Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder (ASD) Using Transcranial Magnetic Stimulation (TMS)
Part of paid clinical trials in Hartford, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT06214065
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 35 Years
- Healthy Volunteers
- Accepted
Interventions
- fMRI — DIAGNOSTIC_TESTfMRI will be performed pre- and post-rTMS
- rTMS — DEVICETMS procedures are scheduled during study sessions 2-4 between the two MRI scans on those days. Because rTMS induces neural changes that last about 1 hour, rTMS will be applied immediately before the second MRI scan on each day. Prior to the TMS visits, target coordinates and orientation vectors will be generated from the MRI data and the e-field models and loaded into Localite along with the participant's reconstructed T1 image. During the visits, the participant's head will be co-registered to the T1 using fiducial points at the Nasion and Tragi. TMS pulses will be delivered, using the Localite software to target and track the optimal orientation calculated with e-field modeling.
Study Details
The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups. Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.
Key Dates
- Start date
- Apr 3, 2024
- Status verified
- Mar 2026
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: ASD: excitatory, then inhibitory, then sham rTMSParticipants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits.
- Experimental: Typically Developing (TD): excitatory, then inhibitory, then sham rTMSParticipants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits.
Primary Outcome Measure
Mentalizing Task Related (MTR) neural activity in the mentalizing network [ Time Frame: during each fMRI, up to 5 hours ]
Central Contacts
- Michal Assaf, MD860-545-7792
- Vaughn R Steele, MD860-545-7855
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Olin Neuropsychiatry Research Center (ONRC) | Hartford | Connecticut | 06106 | - |
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