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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meniere's Disease

Intervention / Treatment
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* Device: YPS-201b
* Drug: betahistine
* Device: YPS-201b


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electircal stimulation + betahistine<br> | Device: YPS-201b<br>* electrical stimulation device.<br>Drug: betahistine<br>* Relieve symptoms of balance disorders or dizziness<br>|
| Sham Comparator: sham electircal stimulation + betahistine<br> | Drug: betahistine<br>* Relieve symptoms of balance disorders or dizziness<br>Device: YPS-201b<br>* sham electrical stimulation device.<br>|
| Other: betahistine<br>control group | Drug: betahistine<br>* Relieve symptoms of balance disorders or dizziness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy) | Verifying therapeutic effect of electrical stimulation | 0,2,4,8,12 weeks during electrical stimulation | 
| Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy) | 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. | 0,4,8,12 weeks during electrical stimulation | 
| Valuation of hearing threshold with pure tone audiometry(Efficacy) | Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing. | 0,4,8,12 weeks during electrical stimulation | 
| electroencephalography(Efficacy) | Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation. | 0,1,4,8,12 weeks during electrical stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, Electroceutical, Meniere's disease