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

Seoul National University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Meniere's Disease

Treatments: Drug: betahistine; Device: YPS-201b

Study type: Interventional

Funder types: Other

Identifiers

NCT06001593

2304-098-1425

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

electircal stimulation + betahistine

Experimental group

Treatment:

Device: YPS-201b

Device: YPS-201b

Drug: betahistine

sham electircal stimulation + betahistine

Sham Comparator group

Treatment:

Device: YPS-201b

Device: YPS-201b

Drug: betahistine

betahistine

Other group

Description:

control group

Treatment:

Drug: betahistine