NCT06544590

Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: A Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. 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.

Conditions

• Meniere Disease

Interventions

Type	Name	Description
DEVICE	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).
DRUG	Betahistine Mesylate tablet	Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Timeline

• Start date: 2019-01-01
• Primary completion: 2024-07-01
• Completion: 2024-07-10
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China