Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

NCT04686695 | Completed

• 1 other identifier: taVNS-MD-2020
• Study Type: interventional
• Target: 25
• 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 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.

Conditions

Meniere Disease

Keywords

Transcutaneous auricular vagus nerve stimulation

Outcome Measures

Primary Outcomes (3)

• Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks

  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

  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

  Pure Tone Audiometry to measure the audition.

  Day 0 and postintervention at Week 12

Secondary Outcomes (2)

• Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks

  Day 0 and postintervention at Week 12

• Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks

  Day 0 and postintervention at Week 12

Study Arms (1)

Transcutaneous Auricular Vagus Nerve Stimulation

EXPERIMENTAL

Device: taVNS

Interventions

taVNS DEVICE

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.

Transcutaneous Auricular Vagus Nerve Stimulation

Eligibility Criteria

• Age: 40 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Beijing, China

Location

MeSH Terms

Conditions

Meniere Disease

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: June 18, 2024

Record last verified: 2020-12

Locations

CN (1)