Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT03628703
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Response Inhibition in Tourette Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005879', 'term': 'Tourette Syndrome'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013981', 'term': 'Tic Disorders'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'steve.wu@cchmc.org', 'phone': '513-636-4222', 'title': 'Steve W. Wu, M.D.', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Repetitive TMS', 'description': 'Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation\n\nRepetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stop Signal Reaction Time (SSRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Repetitive TMS', 'description': 'Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation\n\nRepetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area'}], 'classes': [{'title': 'Before Repetitive TMS', 'categories': [{'measurements': [{'value': '249', 'spread': '28.0', 'groupId': 'OG000'}]}]}, {'title': 'After Repetitive TMS', 'categories': [{'measurements': [{'value': '245', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after Repetitive Transcranial Magnetic Stimulation (as it takes about 30 minutes to complete the modified Slater-Hammel stop signal task)', 'description': 'SSRT measured from modified Slater-Hammel stop signal task performance. The SSRT is calculated by subtracting the average stop signal delay (msec) from the average go-trial reaction time. The SSRT is a measure of inhibitory behavior. The lower the SSRT value means a person is better at inhibitory control. The higher the SSRT value means a person is worse at inhibitory control.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Repetitive TMS', 'description': 'Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation\n\nRepetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Repetitive TMS', 'description': 'Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation\n\nRepetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Yale Global Tic Severity Scale', 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The score presented is the total tic severity score, ranging from 0 to 50. A score of 0 is when someone has no tics. A score of 50 is the maximal score for someone with multiple severe tics.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-02', 'size': 747909, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-18T05:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2018-08-10', 'resultsFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stop Signal Reaction Time (SSRT)', 'timeFrame': '30 minutes after Repetitive Transcranial Magnetic Stimulation (as it takes about 30 minutes to complete the modified Slater-Hammel stop signal task)', 'description': 'SSRT measured from modified Slater-Hammel stop signal task performance. The SSRT is calculated by subtracting the average stop signal delay (msec) from the average go-trial reaction time. The SSRT is a measure of inhibitory behavior. The lower the SSRT value means a person is better at inhibitory control. The higher the SSRT value means a person is worse at inhibitory control.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tourette Syndrome']}, 'descriptionModule': {'briefSummary': 'Tics are the hallmark symptoms in Tourette Syndrome. Patients with Tourette Syndrome have difficulties controlling unwanted movements. The ability to control the motor system involves the pre-supplementary motor area (pre-SMA) in the brain. In this study, we will use Transcranial Magnetic Stimulation to modulate the pre-SMA and determine effect on the ability to stop an unwanted action in a behavior task (stop signal task).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tourette Syndrome\n\nExclusion Criteria:\n\n* Autism spectrum disorder\n* Mood disorder\n* Epilepsy\n* Implanted medical device (e.g. pacemaker, shunt, pumps)'}, 'identificationModule': {'nctId': 'NCT03628703', 'briefTitle': 'Response Inhibition in Tourette Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Using Repetitive Transcranial Magnetic Stimulation to Modulate Response Inhibition in Tourette Syndrome', 'orgStudyIdInfo': {'id': 'CIN001 - TAA2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repetitive TMS', 'description': 'Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation', 'interventionNames': ['Device: Repetitive TMS']}], 'interventions': [{'name': 'Repetitive TMS', 'type': 'DEVICE', 'description': 'Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area', 'armGroupLabels': ['Repetitive TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Steve W. Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}