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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT04936009
• Lead Sponsor: Yale University

Brief Summary

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-13
• Study First Submitted QC: 2021-06-13
• Study First Posted: 2021-06-23
• Study Start: 2022-03-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-01-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation - real	Transcranial Magnetic Stimulation (TMS)	Participants will receive active TMS during their study visit
Transcranial Magnetic Stimulation - sham	Transcranial Magnetic Stimulation (TMS)	Participants will receive sham stimulation during their study visit simulating TMS

Primary Outcome Measures

Name	Time	Method
right hemisphere N170 latency	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
proportion of visual attention to the eye region of the face	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

Trial Locations

Locations (1)

Yale University Child Study Center; 🇺🇸 New Haven, Connecticut, United States