- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457567
Neural Mechanisms of the Social Brain
Neural and Behavioral Correlates of Live Face-to-Face Interactions
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Part 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.
The focus of this registration is Aim 2.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joy Hirsch, PhD
- Phone Number: 9174947768
- Email: joy.hirsch@yale.edu
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06511
- Yale School of Medicine
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Contact:
- Joy Hirsch, PhD
- Phone Number: 9174947768
- Email: joy.hirsch@yale.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Self reported typically developed adults.
Exclusion Criteria:
-No prior history of seizure activity. Self reported absence of recreational drugs at time of study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham Comparator
TMS to a non-targeted region.
|
TMS to targeted regions.
Transcranial Direct Current Stimulation, tDCS, to targeted and sham regions.
|
|
Experimental: Experimental Comparator
TMS to targeted regions
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TMS to targeted regions.
Transcranial Direct Current Stimulation, tDCS, to targeted and sham regions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change in hemodynamic signals
Time Frame: Baseline and At time of measurement, approximately one hour
|
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.
|
Baseline and At time of measurement, approximately one hour
|
|
Electroencephalography (EEG) response to live face gaze
Time Frame: At time of measurement, approximately one hour
|
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.
|
At time of measurement, approximately one hour
|
|
Eye Contact Behavior
Time Frame: At time of measurement, approximately one hour
|
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.
|
At time of measurement, approximately one hour
|
|
Face Gaze Behavior
Time Frame: At time of measurement, approximately one hour
|
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.
|
At time of measurement, approximately one hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joy Hirsch, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1501015178
- 1R61MH138705-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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