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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Transcranial Magnetic Stimulation (TMS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right hemisphere N170 latency | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation