Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 5:13 PM
Study NCT ID:
NCT06001593
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008575', 'term': 'Meniere Disease'}], 'ancestors': [{'id': 'D018159', 'term': 'Endolymphatic Hydrops'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001621', 'term': 'Betahistine'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)', 'timeFrame': '0,2,4,8,12 weeks during electrical stimulation', 'description': 'Verifying therapeutic effect of electrical stimulation'}, {'measure': 'Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)', 'timeFrame': '0,4,8,12 weeks during electrical stimulation', '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."}, {'measure': 'Valuation of hearing threshold with pure tone audiometry(Efficacy)', 'timeFrame': '0,4,8,12 weeks during electrical stimulation', 'description': 'Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.'}, {'measure': 'electroencephalography(Efficacy)', 'timeFrame': '0,1,4,8,12 weeks during electrical stimulation', 'description': 'Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrical stimulation', 'Electroceutical', "Meniere's disease"], 'conditions': ["Meniere's Disease"]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with dizziness (Meniere's) only, who understand the nature of the study and are willing to participate voluntarily.\n* The frequency of the hearing loss is between 250 kHz and 1 kHz.\n* Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65 dB HL\n* Patients who have received conventional pharmacotherapy for other dizziness conditions with a washout period of 2 months.\n* 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.\n* If tests for renal function, electrolytes, etc. are performed and no problems are found\n\nExclusion Criteria:\n\n* Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media, profound hearing loss, hyperacusis, etc.).\n* Patients' conditions that may affect EEG measurements, such as a stroke, brain hemorrhage, or brain tumor.\n* Patients with kidney disease\n* Patients Have or have had a serious medical condition, such as cancer (including leukemia, blood cancers, epilepsy, and neuropsychiatric conditions).\n* Patients with an artificial implant in the body (cochlear implant, hip joint, pacemaker, etc.)\n* Women of childbearing potential, pregnant women, or nursing mothers\n* Patients who can have Injuries or dermatologic abnormalities at the site of application of the equipment.\n* Patients with coronary artery disease, uncontrolled high blood pressure, or other serious medical conditions (including kidney disease)."}, 'identificationModule': {'nctId': 'NCT06001593', 'briefTitle': "Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation", 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '2304-098-1425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'electircal stimulation + betahistine', 'interventionNames': ['Device: YPS-201b', 'Drug: betahistine']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham electircal stimulation + betahistine', 'interventionNames': ['Drug: betahistine', 'Device: YPS-201b']}, {'type': 'OTHER', 'label': 'betahistine', 'description': 'control group', 'interventionNames': ['Drug: betahistine']}], 'interventions': [{'name': 'YPS-201b', 'type': 'DEVICE', 'description': 'electrical stimulation device.', 'armGroupLabels': ['electircal stimulation + betahistine']}, {'name': 'betahistine', 'type': 'DRUG', 'description': 'Relieve symptoms of balance disorders or dizziness', 'armGroupLabels': ['betahistine', 'electircal stimulation + betahistine', 'sham electircal stimulation + betahistine']}, {'name': 'YPS-201b', 'type': 'DEVICE', 'description': 'sham electrical stimulation device.', 'armGroupLabels': ['sham electircal stimulation + betahistine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung-Whan Suh', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myung-Whan Suh', 'role': 'CONTACT', 'email': 'drmung@naver.com', 'phone': '+821039490330'}, {'name': 'Dong-min Kang', 'role': 'CONTACT', 'email': 'dongmin_4@naver.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}