Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 1:16 PM
Study NCT ID:
NCT04262050
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined tDCS and TMS on Subjective Tinnitus and Combined Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D055909', 'term': 'Magnetic Field Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus handicap inventory', 'timeFrame': 'the same 1 day after treatment', 'description': 'tinnitus-related questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Tinnitus, tDCS, TMS'], 'conditions': ['Tinnitus', 'Depression']}, 'descriptionModule': {'briefSummary': 'The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.', 'detailedDescription': 'To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. Experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal area and TMS stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (Hz) stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital\n\nExclusion Criteria:\n\n* psychoactive drug user\n* implanted material\n* pacemaker user'}, 'identificationModule': {'nctId': 'NCT04262050', 'briefTitle': 'Combined tDCS and TMS on Subjective Tinnitus and Combined Depression', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Combination Transcranial Direct Current Stimulation and Transcranial Magnetic Stimulation on Subjective Tinnitus and Combined Depression', 'orgStudyIdInfo': {'id': 'B-1607/355-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMS + tDCS group', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'sham TMS + tDCS group', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS group', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'TMS group', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)']}], 'interventions': [{'name': 'transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)', 'type': 'DEVICE', 'armGroupLabels': ['TMS + tDCS group', 'TMS group', 'sham TMS + tDCS group', 'tDCS group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Jin Song', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}