Actively Recruiting
Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled Trial
Led by Seoul National University Hospital · Updated on 2024-12-05
120
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of non-invasive electrical stimulation applied to the mastoid area behind the ear to manage auditory symptoms and dizziness in patients with Meniere's disease. This is a double-blind, randomized, sham-controlled trial initiated by investigators to explore this new device-based approach alongside medication. The study is sponsored by Seoul National University Hospital and focuses on people aged 19 to 80 years who have active symptoms of the disease. Participants are assigned to one of three groups: electrical stimulation device plus betahistine medication, a sham (placebo) electrical stimulation device plus betahistine, or betahistine alone. The electrical stimulation is delivered using the YPS-201b device, and the study includes a sham device for comparison. Betahistine is given to help relieve dizziness symptoms. The treatment period includes multiple assessments over 12 weeks during electrical stimulation. Throughout the study, participants will undergo evaluations including dizziness severity using a visual analog scale, vestibular function tests with video head impulse testing, hearing thresholds with pure tone audiometry, and brain activity monitoring through electroencephalography. These assessments occur at several points up to 12 weeks during the treatment phase. The trial monitors safety and effectiveness closely, and participants' condition is tracked carefully during this period.
CONDITIONS
Brief Title
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with dizziness due to Meniere's disease who understand the study and agree to participate voluntarily
- Hearing loss frequency between 250 kHz and 1 kHz
- Bilateral hearing threshold averages within 65 dB HL at 500, 1000, and 2000 Hz
- Patients who have stopped other dizziness treatments for at least 2 months
- At least one vertigo attack in the 6 months before joining the study
- Normal results in tests for kidney function and electrolytes if performed
You will not qualify if you...
- Otologic conditions other than Meniere's disease, such as otitis media or profound hearing loss
- Conditions that affect EEG measurements like stroke, brain hemorrhage, or brain tumor
- Kidney disease
- Serious medical conditions including cancer, epilepsy, or neuropsychiatric disorders
- Presence of artificial implants like cochlear implants, hip joints, or pacemakers
- Women who are pregnant, nursing, or able to become pregnant
- Injuries or skin problems where the device would be applied
- Coronary artery disease, uncontrolled high blood pressure, or other serious health issues including kidney disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either electrical stimulation combined with betahistine, sham electrical stimulation combined with betahistine, or betahistine alone to modulate auditory symptoms and vertigo of Meniere's disease.
Visits at Weeks 0, 1, 2, 4, 8, and 12 during treatment
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
M
Myung-Whan Suh
D
Dong-min Kang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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