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

NCT ID: NCT04242355

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2026-07-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial Magnetic Stimulation - real

Participants will receive active TMS during their study visit

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: BEHAVIORAL

Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions

Transcranial Magnetic Stimulation - sham

Participants will receive sham stimulation during their study visit simulating TMS

Group Type: PLACEBO_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: BEHAVIORAL

Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions

Interventions

Transcranial Magnetic Stimulation (TMS)

Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

James C. McPartland

Associate Professor of Child Psychiatry and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

Reference Type: BACKGROUND

PMID: 19833552 (View on PubMed)

Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

Reference Type: BACKGROUND

PMID: 15664172 (View on PubMed)

Allison T, Puce A, McCarthy G. Social perception from visual cues: role of the STS region. Trends Cogn Sci. 2000 Jul;4(7):267-278. doi: 10.1016/s1364-6613(00)01501-1.

Reference Type: BACKGROUND

PMID: 10859571 (View on PubMed)

McPartland J, Dawson G, Webb SJ, Panagiotides H, Carver LJ. Event-related brain potentials reveal anomalies in temporal processing of faces in autism spectrum disorder. J Child Psychol Psychiatry. 2004 Oct;45(7):1235-45. doi: 10.1111/j.1469-7610.2004.00318.x.

Reference Type: BACKGROUND

PMID: 15335344 (View on PubMed)

Dawson G, Toth K, Abbott R, Osterling J, Munson J, Estes A, Liaw J. Early social attention impairments in autism: social orienting, joint attention, and attention to distress. Dev Psychol. 2004 Mar;40(2):271-83. doi: 10.1037/0012-1649.40.2.271.

Reference Type: BACKGROUND

PMID: 14979766 (View on PubMed)

Oberman LM, Rotenberg A, Pascual-Leone A. Use of transcranial magnetic stimulation in autism spectrum disorders. J Autism Dev Disord. 2015 Feb;45(2):524-36. doi: 10.1007/s10803-013-1960-2.

Reference Type: BACKGROUND

PMID: 24127165 (View on PubMed)

Abujadi C, Croarkin PE, Bellini BB, Brentani H, Marcolin MA. Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study. Braz J Psychiatry. 2018 Jul-Sep;40(3):309-311. doi: 10.1590/1516-4446-2017-2279. Epub 2017 Dec 11.

Reference Type: BACKGROUND

PMID: 29236921 (View on PubMed)

Ni HC, Hung J, Wu CT, Wu YY, Chang CJ, Chen RS, Huang YZ. The Impact of Single Session Intermittent Theta-Burst Stimulation over the Dorsolateral Prefrontal Cortex and Posterior Superior Temporal Sulcus on Adults with Autism Spectrum Disorder. Front Neurosci. 2017 May 9;11:255. doi: 10.3389/fnins.2017.00255. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28536500 (View on PubMed)

Other Identifiers

2000021846

Identifier Type: -

Identifier Source: org_study_id