Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT02674516
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2016-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000987', 'term': 'Antisocial Personality Disorder'}, {'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oliviachoy@ntu.edu.sg', 'phone': '(65) 65921522', 'title': 'Dr. Olivia Choy', 'organization': 'Nanyang Technological University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 hours after the end of the first stimulation session', 'eventGroups': [{'id': 'EG000', 'title': 'Anodal Stimulation', 'description': 'Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.\n\nTranscranial direct current stimulation', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Stimulation', 'description': 'The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.\n\nSham transcranial direct current stimulation', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 8, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pinching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anodal Stimulation', 'description': 'Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.\n\nTranscranial direct current stimulation'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.\n\nSham transcranial direct current stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '3.77', 'spread': '8.88', 'groupId': 'OG000'}, {'value': '.64', 'spread': '1.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On average, 48 hours after the first 20-minute tDCS or sham session ends', 'description': 'The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded.', 'unitOfMeasure': 'pins', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anodal Stimulation', 'description': 'Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.\n\nTranscranial direct current stimulation'}, {'id': 'FG001', 'title': 'Sham Stimulation', 'description': 'The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.\n\nSham transcranial direct current stimulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Knowledge of study hypothesis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anodal Stimulation', 'description': 'Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.\n\nTranscranial direct current stimulation'}, {'id': 'BG001', 'title': 'Sham Stimulation', 'description': 'The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.\n\nSham transcranial direct current stimulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.15', 'spread': '10.77', 'groupId': 'BG000'}, {'value': '33.27', 'spread': '14.10', 'groupId': 'BG001'}, {'value': '32.13', 'spread': '12.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-07', 'size': 94595, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-06T23:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2016-01-26', 'resultsFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-07', 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours', 'timeFrame': 'On average, 48 hours after the first 20-minute tDCS or sham session ends', 'description': 'The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antisocial behavior', 'aggression', 'transcranial direct current stimulation', 'dorsolateral prefrontal cortex', 'associated risk factors'], 'conditions': ['Antisocial Behavior', 'Aggression']}, 'descriptionModule': {'briefSummary': 'This study investigates the relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors. Heart rate and skin conductance will also be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years of age\n* Able to understand the nature of the study and give informed consent\n\nExclusion Criteria:\n\n* Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications\n* Currently consuming anti-depressants\n* History of seizures\n* Metallic implants on the scalp\n* Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day\n* History of adverse reactions to tDCS'}, 'identificationModule': {'nctId': 'NCT02674516', 'briefTitle': 'The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'The Effect of Repeated Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior', 'orgStudyIdInfo': {'id': '823967'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal stimulation', 'description': 'Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.', 'interventionNames': ['Device: Transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.', 'interventionNames': ['Device: Sham transcranial direct current stimulation']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Anodal stimulation']}, {'name': 'Sham transcranial direct current stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Adrian Raine, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}