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

Phase 1

Recruiting

• Conditions: Meniere's Disease
• Interventions: Device: YPS-201b; Drug: betahistine

• Registration Number: NCT06001593
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-21
• Study Start: 2023-09-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-11
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electircal stimulation + betahistine	YPS-201b	-
sham electircal stimulation + betahistine	YPS-201b	-
electircal stimulation + betahistine	betahistine	-
sham electircal stimulation + betahistine	betahistine	-
betahistine	betahistine	control group

Primary Outcome Measures

Name	Time	Method
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)	0,2,4,8,12 weeks during electrical stimulation	Verifying therapeutic effect of electrical stimulation
Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)	0,4,8,12 weeks during electrical stimulation	Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.
Valuation of hearing threshold with pure tone audiometry(Efficacy)	0,4,8,12 weeks during electrical stimulation	Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
electroencephalography(Efficacy)	0,1,4,8,12 weeks during electrical stimulation	Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of