Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease
NCT ID: NCT06544590
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
77 participants
OBSERVATIONAL
2019-01-01
2024-07-10
Brief Summary
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Methods: We enrolled 231 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, 3 months, 6 months, and 12 months. Video head impulse test (VHIT), the caloric test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Control group
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
taVNS group
taVNS
TaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms \[18,28\]. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. In the taVNS group received 12 weeks of treatment (30 min each time, once daily, 5 times per week).
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
sham taVNS group
taVNS
TaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms \[18,28\]. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. In the taVNS group received 12 weeks of treatment (30 min each time, once daily, 5 times per week).
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
Interventions
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taVNS
TaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms \[18,28\]. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. In the taVNS group received 12 weeks of treatment (30 min each time, once daily, 5 times per week).
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Locations
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China Beijing TongRen Hospital, Capital Medical University Beijing, China
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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taVNS-MD-2024
Identifier Type: -
Identifier Source: org_study_id
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