Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

Capital Medical University

Status: Completed

Conditions: Meniere Disease

Treatments: Other: Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine

Study type: Interventional

Funder types: Other

Identifiers

NCT05328895

taVNS-MD-2022

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 20 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >=18 and Age <=70.
2. Clinical diagnosis of meniere disease.

Exclusion criteria

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups, including a placebo group

taVNS group

Experimental group

Description:

taVNS was applied using a Huatuo stimulator (SDZIIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily. The two electrodes were placed on the cymba conchae and concha around the left ear. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Treatment:

Other: Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine

Control Group

Placebo Comparator group

Description:

tnVNS was applied using a Huatuo stimulator (SDZIIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily. The two electrodes were placed on the antihelix around the left ear. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Treatment:

Other: Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine