Non-invasive electrical stimulation for Meniere's disease symptoms

Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial

This study is testing if a non-invasive electrical treatment can help people with Meniere's disease feel less dizzy and improve their hearing symptoms.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06001593 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of non-invasive electrical stimulation applied to the mastoid area behind the ear in alleviating auditory symptoms and vertigo associated with Meniere's disease. It is a double-blind, randomized, sham-controlled trial, meaning that neither the participants nor the researchers know who is receiving the actual treatment versus a placebo. The study aims to recruit patients experiencing dizziness due to Meniere's disease who have not responded adequately to conventional pharmacotherapy. Participants will be monitored for changes in their symptoms over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are patients with Meniere's disease experiencing dizziness and who meet specific audiometric criteria.

Not a fit: Patients with other otologic conditions or serious medical issues that could interfere with the study may not benefit.

Why it matters

Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients suffering from Meniere's disease.

How similar studies have performed: While there have been studies on electrical stimulation for various conditions, this specific approach for Meniere's disease is relatively novel.

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 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).

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Myung-Whan Suh

Conditions: Meniere's Disease, Electrical stimulation, Electroceutical, Meniere's disease