Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-03-29 @ 11:36 AM
Study NCT ID:
NCT02071732
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2014-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-25', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus handicap inventory score', 'timeFrame': 'Before (- six months) and after (+ 5 days) rTMS interventions', 'description': 'Primary outcomes will be measured twice. One is before, and the other is after 5-day rTMS interventions. Baseline primary outcome will be acceptable if it is done within the prior 6 months of 1st rTMS. Follow-up primary outcome will be done within the five days after 5th rTMS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients With Subjective Tinnitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of tinnitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjective tinnitus\n* Age 18 years and older\n\nExclusion Criteria:\n\n* Meniere, conductive hearing loss, objective tinnitus\n* History of seizure disorder or epilepsy\n* Clinically relevant psychiatric comorbidity\n* Previous symptomatic stroke\n* Surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation'}, 'identificationModule': {'nctId': 'NCT02071732', 'briefTitle': 'Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Dongtan Sacred Heart Hospital'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) Effect on Tinnitus', 'orgStudyIdInfo': {'id': '2014-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Real rTMS', 'description': 'Real rTMS is real continuous theta burst stimulation.', 'interventionNames': ['Device: real repetitive Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Sham rTMS is sham continuous theta burst stimulation.', 'interventionNames': ['Device: sham repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'real repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Real rTMS']}, {'name': 'sham repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'This sham stimulation is not true stimulation.', 'armGroupLabels': ['Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '445-907', 'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Department of Neurology, and Department of Otorhinolaryngology-Head & Neck Surgery Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongtan Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical professor', 'investigatorFullName': 'Suk Yun Kang', 'investigatorAffiliation': 'Dongtan Sacred Heart Hospital'}}}}