Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-02-20 @ 9:22 PM
Study NCT ID:
NCT01886092
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)', 'timeFrame': 'Change from Baseline inTinnitus Handicap Inventory at 3 months'}], 'secondaryOutcomes': [{'measure': "Beck's Depression Inventory (BDI)", 'timeFrame': 'Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention'}, {'measure': 'visual analogue scale (VAS)', 'timeFrame': 'Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tinnitus'], 'conditions': ['Tinnitus']}, 'referencesModule': {'references': [{'pmid': '32944806', 'type': 'DERIVED', 'citation': 'Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Suh MW. Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):767-775. doi: 10.1007/s10548-020-00797-y. Epub 2020 Sep 17.'}, {'pmid': '31830753', 'type': 'DERIVED', 'citation': 'Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Chung CK, Kim JS, Suh MW. Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial. Audiol Neurootol. 2019;24(6):293-298. doi: 10.1159/000503134. Epub 2019 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus', 'detailedDescription': 'Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic tinnitus\n* Chronic subjective tinnitus for more than 6 months\n* Subject is naive regarding rTMS\n* Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study\n* Stable enough to complete this study per the opinion of the Study Physician\n* No restrictions, provided the dosages have been in place for at least 3 months\n* A three month washout from any other tinnitus treatment or management program is required prior to entering this study.\n\nExclusion Criteria:\n\n* Objective tinnitus or tinnitus with treatable cause\n* Presence of intracranial or intraocular ferromagnetic materiel or particles\n* Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition\n* Personal history of central nervous system disorder, head injury, stroke or seizures\n* Familial history of epilepsy\n* Concomitant medication with antidepressants and antipsychotics\n* Pregnant women\n* Others known contraindications to rTMS or brain MRI'}, 'identificationModule': {'nctId': 'NCT01886092', 'acronym': 'rTMS', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus', 'orgStudyIdInfo': {'id': 'H-1212-081-451'}, 'secondaryIdInfos': [{'id': 'SNUHT1', 'type': 'OTHER', 'domain': 'SNUHT1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active rTMS1', 'description': 'Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex', 'interventionNames': ['Device: Active rTMS 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active rTMS2', 'description': 'Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex', 'interventionNames': ['Device: Active rTMS 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active rTMS3', 'description': 'Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex', 'interventionNames': ['Device: Active rTMS 3']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Condition', 'description': 'Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex', 'interventionNames': ['Device: sham condition']}], 'interventions': [{'name': 'Active rTMS 1', 'type': 'DEVICE', 'description': 'repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).', 'armGroupLabels': ['Active rTMS1']}, {'name': 'Active rTMS 2', 'type': 'DEVICE', 'description': 'repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects)', 'armGroupLabels': ['Active rTMS2']}, {'name': 'Active rTMS 3', 'type': 'DEVICE', 'description': 'repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)', 'armGroupLabels': ['Active rTMS3']}, {'name': 'sham condition', 'type': 'DEVICE', 'description': 'Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)', 'armGroupLabels': ['Sham Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Myung-Whan Suh, MD, ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}