Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

Meniere Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686695
• Other study ID #: taVNS-MD-2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: December 2020
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniere Disease

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

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