Status:
RECRUITING
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
Lead Sponsor:
Seoul National University Hospital
Conditions:
Meniere's Disease
Eligibility:
All Genders
19-80 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06001593
Start Date
September 18 2023
End Date
December 31 2025
Last Update
December 5 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea