- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07177261
- Original Trial
Inter-Brain Synchrony in Schizophrenia
Inter-Brain Synchrony as a Neural Mechanism of Social Connection in Schizophrenia
The goal of this clinical trial is to investigate for the first time in people with schizophrenia a neural mechanism that is thought to facilitate the formation of social connections - inter-brain synchrony - in order to improve scientific understanding of the neural mechanisms of social dysfunction in the disorder, and to provide a basis for the development of new and better treatments to improve social functioning and connectedness in the illness. The main questions it aims to answer are:
- Investigate inter-brain synchrony as a neural mechanism of social connection in schizophrenia
- Manipulate social closeness and test for effects on inter-brain synchrony across groups
The investigators will compare results from people with schizophrenia to a healthy comparison group (controls) who do not have psychotic disorders to see if inter-brain synchrony is greater in controls. Investigators will also compare measures of inter-brain synchrony before and after the social closeness manipulation to see if inter-brain synchrony changes with increasing closeness.
Participants will:
- Have a clinicial diagnostic interview and be assessed for clinical symptoms
- Have an EEG recorded while interacting with another person. Participants will first work with the other person to draw a figure, and then tap fingers together. Participants will then either undergo the experimental manipulation to increase social closeness (called, "fast friends") or undergo the control condition that does not increase social closeness (called "small talk"). Participants will then repeat the drawing and finger tapping assessment.
- After completing the experimental or control condition, participants will then repeat the procedure with the other condition that was not yet done.
- Be interviewed on the number and quality of social interactions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Reavis, PhD
- Phone Number: 310-206-8557
- Email: ereavis@ucla.edu
Study Contact Backup
- Name: Jonathan K Wynn, PhD
- Phone Number: 44957 310-478-3711
- Email: jkwynn@ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Jonathan K Wynn, PhD
- Phone Number: 44957 310-478-3711
- Email: jkwynn@ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- sufficient English fluency to comprehend procedures
- clinical group will include individuals with a DSM-5 diagnosis of schizophrenia who are clinically stable (outpatients, with no hospitalizations 3 months prior to enrollment and no medication changes 1 month prior to enrollment)
- members of the community without a psychotic disorder, schizophrenia-spectrum disorder, or current major mood disorder, nor history of a first-degree relative with a psychotic disorder.
Exclusion Criteria:
- evidence of IQ < 70 or developmental disability
- history of significant neurological disease, serious head injury, or significant current substance use (moderate or severe substance use disorder in the last 3 months, positive urine toxicology screen on the day of assessment, or sedatives/anxiolytics taken within 12 hours of the assessment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fast Friends
Participants will interact with another person while both have their EEG recorded.
Participants will ask and answer 12 questions with the other person that become increasingly personal in nature, e.g., "When did you last cry in front of another person?
By yourself?"
|
Participants will interact with another person while both have their EEG recorded.
They will ask and answer 12 questions with the other person that become increasingly personal in nature, e.g., "When did you last cry in front of another person?
By yourself?"
|
|
Active Comparator: Small Talk
Participants will interact with another person while both have their EEG recorded.
Participants will ask and answer 12 impersonal questions with the other person , e.g., "Do you prefer digital watches and clocks or the kind with hands?
Why?"
|
Participants will interact with another person while both have their EEG recorded.
They will ask and answer 12 impersonal questions with the other person , e.g., "Do you prefer digital watches and clocks or the kind with hands?
Why?"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interbrain synchrony
Time Frame: Interbrain synchrony will be measured immediately before and immediately following the procedure.
|
Circular correlations for 8-10Hz activity across electrodes and dyads
|
Interbrain synchrony will be measured immediately before and immediately following the procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Network Analysis
Time Frame: Measured at the start of the study only
|
Measures of social and family social connections.
Participants will be interviewed about the number of social and family connections they have, and if these contacts also know others identified by the participant.
These connections will be analyzed with graph network analyses to determine the size and quality of social connections.
|
Measured at the start of the study only
|
|
Behavioral measures of synchrony
Time Frame: Investigators will measure these during each of the two maniuplations (small talk and fast friends).
|
Investigators will video record interactions between dyads (including voice, body, face) and measure behavioral measures of synchrony
|
Investigators will measure these during each of the two maniuplations (small talk and fast friends).
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric Reavis, Phd, University of California, Los Angeles
- Principal Investigator: Jonathan K Wynn, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
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
- IRB-25-1279
- 1R21MH139044-01A1 (U.S. NIH Grant/Contract: National Institutes of Mental Health)
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
- ICF
- ANALYTIC_CODE
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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