Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with Meniere's disease, which can cause dizziness and hearing problems. The study is testing a method called non-invasive electrical stimulation, which means it uses gentle electric signals applied behind the ear to see if it can improve symptoms like dizziness and hearing loss. This is a double-blind trial, meaning neither the participants nor the researchers will know who is receiving the real treatment and who is getting a placebo (a dummy treatment) to ensure fair results.

To participate in this trial, you need to have dizziness related to Meniere's disease and some hearing loss, but you should not have other ear conditions or serious health issues that could interfere with the study. The trial is open to adults aged 18 to 80 who have experienced at least one dizzy spell in the past six months. If you join, you can expect to receive either the active treatment or a placebo over a set period and will help researchers learn more about how this new approach might help others in the future. It's important to know that this study is still recruiting participants, so there's an opportunity to take part in early research that could lead to new treatment options.

Gender

ALL

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).