Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-21 @ 12:17 PM
Study NCT ID:
NCT03027869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Brain Imaging Database for Brain Disorder Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional connectivity', 'timeFrame': 'immediate (less than 30 minutes)', 'description': 'The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.'}], 'secondaryOutcomes': [{'measure': 'Stroop task performance', 'timeFrame': 'immediate (less than 60 minutes)', 'description': 'the executive function that is thought to involve the caudate nucleus will be examined'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* N/A\n\nExclusion Criteria:\n\n* History of any neurological or psychiatric diseases;\n* Abnormal MRI;\n* metal implants or a cardiac pacemaker;\n* Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).\n* severe hypertension.\n* cardiovascular disease.\n* Family history of epilepsy.'}, 'identificationModule': {'nctId': 'NCT03027869', 'acronym': 'Normal_tDCS', 'briefTitle': 'Normal Brain Imaging Database for Brain Disorder Studies', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Normal Brain Imaging Database for Brain Disorder Studies', 'orgStudyIdInfo': {'id': 'B2016:074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Real Left DLPFC tDCS', 'description': 'Real tDCS on the left dorsolateral prefrontal cortex', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': '30sec ramp-up and 30sec ramp-down', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Real Right DLPFC tDCS', 'description': 'Real tDCS on the right dorsolateral prefrontal cortex', 'interventionNames': ['Device: transcranial direct current stimulation']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'description': '15 minute anodal stimulation 1.5mA', 'armGroupLabels': ['Real Left DLPFC tDCS', 'Real Right DLPFC tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 0J9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ji Hyun Ko, PhD', 'investigatorAffiliation': 'University of Manitoba'}}}}