Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder (TMSinASD)

April 22, 2024 updated by: James C. McPartland, Yale University

Effects of Repetitive Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder

This study will evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in Autism Spectrum Disorder (ASD). Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an EEG (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of TMS.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Broad ranging social cognition difficulties are hallmark areas of impairment in autism spectrum disorder (ASD), and they are subserved by specific neural systems underpinning social perception and processing that are recognized to be atypical in ASD. Considering the neurodevelopmental nature of the disorder, and the recent findings regarding aberrant neuroplasticity in ASD, repetitive transcranial magnetic stimulation (rTMS) holds promise to directly modulate brain activity in these systems. The objective of this research proposal is to utilize a multimodal approach to provide a proof-of-concept for the ability of rTMS to (a) influence functioning in the brain systems involved in social ASD symptomatology and (b) modify associated social cognitive behaviors in adults with ASD. Toward achieving this objective, we propose to assess critical aspects of social cognition using the electroencephalogram (EEG), event-related potentials (ERPS), eye-tracking (ET), and behavioral tasks prior to and following a single rTMS session to provide preliminary insight into the potential of rTMS as a tool to modify social brain function in cognitively able adults with ASD.

Study Type

Interventional

Enrollment (Estimated)

100

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 Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

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

Description

Inclusion Criteria:

  • individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder.
  • 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 exclude

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: None (Open Label)

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 lateralized N170 latency to upright faces
Time Frame: Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.
EEG brain response to faces as measured by the N170 component in milliseconds
Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of visual attention to the eye region of the face
Time Frame: Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.
visual attention to the eye region of the face as measured by eye tracking in seconds
Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.
The Benton Face Recognition Task
Time Frame: Measures will be recorded for the duration of their visit, an expected average of 4-5hrs
The total Benton score will be used to assess the ability to recognize and discriminate among faces
Measures will be recorded for the duration of their visit, an expected average of 4-5hrs

Collaborators and Investigators

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

Sponsor

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)

July 1, 2019

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000021846

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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