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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06001593
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 7, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
betahistine
control group
 Drug: betahistine
Relieve symptoms of balance disorders or dizziness


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001593


Contacts
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Contact: Myung-Whan Suh +821039490330 drmung@naver.com
Contact: Dong-min Kang dongmin_4@naver.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Myung-Whan Suh         
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT06001593    
Other Study ID Numbers: 2304-098-1425
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: July 2023

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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:
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Vertigo
Meniere Disease
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
 Endolymphatic Hydrops
Betahistine
Vasodilator Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs