Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

Study Overview
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Brief Summary
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Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

Official Title
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Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study

Conditions
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Meniere Disease

Intervention / Treatment
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* Device: taVNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 and Age <=70. Clinical diagnosis of meniere disease. Exclusion Criteria: History of depression, tumors, thyroid disease, diabetes, cardiac diseases. History of Otorhinolaryngology surgery. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Auricular Vagus Nerve Stimulation<br> | Device: taVNS<br>* taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks | Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms | Day 0 and postintervention at Week 12 | 
| Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks | DHI to measure the subjective dizziness symptoms. | Day 0 and postintervention at Week 12 | 
| Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks | Pure Tone Audiometry to measure the audition. | Day 0 and postintervention at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks | SF-36 to measure quality of life | Day 0 and postintervention at Week 12 | 
| Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks | Visual scale to measure the subjective ear stuffiness symptoms | Day 0 and postintervention at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous auricular vagus nerve stimulation