Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder (ASD) Using Transcranial Magnetic Stimulation (TMS)

NCT06214065 | Recruiting FDA Device

• 4 other identifiers: HHC-2023-0203R01MH132044Assaf 1212232000039667
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Mentalizing Task Related (MTR) neural activity in the mentalizing network

  Change in MTR activity in six brain regions, from fMRI scans will be measured pre- to post-rTMS.

  during each fMRI, up to 5 hours

Study Arms (2)

ASD: excitatory, then inhibitory, then sham rTMS

EXPERIMENTAL

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.

Diagnostic Test: fMRI; Device: rTMS

Typically Developing (TD): excitatory, then inhibitory, then sham rTMS

EXPERIMENTAL

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.

Diagnostic Test: fMRI; Device: rTMS

Interventions

fMRI DIAGNOSTIC_TEST

fMRI will be performed pre- and post-rTMS

ASD: excitatory, then inhibitory, then sham rTMS; Typically Developing (TD): excitatory, then inhibitory, then sham rTMS

rTMS DEVICE

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.

ASD: excitatory, then inhibitory, then sham rTMS; Typically Developing (TD): excitatory, then inhibitory, then sham rTMS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Olin Neuropsychiatry Research Center (ONRC)

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Vaughn Steele, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Michal Assaf, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Assaf, MD

CONTACT

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

Vaughn R Steele, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Access Criteria: National Institute of Mental Health Data Archive (NDA)

Locations

US (1)