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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06001593
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 27.8
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Meniere's Disease	Device: YPS-201b; Drug: betahistine; Device: YPS-201b	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Sep 7, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: electircal stimulation + betahistine	Device: YPS-201b; electrical stimulation device.; Drug: betahistine; Relieve symptoms of balance disorders or dizziness
Sham Comparator: sham electircal stimulation + betahistine	Drug: betahistine; Relieve symptoms of balance disorders or dizziness; Device: YPS-201b; sham electrical stimulation device.
Other: betahistine control group	Drug: betahistine; Relieve symptoms of balance disorders or dizziness

Outcome Measures

Primary Outcome Measures

1. Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy) [0,2,4,8,12 weeks during electrical stimulation]

   Verifying therapeutic effect of electrical stimulation

2. Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy) [0,4,8,12 weeks during electrical stimulation]

   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.

3. Valuation of hearing threshold with pure tone audiometry(Efficacy) [0,4,8,12 weeks during electrical stimulation]

   Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.

4. electroencephalography(Efficacy) [0,1,4,8,12 weeks during electrical stimulation]

   Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT06001593
• Other Study ID Numbers: 2304-098-1425
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seoul National University Hospital: Electrical stimulation; Electroceutical; Meniere's disease
• Additional relevant MeSH terms: Vertigo; Meniere Disease; Betahistine

Study Results

No Results Posted as of Aug 21, 2023