Nerve regulation and control device and method integrating transcranial stimulation and resonance respiration

Abstract

The invention relates to the field of medical apparatus and instruments, and provides a nerve regulation and control device and method fusing transcranial stimulation and resonance respiration in order to improve the stimulation effect, a resonance frequency evaluation module based on personalization is adopted to identify the resonance respiration frequency based on individuals, and the individual difference of respiration regulation and control is weakened; during fusion regulation and control, on one hand, real-time respiration-heartbeat signal feedback is performed to help an individual to optimize a respiration mode, and on the other hand, transcranial stimulation during resonance respiration can realize accurate intervention of targeted vagus nerve stimulation, so that the stimulation effect is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a neuroregulatory device and method integrating transcranial stimulation and resonant breathing. Background Art

[0002] Existing relevant studies have confirmed that vagus nerve-related stimulation has therapeutic value for patients with mood disorders. In the prior art, for example, the invention patent application with publication number CN 117839074A discloses a binaural synchronous closed-loop vagus nerve electrical stimulator with real-time monitoring of HRV (heart rate variability), which triggers binaural transcutaneous vagus nerve stimulation in combination with the physiological characteristics of breathing, maximizes the excitement of the awakening center, and achieves a wake-up effect. However, the literature points out that the effect of applying stimulation in combination with the inhalation / exhalation moment under the natural breathing state is not significant in improving cognitive, emotional and other behaviors. Under the natural breathing state, the individual breathing pattern is changeable and the internal physiological state is difficult to control, resulting in exogenous stimulation at the key moment of natural breathing action. It may not achieve the optimal effect of stimulating the vagus nerve. Summary of the invention

[0003] In order to improve the stimulation effect, the present application provides a neuromodulatory device and method that integrates transcranial stimulation and resonant breathing.

[0004] The technical solution adopted by the present invention to solve the above problems is:

[0005] A neuromodulatory device that integrates transcranial stimulation and resonant breathing, including:

[0006] ECG monitoring module: used to collect ECG signals;

[0007] Respiration monitoring module: used to collect respiratory signals;

[0008] Data analysis module: obtains the respiratory signal curve and respiratory frequency based on the respiratory signal, obtains the heartbeat signal curve based on the electrocardiogram signal, and calculates the phase synchronization based on the respiratory signal curve and the heartbeat signal curve to obtain the phase difference between the respiratory signal curve and the heartbeat signal curve;

[0009] Breathing training module: guides the subject to adjust the breathing frequency according to the phase difference between the breathing signal curve and the heartbeat signal curve calculated in real time;

[0010] Individualized resonant frequency evaluation module: before stimulation, the individual resonant respiratory frequency is evaluated based on the ECG signal and respiratory signal collected during the respiratory training. The individual resonant respiratory frequency is the respiratory frequency when the phase difference between the respiratory signal curve and the heartbeat signal curve is equal to A;

[0011] Interaction module: guides the subject to adjust the breathing frequency according to the difference between the real-time collected breathing frequency and the individual resonant breathing frequency;

[0012] Transcranial stimulation module: When the real-time acquired respiratory frequency is the same as the individual resonant respiratory frequency, stimulation is performed according to the preset stimulation parameters.

[0013] Further, A is 0-30°.

[0014] Furthermore, the interaction module and the breathing training module both include a voice prompt unit and / or a display unit.

[0015] Furthermore, the interaction module is also used to set preset stimulation parameters.

[0016] Furthermore, the preset stimulation parameters include stimulation mode, stimulation intensity, stimulation position and / or stimulation frequency.

[0017] Furthermore, the ECG monitoring module uses three-lead ECG electrodes to collect ECG signals, and the respiratory monitoring module uses a chest-strap respiratory belt to collect respiratory signals.

[0018] Furthermore, the stimulation of the transcranial stimulation module is electrical stimulation.

[0019] A neuromodulation approach that combines transcranial stimulation and resonant breathing, including:

[0020] Step 1: Before stimulation, collect the subject's ECG and respiratory signals;

[0021] Step 2: construct a respiratory signal curve based on the collected respiratory signal and perform peak detection, calculate the time interval between adjacent peaks to obtain the respiratory frequency; perform ECG R peak detection on the collected ECG signal, calculate the time interval between adjacent R peaks, and form a heartbeat sequence from the time interval to obtain a heartbeat signal curve; perform phase synchronization calculation based on the respiratory signal curve and the heartbeat signal curve to obtain the phase difference between the respiratory signal curve and the heartbeat signal curve;

[0022] Step 3, guiding the subject to adjust breathing, and determining the breathing frequency when the phase difference between the breathing signal curve and the heartbeat signal curve is equal to A as the individual resonant breathing frequency;

[0023] Step 4: Collect the subject's ECG signal and respiratory signal in real time;

[0024] Step 5, guiding the subject to adjust the breathing frequency according to the difference between the real-time breathing frequency and the individual resonant breathing frequency;

[0025] Step 6: When the real-time respiratory frequency is the same as the individual resonant respiratory frequency, stimulation is performed according to the preset stimulation parameters.

[0026] Furthermore, in step 3 and step 5, the subject is guided to adjust the breathing rate through voice and / or display.

[0027] Furthermore, in step 6, the preset stimulation parameters are determined according to the basic characteristics of the subject.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The fusion resonance breathing and transcranial stimulation regulation technology proposed in this invention optimizes the stimulation scheme to a certain extent, weakens individual differences, and provides physiological objective evaluation indicators, which is expected to provide additive regulation effects and is a novel neural regulation technology. Specifically:

[0030] (1) In terms of individual differences, a personalized resonance frequency assessment module is used to identify individual resonant breathing frequencies to weaken individual differences in respiratory regulation. During fusion regulation, real-time feedback is provided to help individuals optimize their breathing patterns, thus achieving endogenous intervention that precisely targets the vagus nerve from the bottom up.

[0031] (2) In terms of the spatial location of stimulation, the prefrontal cortex, which has a direct physiological connection with the vagus nerve, is targeted, which solves the problem of unnecessary stimulation to other brain regions and achieves precise top-down regulation of the vagus nerve pathway. In terms of stimulation intensity, an individualized stimulation threshold level is used to adapt to individual needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A schematic diagram of the structure of a neural control device integrating transcranial stimulation and resonant breathing;

[0033] Figure 2 A flow chart of the neuromodulation method integrating transcranial stimulation and resonant breathing;

[0034] Figure 3 This is a schematic diagram of the feedback interface;

[0035] Figure 4 Figure 2 shows the breathing signal curve and the heartbeat signal curve when the phase difference is 0° and 180°. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0037] like Figure 1 As shown, the neuromodulation device integrating transcranial stimulation and resonance breathing comprises:

[0038] ECG monitoring module: used to collect ECG signals, which can be collected using three-lead ECG electrodes.

[0039] Respiratory monitoring module: used to collect respiratory signals, and a chest strap respiratory device can be used to collect respiratory signals.

[0040] Data analysis module: obtain the respiratory signal curve and respiratory frequency based on the respiratory signal, obtain the heartbeat signal curve based on the ECG signal, and perform phase synchronization calculation based on the respiratory signal curve and the heartbeat signal curve to obtain the phase difference between the respiratory signal curve and the heartbeat signal curve. Specifically: construct the respiratory signal curve based on the collected respiratory signal and perform peak detection, calculate the time interval between adjacent peaks to obtain the respiratory frequency; perform ECG R peak detection on the collected ECG signal, calculate the time interval between adjacent R peaks, and form a heartbeat sequence from the time interval to obtain the heartbeat signal curve; perform phase synchronization calculation based on the respiratory signal curve and the heartbeat signal curve to obtain the phase difference between the respiratory signal curve and the heartbeat signal curve.

[0041] Breathing training module: guides the subject to adjust the breathing frequency according to the phase difference between the breathing signal curve and the heartbeat signal curve calculated in real time.

[0042] Individualized resonant frequency evaluation module: Before stimulation, the individual resonant respiratory frequency is evaluated based on the ECG signal and respiratory signal collected during the respiratory training. The individual resonant respiratory frequency is the respiratory frequency when the phase difference between the respiratory signal curve and the heartbeat signal curve is equal to A. In the actual test process, it is difficult to make the phase difference equal to a specific value. Therefore, A in this application is a range of 0-30°.

[0043] Interaction module: guides the subject to adjust the breathing frequency according to the difference between the real-time collected breathing frequency and the individual resonant breathing frequency.

[0044] Both the breathing training module and the interactive module may include a voice prompting unit and / or a display unit, which prompts the subject to adjust the breathing frequency through voice, or directly displays the individual resonant breathing frequency and the current breathing frequency on the display unit so that the subject can adjust the breathing frequency.

[0045] Transcranial stimulation module: When the real-time collected respiratory frequency is the same as the individual resonant respiratory frequency, stimulation is performed according to the preset stimulation parameters. The transcranial stimulation module can use electrical stimulation, magnetic stimulation and / or ultrasonic stimulation. The preset stimulation parameters include stimulation mode, stimulation intensity, stimulation position and / or stimulation frequency. The specific values ​​can be set according to the basic characteristics of the subject, including age, gender, individual emotional disorder characteristics, etc. The modification of the preset stimulation parameters can be achieved through the interactive module.

[0046] The present application also provides a neural regulation method integrating transcranial stimulation and resonant breathing, such as Figure 2As shown, taking electrical stimulation as an example, the entire experimental regulation process lasted for 20 days, and behavioral scales were completed before and after the experiment to evaluate whether the state of the test subjects was improved after two-way regulation and the degree of improvement.

[0047] Specifically, before the formal experiment begins, the State-Trait Anxiety Inventory (STAI) and the Resilience Subjective Rating Scale (CD-RISC) are used to assess the initial state of the test subjects. The STAI questionnaire assesses the anxiety state, and the CD-RISC assesses resilience.

[0048] On the first day of the experiment, the subjects wore a breathing belt and three-lead ECG electrodes to monitor their breathing and ECG data. During the breathing training, the collected ECG and breathing signals were sent to the data analysis module for calculation and analysis, and the test subjects were guided to adjust their breathing. The individual resonant breathing frequency was determined through the individualized resonant frequency evaluation module.

[0049] In order to facilitate the subjects to adjust their breathing rate, a feedback interface is provided, such as Figure 3 As shown in the figure, the feedback interface mainly includes the synchronous presentation of the breathing signal and the ECG signal, as well as the phase difference between the breathing signal and the heartbeat signal. When the phase difference is 0°, it means that the breathing signal and the heartbeat signal are completely synchronized, that is, the degree of inhalation is exactly the same as the degree of heartbeat increase, and the degree of exhalation is exactly the same as the degree of heartbeat decrease. When the phase difference is 180°, it means that the heart rate decreases when inhaling and increases when exhaling, which is the opposite of the phase difference of 0°. Figure 4 The breathing signal curve and heartbeat signal curve are shown when the phase difference is 0° and 180° respectively.

[0050] On the second day of the experiment, respiratory signals and ECG signals were collected and analyzed synchronously, and the subjects were guided to reach and maintain the breathing state based on the assessed individual resonant breathing frequency. At the same time, corresponding transcranial electrical stimulation was applied when the individual resonant breathing frequency was reached. Eight electrical stimulation schemes were set up in the system, including: for tDCS, the anode was placed at the F3 / F4 position, and the cathode was placed above the contralateral eye socket, that is, the Fp2 / Fp1 position; for tACS, one electrode was placed at the F3 / F4 position, and the other electrode was placed above the contralateral eye socket, that is, the Fp2 / Fp1 position; electrical stimulation was divided into direct current stimulation and three types of alternating current stimulation of 6Hz, 10Hz, and 40Hz. The experimental groups with different stimulation schemes were recorded as F3-tDCS, F4-tDCS, F3-40, F4-40, F3-10, F4-10, F3-6, and F4-6, respectively. The intensity of the stimulation current was set according to the individual conditions of the subjects, with 40Hz alternating current as the test current, starting from the overall intensity of 1mA and increasing or decreasing according to the subjects' feelings, ensuring that the subjects did not experience discomfort symptoms such as phosphenes, severe pain or strong burning sensations, while maintaining the maximum current intensity (no more than 2mA) to ensure the stimulation effect. The determined current intensity was used as the current intensity in the direct current stimulation and alternating current stimulation experiments for the subject. During the entire electrical stimulation process, the subjects were guided and maintained resonant breathing within a certain range, and the entire two-way regulation process lasted for 20 minutes.

[0051] From the third day to the twenty-first day of the experiment, the subjects continued to undergo the same two-way regulation as on the second day. The entire two-way regulation experiment lasted for 20 days.

[0052] After the experiment, in terms of subjective measurement, the State-Trait Anxiety Inventory (STAI) and the Subjective Scale for Resilience (CD-RISC) were used to assess whether the subjects' emotional state and resilience level had improved after the adjustment. A large number of experiments have shown that after the application of the stimulation method, the subjects' emotional state and resilience level have improved to a certain extent.

[0053] Bottom-up breathing regulation at a resonant frequency can maximize HRV, and vagus nerve control is further enhanced in a state of cardiopulmonary resonance, thereby inducing the highest amplitude of heartbeat oscillations. Transcranial electrical stimulation of the prefrontal cortex can effectively enhance parasympathetic nerve activity from top to bottom, thereby reducing overall heart rate and increasing HRV. By integrating transcranial electrical stimulation technology with the technology for maximizing endogenous vagus nerve activity stimulation - resonant breathing, to achieve endogenous and exogenous fusion stimulation of the vagus nerve-based interoceptive pathway, the transmission of information in the interoceptive pathway can be optimized, thereby better improving emotional state.

Claims

1. A neuromodulatory device integrating transcranial stimulation and resonant breathing, characterized in that: include: ECG monitoring module: used to collect ECG signals; Respiration monitoring module: used to collect respiratory signals; Data analysis module: obtains the respiratory signal curve and respiratory frequency based on the respiratory signal, obtains the heartbeat signal curve based on the electrocardiogram signal, and calculates the phase synchronization based on the respiratory signal curve and the heartbeat signal curve to obtain the phase difference between the respiratory signal curve and the heartbeat signal curve; Breathing training module: guides the subject to adjust the breathing frequency according to the phase difference between the breathing signal curve and the heartbeat signal curve calculated in real time; Individualized resonant frequency evaluation module: before stimulation, the individual resonant respiratory frequency is evaluated based on the ECG signal and respiratory signal collected during the respiratory training. The individual resonant respiratory frequency is the respiratory frequency when the phase difference between the respiratory signal curve and the heartbeat signal curve is equal to A; Interaction module: guides the subject to adjust the breathing frequency according to the difference between the real-time collected breathing frequency and the individual resonant breathing frequency; Transcranial stimulation module: When the real-time acquired respiratory frequency is the same as the individual resonant respiratory frequency, stimulation is performed according to the preset stimulation parameters.

2. The neuromodulatory device integrating transcranial stimulation and resonant breathing according to claim 1, characterized in that: A is 0-30°.

3. The neuromodulatory device integrating transcranial stimulation and resonant breathing according to claim 1, characterized in that: The interaction module and the breathing training module both include a voice prompt unit and / or a display unit.

4. The neuromodulatory device integrating transcranial stimulation and resonant breathing according to claim 1, characterized in that: The interactive module is also used to set preset stimulation parameters.

5. The neuromodulatory device integrating transcranial stimulation and resonant breathing according to claim 4, characterized in that: The preset stimulation parameters include stimulation mode, stimulation intensity, stimulation position and / or stimulation frequency.

6. The neuromodulatory device integrating transcranial stimulation and resonant breathing according to claim 1, characterized in that: The ECG monitoring module uses three-lead ECG electrodes to collect ECG signals, and the respiratory monitoring module uses a chest-strap respiratory belt to collect respiratory signals.

7. The neuromodulatory device integrating transcranial stimulation and resonant breathing according to any one of claims 1 to 6, characterized in that: The stimulation of the transcranial stimulation module is electrical stimulation.

8. A method of neural regulation combining transcranial stimulation and resonant breathing, characterized in that: include: Step 1: Before stimulation, collect the subject's ECG and respiratory signals; Step 2: construct a respiratory signal curve based on the collected respiratory signal and perform peak detection, calculate the time interval between adjacent peaks to obtain the respiratory frequency; perform ECG R peak detection on the collected ECG signal, calculate the time interval between adjacent R peaks, and form a heartbeat sequence from the time interval to obtain a heartbeat signal curve; perform phase synchronization calculation based on the respiratory signal curve and the heartbeat signal curve to obtain the phase difference between the respiratory signal curve and the heartbeat signal curve; Step 3, guiding the subject to adjust breathing, and determining the breathing frequency when the phase difference between the breathing signal curve and the heartbeat signal curve is equal to A as the individual resonant breathing frequency; Step 4: Collect the subject's ECG signal and respiratory signal in real time; Step 5, guiding the subject to adjust the breathing frequency according to the difference between the real-time breathing frequency and the individual resonant breathing frequency; Step 6: When the real-time respiratory frequency is the same as the individual resonant respiratory frequency, stimulation is performed according to the preset stimulation parameters.

9. The neural regulation method integrating transcranial stimulation and resonance breathing according to claim 8, characterized in that: In step 3 and step 5, the subject is guided to adjust the breathing rate through voice and / or display.

10. The neural regulation method integrating transcranial stimulation and resonance breathing according to claim 8, characterized in that: In step 6, the preset stimulation parameters are determined according to the basic characteristics of the subject.

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