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

Meniere's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001593
• Other study ID #: 2304-098-1425
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: Myung-Whan Suh
• Phone: +821039490330
• Email: drmung[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 controlling auditory symptoms and dizziness in patients with Meniere's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease
• Vertigo

Intervention

Device:
• YPS-201b
electrical stimulation device.

Drug:
• betahistine
Relieve symptoms of balance disorders or dizziness

Device:
• YPS-201b
sham electrical stimulation device.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)	Verifying therapeutic effect of electrical stimulation	0,2,4,8,12 weeks during electrical stimulation
Primary	Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)	Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.	0,4,8,12 weeks during electrical stimulation
Primary	Valuation of hearing threshold with pure tone audiometry(Efficacy)	Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.	0,4,8,12 weeks during electrical stimulation
Primary	electroencephalography(Efficacy)	Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.	0,1,4,8,12 weeks during electrical stimulation