Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

December 23, 2020 updated by: Beijing Tongren Hospital

Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study

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

Methods: We accrued 25 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 66 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transcutaneous Auricular Vagus Nerve Stimulation
Device: taVNS
taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms
Day 0 and postintervention at Week 12
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
DHI to measure the subjective dizziness symptoms.
Day 0 and postintervention at Week 12
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
Pure Tone Audiometry to measure the audition.
Day 0 and postintervention at Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
SF-36 to measure quality of life
Day 0 and postintervention at Week 12
Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
Visual scale to measure the subjective ear stuffiness symptoms
Day 0 and postintervention at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

May 31, 2020

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (ACTUAL)

December 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • taVNS-MD-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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