NCT05328895

Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: Randomized Trial Controlled

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 61 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 88 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.

Conditions

• Meniere Disease

Interventions

Type	Name	Description
OTHER	Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine	Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the left ear was selected and stimulated with electronic acupuncture apparatus (Hwato, SDZ-IIB), with continuous wave, 25 Hz in frequency, 4 to 8 mA in intensity depending on patient's tolerance. The first 3 treatments were conducted in hospital, during which, the patients were trained to use the apparatus under the instruction of research staff. Afterwards, the rest treatments were exerted at home, twice a day, after every breakfast and dinner respectively, 30 min each time. The treatment was given from Monday to Friday a week, totally for 12 weeks. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-01-01
• Completion: 2022-05-01
• First posted: 2022-04-14
• Last updated: 2022-10-31

Locations

1 site across 1 country: China