Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-02-06 @ 9:20 AM
Study NCT ID:
NCT01877161
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2013-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'njpaik@snu.ac.kr', 'phone': '031-787-7731', 'title': 'Nam-Jong Paik', 'phoneExt': '7731', 'organization': 'Seoul National University Bundang Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'during the stimulation and till the end of study participation', 'eventGroups': [{'id': 'EG000', 'title': 'Middle Temporal Gyrus', 'description': 'Repetitive magnetic stimulation to middle temporal gyrus\n\nRepetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Repetitive magnetic stimulation (Sham)\n\nRepetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham)', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Superior Temporal Gyrus', 'description': 'Repetitive magnetic stimulation to superior temporal gyrus\n\nRepetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS Over MTG', 'description': 'Repetitive magnetic stimulation (rTMS) were applied over MTG'}, {'id': 'OG001', 'title': 'rTMS Over STG', 'description': 'Repetitive magnetic stimulation (rTMS) were applied over STG'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'The coil was placed perpendicularly to the scalp during sham rTMS sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '110.65', 'spread': '102.97', 'groupId': 'OG000'}, {'value': '-14.25', 'spread': '105.78', 'groupId': 'OG001'}, {'value': '25.29', 'spread': '109.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)', 'description': 'Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).\n\nResponse times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.\n\nThe "reaction time post TMS - reaction time pre TMS" were used for analysis.\\* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rTMS Over MTG, STG, Sham', 'description': '3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.\n\ndifferent sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions.'}], 'periods': [{'title': 'First Session of Stimulation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (at Least 3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Second Session of Stimulation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (at Least 3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Third Session of Stimulation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment period : 2012.12.05-2013.03.07 type of location: medical clinic through public announcement', 'preAssignmentDetails': '15 participants recruited: 15 screened, 0 excluded, 3 participants dropped out (3 participants withdrew because of their long-distance commute before group assignment)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'rTMS Over MTG, STG, Sham', 'description': '3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.\n\n3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus\n\nThe sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.87', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '47'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Same patients were stimulated over 2 different regions and with sham stimulation in a random order'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2013-03-11', 'resultsFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-20', 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)', 'timeFrame': 'change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)', 'description': 'Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).\n\nResponse times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.\n\nThe "reaction time post TMS - reaction time pre TMS" were used for analysis.\\* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG'}]}, 'conditionsModule': {'conditions': ['To Healthy Volunteer', 'Virtual Lesions for Aphasia']}, 'descriptionModule': {'briefSummary': 'Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.', 'detailedDescription': 'To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fluent in Korean\n* older than 18 years old\n\nExclusion Criteria:\n\n* younger than 18 years old\n* psychotic or psychiatric problems\n* pregnant\n* contraindications to MRI/fMRI\n* uncooperative\n* metalic implants, pacemaker or cochlear implants\n* cannot perform outcome measure-related task\n* known seizure history'}, 'identificationModule': {'nctId': 'NCT01877161', 'briefTitle': 'Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types', 'orgStudyIdInfo': {'id': 'E-1206-158-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Middle temporal gyrus', 'description': 'Repetitive magnetic stimulation to middle temporal gyrus', 'interventionNames': ['Device: Repetitive magnetic stimulation to middle temporal gyrus']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Repetitive magnetic stimulation (Sham)', 'interventionNames': ['Device: Repetitive magnetic stimulation (Sham)']}, {'type': 'EXPERIMENTAL', 'label': 'Superior temporal gyrus', 'description': 'Repetitive magnetic stimulation to superior temporal gyrus', 'interventionNames': ['Device: Repetitive magnetic stimulation to superior temporal gyrus']}], 'interventions': [{'name': 'Repetitive magnetic stimulation to superior temporal gyrus', 'type': 'DEVICE', 'otherNames': ['MagPro X100 magnetic stimulator'], 'description': 'Repetitive magnetic stimulation to superior temporal gyrus', 'armGroupLabels': ['Superior temporal gyrus']}, {'name': 'Repetitive magnetic stimulation to middle temporal gyrus', 'type': 'DEVICE', 'otherNames': ['MagPro X100 magnetic stimulator'], 'description': 'Repetitive magnetic stimulation to middle temporal gyrus', 'armGroupLabels': ['Middle temporal gyrus']}, {'name': 'Repetitive magnetic stimulation (Sham)', 'type': 'DEVICE', 'otherNames': ['MagPro X100 magnetic stimulator'], 'description': 'Repetitive magnetic stimulation (Sham)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Bundang-gu', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Nam-Jong Paik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nam-Jong Paik', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}