RecruitingPhase 1Phase 2NCT06001593

Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation

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

Sponsor

Seoul National University Hospital

Enrollment

120 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

Meniere's Disease

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

Min Age: 19 YearsMax Age: 80 Years

Inclusion Criteria6

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

Exclusion Criteria8

Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media, profound hearing loss, hyperacusis, etc.).
Patients' conditions that may affect EEG measurements, such as a stroke, brain hemorrhage, or brain tumor.
Patients with kidney disease
Patients Have or have had a serious medical condition, such as cancer (including leukemia, blood cancers, epilepsy, and neuropsychiatric conditions).
Patients with an artificial implant in the body (cochlear implant, hip joint, pacemaker, etc.)
Women of childbearing potential, pregnant women, or nursing mothers
Patients who can have Injuries or dermatologic abnormalities at the site of application of the equipment.
Patients with coronary artery disease, uncontrolled high blood pressure, or other serious medical conditions (including kidney disease).

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