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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Autism Spectrum Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right lateralized N170 latency to upright faces | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TMS