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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

Tracking Information
First Submitted Date  ICMJE July 24, 2023
First Posted Date  ICMJE August 21, 2023
Last Update Posted Date August 21, 2023
Estimated Study Start Date  ICMJE September 7, 2023
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2023)
  • 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
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Meniere's Disease
Intervention  ICMJE
  • Device: YPS-201b
    electrical stimulation device.
  • Drug: betahistine
    Relieve symptoms of balance disorders or dizziness
  • Device: YPS-201b
    sham electrical stimulation device.
Study Arms  ICMJE
  • Experimental: electircal stimulation + betahistine
    Interventions:
    • Device: YPS-201b
    • Drug: betahistine
  • Sham Comparator: sham electircal stimulation + betahistine
    Interventions:
    • Drug: betahistine
    • Device: YPS-201b
  • betahistine
    control group
    Intervention: Drug: betahistine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2023)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Myung-Whan Suh +821039490330 drmung@naver.com
Contact: Dong-min Kang dongmin_4@naver.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06001593
Other Study ID Numbers  ICMJE 2304-098-1425
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Seoul National University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seoul National University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP