremor suppression rate is determined based on the second physiological signal and the baseline stimulation power value; Based on the tremor suppression rate and the preset stimulation parameters, it is determined whether the preset test stop condition is met. The preset test stop condition is determined based on the duration of the second test cycle, the target tremor suppression rate, and the safety threshold of the stimulation current. When the preset test stop condition is met, the test is stopped and the tremor stimulation test results are output. If the preset test stop condition is not met, the test continues based on the preset stimulus parameters; The stimulation parameters of the limb tremor stimulator are determined based on the results of the tremor stimulation test.

2. The testing method for the limb tremor stimulator according to claim 1, characterized in that, Determining the stimulation parameters of the limb tremor stimulator includes: The electromyography (EMG) acquisition device is attached to the patient's ulnar extensor carpi ulnaris via electrode pads, and the patient's index finger is clamped by a clamp. The electromyography (EMG) acquisition device is configured to start the test after connecting to the test platform via Bluetooth; The limb tremor stimulator is configured to be worn close to the patient's wrist line and the test is initiated after being connected to the test platform via Bluetooth.

3. The testing method for the limb tremor stimulator according to claim 1, characterized in that, The method of acquiring the patient's second physiological signal based on stimulation duration also includes: The second physiological signal is bandpass filtered based on a preset filtering threshold, which is determined based on the patient's typical tremor frequency.

4. The testing method for the limb tremor stimulator according to claim 1, characterized in that, Determining the patient's tremor suppression rate based on the second physiological signal and the baseline stimulation power value includes: Based on a preset time window and the second physiological signal, the power spectral density of the second physiological signal within the preset time window is determined; The main flutter frequency is determined based on the power spectral density, and the flutter frequency power value of the main flutter frequency is calculated. The tremor suppression rate is determined based on the tremor frequency power value of the dominant tremor frequency and the reference stimulation power value.

5. The testing method for the limb tremor stimulator according to claim 1, characterized in that, The step of determining whether a preset test stop condition is met based on the tremor suppression rate and the preset stimulation parameters includes: When the tremor suppression rate is less than the target tremor suppression rate and the current stimulation current is less than the stimulation current safety threshold, the stimulation current is adjusted based on the stimulation current test step size and the test continues. When the tremor suppression rate is greater than or equal to the target tremor suppression rate, and the current stimulation current is less than the stimulation current safety threshold, the stimulation parameters are maintained and the test continues until the preset test stop condition is met.

6. The testing method for the limb tremor stimulator according to claim 5, characterized in that, Also includes: When the stimulation current is adjusted based on the stimulation current test step size, if the adjusted stimulation current is greater than the safety threshold, the preset test stop condition is met.

7. The testing method for the limb tremor stimulator according to claim 1, characterized in that, Also includes: Based on the tremor stimulation test results, a test result graph is generated, which includes one or more of the following: a graph showing the relationship between the stimulation current and time, a graph showing the relationship between the tremor inhibition rate and time, or a graph showing the relationship between the tremor inhibition rate and the stimulation current.

8. A testing device for a limb tremor stimulator, characterized in that, The testing device, used to determine the stimulation parameters of a limb tremor stimulator, includes: The first stimulation unit is used to collect the patient's first physiological signal based on a first test cycle in the non-stimulation state of the limb tremor stimulator. A determining unit is configured to determine the baseline stimulation power value of the patient under normal conditions based on the first physiological signal; The second stimulation unit is used to stimulate the patient through the limb tremor stimulator during the second test cycle based on preset stimulation parameters, wherein the stimulation parameters include: stimulation frequency, stimulation current, duration of the second test cycle, target tremor inhibition rate, or stimulation current test step size. The determining unit is further configured to, during the second test cycle, acquire the patient's second physiological signal based on the stimulation duration; determine the patient's tremor inhibition rate based on the second physiological signal and the baseline stimulation power value; determine whether a preset test stop condition is met based on the tremor inhibition rate and the preset stimulation parameters, the preset test stop condition being determined based on the duration of the second test cycle, the target tremor inhibition rate, and the safety threshold of the stimulation current; when the preset test stop condition is met, stop the test and output the tremor stimulation test result; when the preset test stop condition is not met, continue the test based on the preset stimulation parameters. The output unit is used to determine the stimulation parameters of the limb tremor stimulator based on the tremor stimulation test results.

9. A testing system for a limb tremor stimulator, characterized in that, The testing system, used to determine the stimulation parameters of a limb tremor stimulator, includes: An electromyography (EMG) acquisition device is configured to acquire physiological signals from patients. A limb tremor stimulator is configured to provide tremor stimulation to the patient. A testing platform, connected to the electromyography (EMG) acquisition device and the limb tremor stimulator, is configured to determine the stimulation parameters of the limb tremor stimulator according to any one of claims 1 to 7.

10. The testing system for the limb tremor stimulator according to claim 9, characterized in that, The testing platform is also configured to record test result graphs, test safety event records, and stimulation parameter combinations based on the tremor stimulation test results, and to form a historical test database.

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