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
Overview
- Phase
- Phase 1
- Intervention
- YPS-201b
- Conditions
- Meniere's Disease
- Sponsor
- Seoul National University Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
electircal stimulation + betahistine
Intervention: YPS-201b
electircal stimulation + betahistine
Intervention: betahistine
sham electircal stimulation + betahistine
Intervention: betahistine
sham electircal stimulation + betahistine
Intervention: YPS-201b
betahistine
control group
Intervention: betahistine
Outcomes
Primary Outcomes
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Time Frame: 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)
Time Frame: 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.
electroencephalography(Efficacy)
Time Frame: 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.
Valuation of hearing threshold with pure tone audiometry(Efficacy)
Time Frame: 0,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.