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New treatment option for Meniere's Disease
Official title Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
ClinicalTrials.gov ID: NCT06001593
What this study is testing
What is betahistine?
betahistine is an investigational medicine, being studied as a potential treatment for meniere's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- 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 people in the active phase of the disease, there must be at least 1 vertigo attack in the 6 months before study entry.
You likely can't join if
- 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
See the full eligibility 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 people 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.