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

Yale University logo

Yale University

Status

Active, not recruiting

Conditions

Autism Spectrum Disorder

Treatments

Behavioral: Transcranial Magnetic Stimulation (TMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT04242355
2000021846

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 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.
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

100 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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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