Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
Recruiting
Phase 1Phase 2Interventional Study
Meniere's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Seoul National University Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
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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.
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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 …
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).
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