Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients with dizziness (Meniere's) only, who understand the nature of the study and are willing to participate voluntarily.

• The frequency of the hearing loss is between 250 kHz and 1 kHz.

• Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65 dB HL

• Patients who have received conventional pharmacotherapy for other dizziness conditions with a washout period of 2 months.

• To be eligible for subjects in the active phase of the disease, there must be at least 1 vertigo attack in the 6 months before study entry.

• If tests for renal function, electrolytes, etc. are performed and no problems are found

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Myung-Whan Suh
drmung@naver.com
+821039490330
Backup
Dong-min Kang
dongmin_4@naver.com
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Experimental: electircal stimulation + betahistine
Sham_comparator: sham electircal stimulation + betahistine
Other: betahistine
control group
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov