Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:30 AM
Study NCT ID:
NCT07457567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Mechanisms of the Social Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in hemodynamic signals', 'timeFrame': 'Baseline and At time of measurement, approximately one hour', 'description': 'Statistical comparison of measures before and after stimulation. Measurement of brain oxygenation during cognitive assessment. The variable of interest will be changes in fNIRS oxyhemoglobin and deoxyhemoglobin signals (% change from baseline) during the cognitive assessment.'}, {'measure': 'Electroencephalography (EEG) response to live face gaze', 'timeFrame': 'At time of measurement, approximately one hour', 'description': 'Statistical comparison of measures before and after stimulation. EEG response to live face gaze is acquired for frequencies between 1 and 20 Hz. Oscillatory signals will be partitioned into Theta (4-8 Hz) and Alpha (8-12 Hz) frequencies for comparisons before and after TMS. Higher values indicate better score.'}, {'measure': 'Eye Contact Behavior', 'timeFrame': 'At time of measurement, approximately one hour', 'description': 'Statistical comparison of measures before and after stimulation (amplitude). Free viewing Eye tracking measures are detected by light reflections acquired at 120 Hz. Eye to eye contact is computationally determined by comparison of the eye tracking measures between the two partners.'}, {'measure': 'Face Gaze Behavior', 'timeFrame': 'At time of measurement, approximately one hour', 'description': 'Statistical comparison of measures before and after stimulation (Action Units). Facial dynamics are quantified by rapid photography and AI programs (OpenFace) that classify categories of facial expressions. There are 17 facial expressions that will be acquired during the face gaze conditions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Live Face Processing in Typically Developed Participants']}, 'descriptionModule': {'briefSummary': 'This study aims to understand the neural mechanisms that underlie synchronization of two brains during social interactions.', 'detailedDescription': 'After being informed about the study and potential risks, all participants giving written informed consent will undergo a structural MRI image for anatomical localization of the targeted stimulation site. Participants will be randomly assigned to one of two TMS target locations, and will be identified for the TMS experiments. Two to three days prior to the TMS experiment, participants will undergo a before TMS/fNIRS experiment. On the day of the TMS experiment participants will undergo a functional dyadic neuroimaging session after TMS stimulation. For the neuromodulation experiments, tDCS, selected sites for stimulation will be identified on the T1 anatomical scans for each participant who will be randomly assigned to one of three groups. In each case the face-gaze fNIRS experiment will be run. Aim 2: Two targeted sites will be confirmed as neural hubs by modification of fiducial neural regions based on the findings of cTBS disruptions. Rationale: These locations and functional specializations are necessary for the proposed neuromodulation tests in the upcoming clinical trial phase.\n\nPart 1: Stimulate to disrupt the site associated with eye-to-eye contact hypothesized to be right superior parietal lobule. Part 2: Stimulate to disrupt the site associated with live face gaze hypothesized to be right supramarginal gyrus.\n\nThe focus of this registration is Aim 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Self reported typically developed adults.\n\nExclusion Criteria:\n\n-No prior history of seizure activity. Self reported absence of recreational drugs at time of study.'}, 'identificationModule': {'nctId': 'NCT07457567', 'briefTitle': 'Neural Mechanisms of the Social Brain', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Neural and Behavioral Correlates of Live Face-to-Face Interactions', 'orgStudyIdInfo': {'id': '1501015178'}, 'secondaryIdInfos': [{'id': '1R61MH138705-01', 'link': 'https://reporter.nih.gov/quickSearch/1R61MH138705-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator', 'description': 'TMS to a non-targeted region.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Comparator', 'description': 'TMS to targeted regions', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'description': 'TMS to targeted regions. Transcranial Direct Current Stimulation, tDCS, to targeted and sham regions.', 'armGroupLabels': ['Experimental Comparator', 'Sham Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'contacts': [{'name': 'Joy Hirsch, PhD', 'role': 'CONTACT', 'email': 'joy.hirsch@yale.edu', 'phone': '9174947768'}], 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Joy Hirsch, PhD', 'role': 'CONTACT', 'email': 'joy.hirsch@yale.edu', 'phone': '9174947768'}], 'overallOfficials': [{'name': 'Joy Hirsch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'url': 'http://datadryad.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Upon completion of the study. The data will be available in perpetuity.', 'ipdSharing': 'YES', 'description': 'All data will be available on DRYAD, a public database', 'accessCriteria': 'Access to the internet to access DRYAD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}