Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

NCT05328895 | Completed

• 1 other identifier: taVNS-MD-2022
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Meniere Disease; taVNS; RCT

Outcome Measures

Primary Outcomes (4)

• Tinnitus Handicap Inventory (THI)

  The THI is a 25-items, self-reported questionnaire regarding tinnitus handicap in daily life. The questionnaire comprises a 12-item functional subscale, an 8-item emotional subscale, and a 5-item catastrophic subscale. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of tinnitus symptoms. measure the subjective tinnitus symptoms.

  Change from Baseline scores of THI at 12-weeks post-therapy.

• Dizziness Handicap Inventory (DHI)

  The DHI is 25-items self-reported questionnaire that used to evaluate the functional, emotional, and physical impact of dizziness on patients' daily life. Among the overall 25 items of questions, 9 items are emotional related, 9 items are functional related, and 7 items are physical related questions. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of dizziness symptoms.

  Change from Baseline scores of DHI at 12-weeks post-therapy.

• Pure tone thresholds.

  The pure tone thresholds was performed in a sound-attenuated, double-walled booth with circumaural headphones (Sennheiser HD 280 for frequencies from 250 to 8000 Hz and Sennheiser HD 200 for frequencies from 8000 to 14000 Hz; Sennheiser, Old Lyme, USA) on a certified and calibrated audiometric system (Interacoustics, Middelfart, Denmark). Thresholds were measured using a probe-detection paradigm with pure tones presented for 250 ms at frequencies of 250, 500, 1000, 2000, 4000, 8000 Hz for each ear. To determine the LDL, the volume was set to 75 dB at 1000 Hz and then continuously raised in 5 dB steps (every 5 s) until the subject gave the signal that this volume was uncomfortable. When the volume exceeded 110 dB the test was stopped to prevent any hearing damage. The severity of hearing impairment was calculated as mild (20-40 dB), moderate (41-70 dB), severe (71-95 dB) and profound (\>95 dB). Normal hearing was defined as pure-tone thresholds less than 20 dB.

  Change from Baseline level of Pure tone thresholds at 12-weeks post-therapy.

• Visual analogue scale (VAS)

  The VAS scale of aural fullness consists of a 100 mm straight line with defined endpoints ("no aural fullness" and "worst aural fullness imaginable") on which the patients were asked to mark their experienced aural fullness (results in mm) at the actual time ("VAS now"). The higher VAS score (Range: 0-100) is correlated with a severe aural fullness.

  Change from Baseline scores of VAS of aural fullness at 12-weeks post-therapy.

Secondary Outcomes (3)

• The Short Form Health Survey (SF36)

  Change from Baseline scores of SF-36 at 12-weeks post-therapy.

• Video head impulse test (vHIT)

  Change from Baseline number of pathological saccades and values of vHIT at 12-weeks post-therapy.

• The caloric test

  Change from Baseline number of abnormal Unilateral Weakness (UW) at 12-weeks post-therapy.

Study Arms (2)

taVNS group

EXPERIMENTAL

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.

Other: Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine

Control Group

PLACEBO COMPARATOR

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.

Other: Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine OTHER

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.

Control Group; taVNS group

Eligibility Criteria

• Age: 20 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>=18 and Age \<=70.
• Clinical diagnosis of meniere disease.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing TongRen Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

• Wu D, Liu B, Wu Y, Wang Y, Sun J, Yang J, Duan J, Liu G, Cao K, Zhang Y, Rong P. Meniere Disease treated with transcutaneous auricular vagus nerve stimulation combined with betahistine Mesylate: A randomized controlled trial. Brain Stimul. 2023 Nov-Dec;16(6):1576-1584. doi: 10.1016/j.brs.2023.10.003. Epub 2023 Oct 13.

  PMID: 37838094 DERIVED

MeSH Terms

Conditions

Meniere Disease

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 14, 2022
• Study Start: October 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-03

Locations

CN (1)