Noninvasive nerve regulation method and system for treating tinnitus through multi-sensory homeostasis stimulation

Abstract

The invention discloses a noninvasive nerve regulation and control method and system for treating tinnitus through multi-sensory steady-state stimulation. The regulation and control method comprises the steps that tinnitus characteristics of a patient are evaluated, relevant tinnitus characteristic parameters of the patient are obtained, and a tinnitus characteristic parameter file of the patient is formed; an individualized steady-state rhythm stimulation scheme is formulated; individualized composite gamma wave band rhythm signals are generated, multiple steady-state rhythm stimulation of light, sound and electricity is applied at the same time, tinnitus responsible brain area nerve electrical activity is noninvasively adjusted through multi-mode sense organs of vision, hearing and somatosensory, and abnormal brain electrical activity is regulated and controlled in combination with real-time brain electrical feedback so as to treat tinnitus. According to the regulation and control method, the corresponding stimulation scheme is formulated based on the tinnitus characteristics of the patient, the individualized composite rhythm signals are adopted, multi-mode non-invasive stimulation such as light and sound is applied at the same time, the tinnitus responsible brain area nerve electrical activity is regulated, and the treatment effect is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of tinnitus treatment, and in particular to a non-invasive neural regulation method and system for treating tinnitus by combining multi-sensory steady-state stimulation of light and sound. Background Art

[0002] Tinnitus is a common clinical disease, which refers to the hearing of sounds in one or both ears that do not exist in the outside world. Tinnitus often sounds like "buzzing", "chirping" or cicadas. More than 10% of the world's population suffers from tinnitus. Some patients with severe tinnitus may also suffer from complications such as anxiety, depression, and sleep disorders, which seriously damage their health. Because the cause of tinnitus is still unclear, there is a lack of specific methods for effective treatment of tinnitus in clinical practice. Tinnitus sound therapy is currently the most widely used tinnitus therapy in clinical practice, but this method has an unavoidable key defect: most tinnitus patients have varying degrees of hearing loss, or even severe deafness, so the single sensory auditory stimulation of sound therapy is difficult to achieve effective regulation effects for tinnitus patients with hearing loss.

[0003] In recent years, studies have found that tinnitus is related to abnormal neural electrical activity in the brain, so regulating abnormal neural electrical activity in the brain can fundamentally eliminate tinnitus symptoms. Domestic and foreign scholars have successively developed treatment methods such as repetitive transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve electrical stimulation, and surface skin electrical stimulation, trying to use these stimulation methods to regulate abnormal brain electrical activity that causes tinnitus. However, the above treatment methods have the following disadvantages: 1. They may cause varying degrees of trauma to the human body; 2. The treatment effect is uncertain; 3. Special and expensive equipment is required; 4. It may cause complications or side effects in other systems of the body. Therefore, these treatment methods have not been widely used in clinical practice, and there is an urgent need for safer, non-invasive, individualized and easy-to-implement tinnitus treatment methods.

[0004] In the prior art, a tinnitus VR rehabilitation system is disclosed, which helps patients relax their bodies, soothe their nerves, reduce their anxiety and depression through virtual VR experience + music, and achieves the effect of eliminating the psychological tinnitus problem of patients through psychotherapy. Although patients can get slight relief in the above technology, it takes a long time for intervention to show the therapeutic effect when using this method. Therefore, during the treatment process, the patient's compliance is poor, which will greatly affect the efficacy. Summary of the invention

[0005] In order to overcome the deficiencies of the prior art, one of the objectives of the present invention is to provide a non-invasive neural regulation method for treating tinnitus using multi-sensory steady-state stimulation to solve the above-mentioned traditional problems.

[0006] One of the purposes of the present invention is to provide a non-invasive neural regulation system for treating tinnitus using multi-sensory steady-state stimulation using the non-invasive neural regulation method.

[0007] One of the purposes of the present invention is achieved by the following technical solution:

[0008] A non-invasive neural regulation method for treating tinnitus using multi-sensory steady-state stimulation, comprising the following steps:

[0009] S1: Evaluate the patient's tinnitus characteristics, obtain the patient's tinnitus-related characteristic parameters, and form the patient's tinnitus characteristic parameter file;

[0010] S2: Develop an individualized steady-state rhythm stimulation program based on the patient's tinnitus characteristic parameter file;

[0011] S3: Wear a head-mounted multi-sensory steady-state stimulation neural regulation device to generate an individualized composite γ-band rhythmic signal, and simultaneously apply a variety of steady-state rhythmic stimulations of light, sound, and electricity. Through the multi-modal senses of vision, hearing, and body sensation, the neural electrical activity of the tinnitus-responsible brain area is non-invasively regulated, and combined with real-time EEG feedback, abnormal EEG activity is regulated to treat tinnitus.

[0012] Preferably, in step S1, the tinnitus-related characteristic parameters include tinnitus sound frequency, loudness, rhythm and side.

[0013] Preferably, in step S1, the step of evaluating comprises the following steps:

[0014] a. Auditory matching test; b. Obtaining loudness discomfort threshold; c. Rhythm and laterality assessment.

[0015] Preferably, the auditory matching test comprises the following specific steps:

[0016] 1) Frequency matching: Use a pure tone audiometer to gradually adjust the pitch until the patient confirms that the pitch is consistent with the tinnitus;

[0017] 2) Loudness matching: After finding the matching frequency, continue to adjust the volume until the patient perceives the loudness of the pure tone to be consistent with the loudness of the tinnitus.

[0018] Preferably, in step S2, the specific steps of formulating an individualized steady-state rhythm stimulation program are:

[0019] By analyzing the patient's tinnitus characteristic parameters, the corresponding audio file is selected, and the audio file is modulated with a sine wave in the γ-band frequency range to generate an individualized steady-state rhythmic stimulation sound signal. Then, based on the individualized steady-state rhythmic stimulation sound signal, corresponding light and electrical steady-state rhythmic stimulation signals are prepared to form an individualized steady-state rhythmic stimulation plan.

[0020] Preferably, in step S3, the head-mounted multi-sensory steady-state stimulation neural regulation device includes light stimulation glasses and acoustic and electrical stimulation headphones electrically connected to the light stimulation glasses; the light stimulation glasses include a main frame, a control circuit installed on the main frame, an LED light strip, a rechargeable battery and a shading lens, the main frame and the shading lens form a light stimulation cavity, the LED light strip is arranged in the light stimulation cavity, the main frame is provided with a first control button group and a second control button group, the first control button group is used to adjust the light intensity of the LED light strip and the current of the acoustic and electrical stimulation headphones, the second control button group is used to adjust the volume of the acoustic and electrical stimulation headphones, and the control circuit is electrically connected to the LED light strip, the rechargeable battery, the first control button group, the second control button group, and the acoustic and electrical stimulation headphones, respectively.

[0021] Preferably, in step S3, light stimulation parameters: frequency 20-60 Hz; sound stimulation parameters: modulation frequency 20-60 Hz, the carrier masking frequency is set to one-third octave range of the tinnitus frequency, intensity: set according to the tinnitus loudness threshold to ensure that the sound stimulation intensity is not lower than the patient's tinnitus loudness threshold; electrical stimulation parameters: set according to the patient's tolerance, the initial intensity should be lower than the patient's discomfort threshold, pulse width: 100-300 microseconds.

[0022] Preferably, the non-invasive neural regulation method further comprises:

[0023] S4: Collect and analyze EEG signals, and adjust treatment parameters based on changes in subjective tinnitus symptoms to achieve the goal of precise treatment.

[0024] The second object of the present invention is achieved by adopting the following technical solution:

[0025] A non-invasive neuromodulation system for treating tinnitus using multi-sensory steady-state stimulation, comprising:

[0026] S1: Evaluation module, used to evaluate the patient's tinnitus characteristics, obtain the patient's tinnitus-related characteristic parameters, and form the patient's tinnitus characteristic parameter file;

[0027] S2: Stimulation program formulation module, used to formulate individualized steady-state rhythm stimulation programs based on the patient's tinnitus characteristic parameter file;

[0028] S3: Implementation module, used to wear a head-mounted multi-sensory steady-state stimulation neural regulation device to generate an individualized composite γ-band rhythmic signal, and simultaneously apply a variety of steady-state rhythmic stimulations of light, sound, and electricity. It non-invasively regulates the neural electrical activity of the tinnitus-responsible brain area through the multi-modal senses of vision, hearing, and body sensation, and combines real-time EEG feedback to implement regulation of abnormal EEG activity to treat tinnitus.

[0029] Preferably, the non-invasive neural regulation system further comprises:

[0030] S4: Acquisition and analysis module, used to collect and analyze EEG signals, and to adjust treatment parameters based on changes in subjective symptoms of tinnitus to achieve the goal of precise treatment.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] 1. The control method of the present invention formulates a corresponding stimulation plan based on the patient's tinnitus characteristics, adopts an individualized complex rhythmic signal, and simultaneously applies multimodal non-invasive stimulation such as light and sound to regulate the neural electrical activity of the brain area responsible for tinnitus to achieve the treatment effect. In this control method, the patient can understand the content of the treatment plan, and during the treatment process, combined with real-time EEG feedback, the effect of regulating abnormal EEG activity to treat tinnitus can be achieved, thereby greatly improving the efficacy of the treatment.

[0033] 2. The control method of the present invention collects and analyzes the responsible EEG signals, combines the changes in the subjective symptoms of tinnitus, and adjusts the treatment parameters to achieve the goal of precise treatment.

[0034] 3. Traditional technologies only target tinnitus patients with specific hearing conditions, while the control method of the present invention involves tinnitus patients with and without hearing loss, and has a wider treatment scope. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a schematic flow chart of the non-invasive neural regulation method for treating tinnitus by using multi-sensory steady-state stimulation of the present invention;

[0036] Figure 2 It is a schematic diagram of the structure of the light stimulation glasses of the present invention;

[0037] Figure 3 for Figure 2 Left view of the light stimulation glasses shown;

[0038] Figure 4 for Figure 2 Right view of the light stimulation glasses shown;

[0039] Figure 5 for Figure 2 A bottom view of the light stimulation glasses shown;

[0040] Figure 6 for Figure 2 A cross-sectional view of the light stimulation glasses shown;

[0041] Figure 7 for Figure 6 An enlarged view of point A is shown;

[0042] Figure 8 for Figure 2A first-person perspective internal structure diagram of the light stimulation glasses shown;

[0043] Fig. 9 for Figure 2 The second perspective internal structure diagram of the light stimulation glasses shown;

[0044] Fig.10 It is a structural schematic diagram of the acoustic and electrical stimulation earphone of the present invention;

[0045] Fig.11 for Fig.10 Exploded view of the acoustic-electric stimulation headset shown.

[0046] In the figure: 10, light stimulation glasses; 11, main frame; 110, first control button group; 111, second control button group; 112, nose pads; 113, auxiliary fixing belt connection cavity; 114, headphone jack; 115, file import interface; 116, charging interface; 12, control circuit; 13, LED light strip; 14, rechargeable battery; 15, shading lens; 16, color adjustment lens; 20, sound and electric stimulation headphones; 21, headphone connecting line; 22, headphone shell; 23, conductive silicone; 24, first electrode; 25, speaker; 26, conductive sheet; 27, power conversion module; 28, headphone chip module; 29, second electrode; 30, third electrode. DETAILED DESCRIPTION

[0047] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0048] In the description of the present invention, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0049] In the description of the present invention, it is to be understood that when an element is considered to be "connected" to another element, it may be directly connected to the other element or there may be intermediate elements at the same time. On the contrary, when an element is said to be "directly" connected to another element, there are no intermediate elements.

[0050] Example 1

[0051] like Figure 1 As shown, a non-invasive neural regulation method for treating tinnitus using multi-sensory steady-state stimulation comprises the following steps:

[0052] S1: Evaluate the patient's tinnitus characteristics, obtain the patient's tinnitus-related characteristic parameters, and form the patient's tinnitus characteristic parameter file;

[0053] In this step, the patient's tinnitus characteristics are carefully assessed to gain a preliminary understanding of the patient's tinnitus condition, and then further treatment plans are made based on the patient's tinnitus condition.

[0054] In one embodiment, the tinnitus-related characteristic parameters include characteristic parameters such as tinnitus sound frequency, loudness, rhythm, and side (location).

[0055] The evaluation process includes the following steps:

[0056] a.Audiometric Matching Tests: Determine the frequency and loudness of tinnitus through audiometric matching tests;

[0057] b. Obtain the Loudness Discomfort Threshold. In this step, one way to measure the loudness of the tinnitus is through the Loudness Discomfort Threshold test. The technician gradually increases the volume of pure tones or noises until the patient feels discomfort. This threshold can help estimate the loudness of the tinnitus.

[0058] c. Rhythm and laterality assessment. In this step, rhythm assessment: determine the rhythm of tinnitus (such as persistence, pulse, etc.) through communication with the patient. The patient can be asked to describe the rhythm of the tinnitus or imitate the sound of the tinnitus. Laterality assessment: ask the patient whether the tinnitus occurs in the left ear, right ear, or both ears, and determine the location of the tinnitus through the patient's description.

[0059] In one embodiment, the auditory matching test specifically comprises the following steps:

[0060] 1) Frequency matching: Use a pure tone audiometer to gradually adjust the pitch until the patient confirms that the pitch is consistent with the tinnitus.

[0061] In this step, the patient works with a technician to find a pure tone frequency that matches the frequency of their tinnitus with the help of a hearing test device such as a pure tone audiometer. The pure tone audiometer is usually used to gradually adjust the pitch until the patient confirms that the tone matches the pitch of the tinnitus.

[0062] 2) Loudness matching: After finding the matching frequency, continue to adjust the volume until the patient perceives the loudness of the pure tone to be consistent with the loudness of the tinnitus.

[0063] S2: Develop an individualized steady-state rhythm stimulation program based on the patient's tinnitus characteristic parameter file;

[0064] In this step, by analyzing the patient's tinnitus characteristic parameters, the corresponding audio file is selected, and the audio file is modulated with a sine wave in the γ band frequency range (20-60Hz) to generate an individualized steady-state rhythmic stimulation sound signal, i.e., a sound stimulation plan. Then, based on the individualized steady-state rhythmic stimulation sound signal, corresponding light, electricity and other steady-state rhythmic stimulation signals are prepared to form an individualized steady-state rhythmic stimulation plan.

[0065] S3: Wear a head-mounted multi-sensory steady-state stimulation neural regulation device to generate an individualized composite γ-band rhythmic signal, and simultaneously apply a variety of steady-state rhythmic stimulations such as light, sound, and electricity. Through the multi-modal senses of vision, hearing, and body sensation, the neural electrical activity of the tinnitus-responsible brain area is non-invasively regulated, and combined with real-time EEG feedback, abnormal EEG activity is regulated to treat tinnitus, so as to achieve the effect of regulating abnormal EEG activity to treat tinnitus.

[0066] S4: Collect and analyze EEG signals, and adjust treatment parameters based on changes in subjective tinnitus symptoms to achieve the goal of precise treatment.

[0067] In this step, the specific steps are as follows:

[0068] Monitoring and recording: During treatment, the patient's EEG signals are collected and analyzed as a basis for monitoring the efficacy and providing feedback to adjust treatment parameters.

[0069] Periodic assessment: Tinnitus assessment is performed every 4 weeks, including auditory matching test, questionnaire survey and subjective perception record. The treatment plan is adjusted according to the results. If necessary, the stimulation intensity and frequency can be increased or decreased.

[0070] In one embodiment, if Figure 2-Figure 11As shown, the head-mounted multi-sensory steady-state stimulation nerve regulation device includes light stimulation glasses 10 and acoustic and electrical stimulation headphones 20 electrically connected to the light stimulation glasses 10. The light stimulation glasses 10 are used to be worn on the patient's eyes to provide light stimulation to the patient and provide power and control of each steady-state rhythm for the acoustic and electrical stimulation headphones 20. The light stimulation glasses 10 include a main frame 11, a control circuit 12 installed on the main frame 11, an LED light strip 13, a rechargeable battery 14 and a shading lens 15. The main frame 11 and the shading lens 15 form a light stimulation cavity. The LED light strip 13 is arranged in the light stimulation cavity. In the stimulation cavity, the main frame 11 is provided with a first control button group 110 and a second control button group 111. The first control button group 110 is used to adjust the light intensity of the LED light strip 13 and the current of the acoustic and electrical stimulation earphones 20. The second control button group 111 is used to adjust the volume of the acoustic and electrical stimulation earphones 20. The control circuit 12 is electrically connected to the LED light strip 13, the rechargeable battery 14, the first control button group 110, the second control button group 111, and the acoustic and electrical stimulation earphones 20 respectively. The acoustic and electrical stimulation earphones 20 are used to be worn on the patient's ears to provide acoustic and electrical stimulation to the patient.

[0071] The above-mentioned device provides patients with a variety of steady-state rhythmic stimulations such as light, sound, and electricity through the cooperation of light stimulation glasses 10 and sound and electrical stimulation headphones 20, and non-invasively regulates the neural electrical activity of the brain area responsible for tinnitus through multi-modal senses such as vision, hearing, and body sensation, and adjusts the light intensity, sound volume, and electricity intensity based on real-time conditions, so as to achieve the effect of treating tinnitus by regulating abnormal brain electrical activity, thereby achieving a safer, non-invasive, individualized and easy-to-implement tinnitus treatment effect.

[0072] In this embodiment, if Figure 2 and Figure 5 As shown, the main frame 11 is provided with a nose pad 112 and an auxiliary fixing belt connection cavity 113. The nose pad 112 is generally arc-shaped, preferably V-shaped, so as to facilitate the wearing comfort and support of the light stimulation glasses 10. The auxiliary fixing belt connection cavity 113 is used to assist the wearing of the light stimulation glasses 10 through a fixing belt (not shown) to assist the wearing of the light stimulation glasses 10 and make it more firmly worn. In one embodiment, as Figure 6 and Figure 7 As shown, at least one color-adjusting lens 16 is also provided on the main frame 11. The color-adjusting lens 16 is installed between the shading lens 15 and the LED light strip 13. The color of the color-adjusting lens 16 is green, gray, blue, gray-green and other colors. The required color-adjusting lens 16 can be added as needed to form more light stimulation scenes in the light stimulation cavity under the action of the LED light strip 13.

[0073] For example Figure 2-Figure 4 and Figure 8-Figure 9The control circuit 12 includes a main control chip circuit, a sound effect circuit and a storage chip circuit. The first control button group 110 and the main control chip circuit are arranged on the same side of the main frame 11, and the second control button group 111 and the sound effect circuit and the storage chip circuit are arranged on the other side of the main frame 11. The main control chip circuit is used to control the light intensity of the light stimulation glasses 10 and the electric stimulation current of the external acoustic and electrical stimulation headphones 20. The sound effect circuit is used to provide audio signals for the acoustic and electrical stimulation headphones 20 and control the volume. The storage chip circuit is used to integrate light stimulation parameter information, acoustic stimulation audio and electric stimulation parameter information, and coordinate with the main control chip to complete the adjustment of the stimulation parameters. Among them, the LED light strip 13 provides light stimulation of a specific frequency according to the control of the main control chip circuit. Rechargeable batteries are installed on both sides of the main frame 11 to provide power for each control circuit 12, as well as to provide power for the LED light strip 13 and the sound and electric stimulation headphones 20. Since the rechargeable battery has a low voltage such as 3.6V-4.2V, it can greatly reduce the stimulation trauma to the human body. At the same time, it can also provide sufficient stimulation for tinnitus to regulate the abnormal brain electrical activity that causes tinnitus.

[0074] In this embodiment, if Figure 5 As shown, the main frame 11 is provided with an earphone interface 114, a file import interface 115 and a charging interface 116. The earphone interface 114 is used to be electrically connected to the audio circuit, the file import interface 115 is used to be electrically connected to the storage chip circuit, and the charging interface 116 is used to be electrically connected to the rechargeable battery 14. Figure 3 As shown, the first control button group 110 includes a power switch, a first light intensity adjustment button and a second light intensity adjustment button. The power switch is used to control the power switch of the device. The first light intensity adjustment button is used to simultaneously reduce the light intensity of the LED light strip 13 and the stimulation current of the acoustic and electrical stimulation earphone 20. The second light intensity adjustment button is used to simultaneously increase the light intensity of the LED light strip 13 and the stimulation current of the acoustic and electrical stimulation earphone 20. Figure 3 As shown, the second control button group 111 includes a music switch button, a first volume adjustment button and a second volume adjustment button. The music switch button is used to switch the songs of the acoustic and electrical stimulation headphones 20, the first volume adjustment button is used to reduce the volume of the acoustic and electrical stimulation headphones 20, and the second volume adjustment button is used to increase the volume of the acoustic and electrical stimulation headphones 20.

[0075] In one embodiment, if Fig.10 and Fig.11As shown, the acoustic-electric stimulation earphone 20 includes an earphone connecting line 21, an earphone shell 22 connected to the earphone connecting line 21, a conductive silicone 23 installed on the earphone shell 22, a first electrode 24, a speaker 25, a conductive sheet 26, a power conversion module 27 and an earphone chip module 28. The earphone connecting line 21 is used to be electrically connected to the light stimulation glasses 10 to facilitate the transmission of audio signals and the current of the stimulation power supply. The conductive silicone 23 is sleeved on the first electrode 24. The earphone chip module 28 is electrically connected to the power conversion module 27, the first electrode 24, the speaker 25, and the conductive sheet 26, respectively, for transducing the music and electrical stimulation provided by the control circuit 12 of the light stimulation glasses 10.

[0076] Among them, the conductive silicone 23 is made of elastically shaped conductive material, which is used to increase the area of ​​electrical stimulation and improve the efficacy of electrical stimulation. The first electrode 24 is used to provide electrical stimulation to the external auditory canal. The conductive sheet 26 cooperates with the power conversion module 27 to be electrically connected to the first electrode 24 to ensure the stability of the electrical stimulation power supply. The speaker 25 is electrically connected to the power conversion module 27 for playing music from the headphone chip module 28. The power conversion module 27 is used to convert electrical stimulation from the headphone chip module 28 and output music.

[0077] In this embodiment, a concha cavity mounting structure and a helix crus mounting structure are provided on the earphone housing 22, a second electrode 29 is provided on the concha cavity mounting structure, and a third electrode 30 is provided on the helix crus mounting structure. The second electrode 29 and the third electrode 30 are both electrically connected to the power conversion module 27 to cooperate with the function of the first electrode 24, and are used to provide electrical stimulation to the concha cavity and the helix crus respectively, so as to enhance the electrical stimulation effect of the acoustic-electrical stimulation earphone 20 on the patient's ear.

[0078] The concha cavity installation structure is a generally shrinking structure from front to back, and the helix foot installation structure is a generally circular ring structure. Optionally, the maximum diameter of the concha cavity installation structure is 1.2-1.5 times the minimum diameter.

[0079] The charging interface 116 can both charge current into the battery and supply current to the earphone. In other embodiments, the earphone connection cable 21 is divided into an audio connection cable and a power connection cable. The audio connection cable is used to connect to the earphone interface 114 of the light stimulation glasses 10, and the power connection cable is used to connect to the charging interface 116 of the light stimulation glasses 10.

[0080] Its working principle is: through the file import interface 115 of the main frame 11, a tinnitus stimulation program, such as light, sound, electricity and other stimulation programs, is imported into the control circuit 12, and the light stimulation glasses 10 and the sound and electric stimulation headphones 20 are worn, the light stimulation glasses 10 and the sound and electric stimulation headphones 20 are connected, and then turned on, and a variety of steady-state rhythmic stimulations such as light, sound, and electricity are applied to the patient. When the patient needs to adjust the volume or switch songs, the second control button group 111 can be used to perform corresponding operations. When the patient needs to adjust the light intensity of the LED light strip 13 and the current of the sound and electric stimulation headphones 20, the first control button group 110 can be used to perform corresponding operations, so that the light, sound, electricity and other stimulation programs are suitable for the needs of the patient, so as to better achieve the effect of treating tinnitus.

[0081] In one embodiment, the stimulation parameters are:

[0082] The LED light flashes at a frequency of 20-60Hz, a color temperature of 4000-5000, and adjustable brightness; the 3.5mm jack multifunctional earphone has physical sound insulation performance, and plays modulated music, which is synchronized with the stroboscopic stimulation. The stimulation sound signal modulates the soft music at 30-80Hz. The intensity of the light and sound stimulation is adjusted by the user according to his or her own comfort level, but the intensity of the sound stimulation should not be lower than the tinnitus loudness threshold. Among them, a. Light stimulation parameters: frequency: 20-60Hz, intensity: adjustable light intensity set according to safety standards, color: 4000-5000. b. Sound stimulation parameters: modulation frequency: 20-60Hz, carrier frequency: masking sound is set to one-third octave range of tinnitus frequency, intensity: set according to tinnitus loudness threshold, to ensure that the intensity of sound stimulation is not lower than the patient's tinnitus loudness threshold. Sound type: Select personalized soothing background music as the sound stimulation signal, and add narrowband noise on this basis, with the center frequency being the tinnitus frequency. c. Vagus nerve somatosensory stimulation parameters (ie, electrical stimulation): stimulation frequency: 20-60 Hz, stimulation intensity: set according to the patient's tolerance, the initial intensity should be lower than the patient's discomfort threshold, pulse width: 100-300 microseconds.

[0083] In one embodiment, the stimulation program comprises the following steps:

[0084] Calibration and inspection: Calibrate the equipment before each treatment to ensure that the parameters of light stimulation, sound stimulation and electrical stimulation meet the set values. Ensure that the light stimulation glasses, headphones and vagus nerve stimulation electrodes are worn correctly and adjusted to a comfortable position.

[0085] Combined stimulation: Light stimulation, sound stimulation and vagus nerve electrical stimulation are performed simultaneously to ensure the coordination and synchronization of the three stimulation methods.

[0086] Stimulation time: Each stimulation lasts 30 minutes, 3-5 times a week, and the treatment lasts 8-12 weeks.

[0087] Rest Intervals: Set rest intervals between each stimulation to avoid fatigue and discomfort.

[0088] Example 2

[0089] The present invention also discloses a non-invasive neural regulation system for treating tinnitus using multi-sensory steady-state stimulation, comprising:

[0090] S1: Evaluation module, used to evaluate the patient's tinnitus characteristics, obtain the patient's tinnitus-related characteristic parameters, and form the patient's tinnitus characteristic parameter file;

[0091] S2: Stimulation program formulation module, used to formulate individualized steady-state rhythm stimulation programs based on the patient's tinnitus characteristic parameter file;

[0092] S3: Implementation module, used to wear a head-mounted multi-sensory steady-state stimulation neural regulation device to generate individualized composite γ-band rhythmic signals, and simultaneously apply a variety of steady-state rhythmic stimulations of light, sound, and electricity, to non-invasively regulate the neural electrical activity of the tinnitus-responsible brain area through the multi-modal senses of vision, hearing, and body sensation, and to implement regulation of abnormal EEG activity to treat tinnitus in combination with real-time EEG feedback;

[0093] S4: Acquisition and analysis module, used to collect and analyze EEG signals, and to adjust treatment parameters based on changes in subjective symptoms of tinnitus to achieve the goal of precise treatment.

[0094] Example 3

[0095] Application examples:

[0096] Patient 1 had no obvious hearing loss but reported persistent tinnitus in the right ear, described as a low-frequency "buzzing" sound. Audiometry results were normal, but the patient's tinnitus lasted for a long time and affected his sleep and daily life.

[0097] Treatment

[0098] 1. Assessment of tinnitus characteristics

[0099] Through the auditory matching test, it was confirmed that the tinnitus frequency was about 4kHz and the loudness was 45dB. The patient had no other hearing loss in the right ear.

[0100] Questionnaire evaluation scale

[0101] ① Tinnitus Handicap Inventory (THI), a total of 25 questions (divided into three parts: functional, emotional, and catastrophic), each question has three options: "no", "occasionally", and "yes", with corresponding scores of 0, 2, and 4 points, and a total score of 0 to 100 points. Among them, 0 to 16 points are level 1 mild tinnitus, 18 to 36 points are level 2 mild tinnitus, 38 to 56 points are level 3 moderate tinnitus, 58 to 76 points are level 4 severe tinnitus, and 78 points or more are level 5 catastrophic tinnitus. In this study, the patient's THI score was used as an indicator of tinnitus severity.

[0102] ②The Tinnitus Functional Index (TFI) consists of 25 items divided into 8 subscales: intrusiveness, sense of control, cognitive interference, sleep disturbance, hearing problems, relaxation, quality of life, and emotional distress. A total score of 26 or higher indicates that tinnitus has a significant impact on a person's life. This questionnaire determines the severity of tinnitus and the negative impact that the person is experiencing.

[0103] ③The Hyperacusis Questionnaire (HQ) consists of 14 questions that can be answered with "Not true", "Sometimes true", "Often true", and "Always true". Hyperacusis is considered to be present in subjects who score 28 points or more.

[0104] ④VAS: The scale ranges from 0 to 10. The patient judges the loudness of his or her own tinnitus. The higher the score, the louder the tinnitus and the greater the impact. It is divided into 4 levels: 0: no sound, no interference; 1-3: mild sound, no impact on work and life; 4-6: moderate sound, impact on work, no impact on life; 7-10: severe sound, impact on work and life.

[0105] ⑤HADS: It consists of 14 items, of which 7 items assess depression and 7 items assess anxiety. According to the original author's standard, the scores of the anxiety and depression subscales are divided into 0-7 points for no symptoms; 8-10 points for suspected symptoms; 11-21 points for definite symptoms.

[0106] Personalized Steady-State Rhythmic Sound Stimulation

[0107] 2. Based on the obtained tinnitus frequency, a narrowband noise with a frequency of one-third octave is generated, and its center frequency is set to the tinnitus frequency to achieve a more focused noise coverage effect. On this basis, soothing background music is added to reduce the patient's anxiety and discomfort. Finally, the composite audio signal is frequency modulated in the γ band of 20-60Hz to generate special sound stimulation music.

[0108] Steady-state photoacoustic stimulation

[0109] A head-mounted steady-state stimulation device is used to provide 20-60Hz light stimulation in the gamma band through an LED light strip, and acoustic stimulation is performed synchronously. The light color temperature is controlled at 4500K and the light intensity is adjustable.

[0110] The audio signal is transmitted through sound-isolating headphones, and the intensity of the sound stimulation is set slightly higher than the loudness of the tinnitus to ensure effective neural modulation.

[0111] Non-invasive vagus nerve stimulation

[0112] Add vagus nerve electrical stimulation to enhance the neuromodulatory effect. Select a frequency of 20-60Hz to perform low-intensity electrical stimulation on the vagus nerve area (such as the concha cavity). The initial electrical stimulation intensity is set below the patient's discomfort threshold and gradually increased to the patient's maximum tolerance range in subsequent treatments. The pulse width of each electrical stimulation is set at 100-300 microseconds to ensure the safety and effectiveness of the stimulation.

[0113] Treatment options

[0114] Each treatment lasts 30 minutes and is performed 3-5 times a week for 12 weeks.

[0115] Tinnitus is evaluated periodically every 4 weeks, and the photoacoustic stimulation parameters are adjusted according to changes in tinnitus loudness and frequency to optimize the treatment effect.

[0116] Through the above treatment, after a period of time, the persistent tinnitus in the right ear of Patient 1 was significantly improved, and his sleep and daily life were no longer affected by the continuous "buzzing" sound.

[0117] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0118] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A non-invasive neural regulation method for treating tinnitus using multi-sensory steady-state stimulation, characterized in that: The steps include: S1: Evaluate the patient's tinnitus characteristics, obtain the patient's tinnitus-related characteristic parameters, and form the patient's tinnitus characteristic parameter file; S2: Develop an individualized steady-state rhythm stimulation program based on the patient's tinnitus characteristic parameter file; S3: Wear a head-mounted multi-sensory steady-state stimulation neural regulation device to generate an individualized composite γ-band rhythmic signal, and simultaneously apply a variety of steady-state rhythmic stimulations of light, sound, and electricity. Through the multi-modal senses of vision, hearing, and body sensation, the neural electrical activity of the tinnitus-responsible brain area is non-invasively regulated, and combined with real-time EEG feedback, abnormal EEG activity is regulated to treat tinnitus.

2. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 1, characterized in that: In step S1 , tinnitus-related characteristic parameters include tinnitus sound frequency, loudness, rhythm and side.

3. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 1, characterized in that: In step S1, the evaluation step includes the following steps: a. Auditory matching test; b. Obtaining loudness discomfort threshold; c. Rhythm and laterality assessment.

4. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 3, characterized in that: The auditory matching test specifically includes the following steps: 1) Frequency matching: Use a pure tone audiometer to gradually adjust the pitch until the patient confirms that the pitch is consistent with the tinnitus; 2) Loudness matching: After finding the matching frequency, continue to adjust the volume until the patient perceives the loudness of the pure tone to be consistent with the loudness of the tinnitus.

5. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 1, characterized in that: In step S2, the specific steps of formulating an individualized steady-state rhythm stimulation program are: By analyzing the patient's tinnitus characteristic parameters, the corresponding audio file is selected, and the audio file is modulated with a sine wave in the γ-band frequency range to generate an individualized steady-state rhythmic stimulation sound signal. Then, based on the individualized steady-state rhythmic stimulation sound signal, corresponding light and electrical steady-state rhythmic stimulation signals are prepared to form an individualized steady-state rhythmic stimulation plan.

6. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 1, characterized in that: In step S3, the head-mounted multi-sensory steady-state stimulation neural regulation device includes light stimulation glasses and acoustic and electrical stimulation headphones electrically connected to the light stimulation glasses; the light stimulation glasses include a main frame, a control circuit installed on the main frame, an LED light strip, a rechargeable battery and a shading lens, the main frame and the shading lens form a light stimulation cavity, the LED light strip is arranged in the light stimulation cavity, the main frame is provided with a first control button group and a second control button group, the first control button group is used to adjust the light intensity of the LED light strip and the current of the acoustic and electrical stimulation headphones, the second control button group is used to adjust the volume of the acoustic and electrical stimulation headphones, and the control circuit is electrically connected to the LED light strip, the rechargeable battery, the first control button group, the second control button group, and the acoustic and electrical stimulation headphones, respectively.

7. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 1, characterized in that: In step S3, light stimulation parameters: frequency 20-60 Hz; sound stimulation parameters: modulation frequency 20-60 Hz, carrier masking frequency is set to one-third octave range of tinnitus frequency, intensity: set according to tinnitus loudness threshold, ensure that the sound stimulation intensity is not lower than the patient's tinnitus loudness threshold; Electrical stimulation parameters: set according to the patient's tolerance, the initial intensity should be lower than the patient's discomfort threshold, pulse width: 100-300 microseconds.

8. The non-invasive neural regulation method for treating tinnitus by multi-sensory steady-state stimulation according to claim 1, characterized in that: The non-invasive neuromodulation method further comprises: S4: Collect and analyze EEG signals, and adjust treatment parameters based on changes in subjective tinnitus symptoms to achieve the goal of precise treatment.

9. A non-invasive neural control system for treating tinnitus using multi-sensory steady-state stimulation, characterized in that: include: S1: Evaluation module, used to evaluate the patient's tinnitus characteristics, obtain the patient's tinnitus-related characteristic parameters, and form the patient's tinnitus characteristic parameter file; S2: Stimulation program formulation module, used to formulate individualized steady-state rhythm stimulation programs based on the patient's tinnitus characteristic parameter file; S3: Implementation module, used to wear a head-mounted multi-sensory steady-state stimulation neural regulation device to generate an individualized composite γ-band rhythmic signal, and simultaneously apply a variety of steady-state rhythmic stimulations of light, sound, and electricity. It non-invasively regulates the neural electrical activity of the tinnitus-responsible brain area through the multi-modal senses of vision, hearing, and body sensation, and combines real-time EEG feedback to implement regulation of abnormal EEG activity to treat tinnitus.

10. The non-invasive neural regulation system for treating tinnitus by multi-sensory steady-state stimulation according to claim 9, characterized in that: The non-invasive neural regulation system further comprises: S4: Acquisition and analysis module, used to collect and analyze EEG signals, and to adjust treatment parameters based on changes in subjective tinnitus symptoms to achieve the goal of precise treatment.

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