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

Yale University

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04936009

Proposal No. AR200174 (Other Grant/Funding Number)

2000030576

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Transcranial Magnetic Stimulation - real

Active Comparator group

Description:

Participants will receive active TMS during their study visit

Treatment:

Behavioral: Transcranial Magnetic Stimulation (TMS)

Transcranial Magnetic Stimulation - sham

Placebo Comparator group

Description:

Participants will receive sham stimulation during their study visit simulating TMS

Treatment:

Behavioral: Transcranial Magnetic Stimulation (TMS)