Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04686695

Enrollment

Registered

2020-12-29

Start date

2018-03-01

Completion date

2020-05-31

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere Disease

Keywords

Transcutaneous auricular vagus nerve stimulation

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.

Interventions

DEVICEtaVNS

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 66 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026