Transcranial Magnetic Stimulation (TMS) Study for Adults With Autism Spectrum Disorder (ASD)

April 6, 2023 updated by: Yale University

Noninvasive Brain Stimulation to Treat Core Social Deficits in Autism Spectrum Disorder

This is a randomized interventional study designed to evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (ASD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to determine whether rTMS increases the brain response to faces in a population of adults with ASD. This study will assess critical aspects of social cognition using the electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single rTMS session (or Sham) to provide preliminary insight into the potential of rTMS as a tool to modify social brain function in this population.

Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and a pre and post TMS session with EEG (electroencephalogram) and eye-tracking to measure neural and visual attentional social response. Two study visits will be scheduled for each participant lasting approximately 4-5hrs total.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University Child Study Center
        • Contact:
        • Sub-Investigator:
          • Adam Naples, PhD
        • Principal Investigator:
          • James McPartland, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder.
  • Individuals able to participate in an EEG and eye-tracking experiment.

Exclusion Criteria:

  • Participants reporting significant head trauma or serious brain illness.
  • Participants with major psychiatric illness that would preclude completion of study measures.
  • Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of seizures.
  • Participants taking prescription medications that may affect cognitive processes under study.
  • Participants who have taken alcohol or recreational drugs within the preceding 24 hours.
  • Females of known/suspected pregnancy or who test positive on a pregnancy test.
  • Participants with a history of metalworking or injury by shrapnel or metallic objects are also excluded.
  • Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit.
  • Participants with an IQ (intelligence quotient) below 80.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcranial Magnetic Stimulation - real
Participants will receive active TMS during their study visit
Behavioral: Transcranial Magnetic Stimulation (TMS)
Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions
Placebo Comparator: Transcranial Magnetic Stimulation - sham
Participants will receive sham stimulation during their study visit simulating TMS
Behavioral: Transcranial Magnetic Stimulation (TMS)
Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
right hemisphere N170 latency
Time Frame: Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours
EEG brain response to faces as measured by the N170 component in milliseconds
Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours
proportion of visual attention to the eye region of the face
Time Frame: Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours
visual attention to the eye region of the face as measured by eye tracking in seconds
Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: James McPartland, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

June 13, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000030576
  • Proposal No. AR200174 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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