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

Primary Purpose

Meniere's Disease

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YPS-201b
betahistine
YPS-201b
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Electrical stimulation, Electroceutical, Meniere's disease

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

electircal stimulation + betahistine

sham electircal stimulation + betahistine

betahistine

Arm Description

control group

Outcomes

Primary Outcome Measures

Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Verifying therapeutic effect of electrical stimulation
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.
Valuation of hearing threshold with pure tone audiometry(Efficacy)
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
electroencephalography(Efficacy)
Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2023
Last Updated
August 17, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06001593
Brief Title
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Electrical stimulation, Electroceutical, Meniere's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electircal stimulation + betahistine
Arm Type
Experimental
Arm Title
sham electircal stimulation + betahistine
Arm Type
Sham Comparator
Arm Title
betahistine
Arm Type
Other
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
YPS-201b
Intervention Description
electrical stimulation device.
Intervention Type
Drug
Intervention Name(s)
betahistine
Intervention Description
Relieve symptoms of balance disorders or dizziness
Intervention Type
Device
Intervention Name(s)
YPS-201b
Intervention Description
sham electrical stimulation device.
Primary Outcome Measure Information:
Title
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Description
Verifying therapeutic effect of electrical stimulation
Time Frame
0,2,4,8,12 weeks during electrical stimulation
Title
Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)
Description
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.
Time Frame
0,4,8,12 weeks during electrical stimulation
Title
Valuation of hearing threshold with pure tone audiometry(Efficacy)
Description
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
Time Frame
0,4,8,12 weeks during electrical stimulation
Title
electroencephalography(Efficacy)
Description
Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.
Time Frame
0,1,4,8,12 weeks during electrical stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Whan Suh
Phone
+821039490330
Email
drmung@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-min Kang
Email
dongmin_4@naver.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Whan Suh

12. IPD Sharing Statement

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

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