Meniere's Disease
Conditions
Keywords
Electrical stimulation, Electroceutical, Meniere's disease
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.
Interventions
DEVICEYPS-201b
electrical stimulation device.
DRUGbetahistine
Relieve symptoms of balance disorders or dizziness
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactMyung-Whan Suh
Backup ContactDong-min Kang
Outcome results
None listed