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NCT Number: NCT06001593

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

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.

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Key information

Conditions

Meniere's Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Meniere Disease Otorhinolaryngologic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Myung-Whan Suh

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

YPS-201b

Device

electrical stimulation device.

Betahistine

Drug

Relieve symptoms of balance disorders or dizziness

Primary outcomes

  1. Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-min Kang

CONTACT

[email protected]

Myung-Whan Suh

CONTACT

[email protected]

+821039490330

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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