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

NCT ID: NCT04936009

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2027-07-01

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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will not know whether they are receiving active or sham TMS until both sessions have been completed.

Study Groups

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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

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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

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James McPartland, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University Child Study Center

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicole Wright, BS

Role: CONTACT

203-785-3488

Adam Naples, PhD

Role: CONTACT

203-785-2583

Facility Contacts

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Nicole Wright

Role: primary

860-785-3488

References

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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)

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)

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

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Proposal No. AR200174

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000030576

Identifier Type: -

Identifier Source: org_study_id

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