Recruiting

TMS

Sponsor:

Yale University

Code:

NCT06214065

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

fMRI

rTMS

Study Details

Brief summary:

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT06214065

Start date

Apr 3, 2024

Status verified date

Mar, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Estimated full-scale IQ>80
  • Right handed
  • Fluent in English
  • Individual can cooperate with all study's procedures
  • No history of neurological disorder (e.g. epilepsy) or neurosurgery
  • No major medical condition (e.g. cancer, heart failure)
  • No history of significant head injury
  • No primary relatives with history of any neurological disorder with a potentially hereditary basis, including epilepsy or MS
  • No current use of medications with psychotropic (e.g., benzodiazepines) or anti- or pro-convulsants
  • No current substance use (determined by urine screen and breathalyzer in all visits)
  • Negative urine pregnancy (women) test at time of MRI scans
  • No MR contra-indications (e.g. in-body metal implant, severe claustrophobia)
  • No previous participation in our lab in a study including the Domino fMRI task
  • For ASD: Stable medication treatment 4 weeks prior to study enrollment
  • For Control Group: No current or history of psychiatric disorders, other than simple phobia, and/or primary relatives with ASD

Exclusion Criteria:

\-

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: ASD: excitatory, then inhibitory, then sham rTMS

Participants 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 rTMS

Participants 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.

Interventions

fMRI

fMRI will be performed pre- and post-rTMS

rTMS

TMS 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.

Primary outcome measure

  • Mentalizing Task Related (MTR) neural activity in the mentalizing network [ Time Frame: during each fMRI, up to 5 hours ]

Central Contacts and Locations

Central contacts

Michal Assaf, MD

860-545-7792michal.assaf@hhchealth.org

Vaughn R Steele, MD

860-545-7855vaughn.steele@yale.edu

Locations

Olin Neuropsychiatry Research Center (ONRC)

Recruiting

Hartford, Connecticut, United States, 06106

More Information

Sponsor

Yale University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-27.