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Autism Spectrum DisorderTMSinASDNCT04242355

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

A study testing Transcranial Magnetic Stimulation (TMS) in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Transcranial Magnetic Stimulation (TMS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Jul 2019to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Transcranial Magnetic Stimulation (TMS)
Keywords
TMS
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic Stimulation (TMS)Behavioural

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

Study groups in NCT04242355
Study groupRoleWhat they receive
Transcranial Magnetic Stimulation - realActive comparatorParticipants will receive active TMS during their study visit
Receives: Behavioral: Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation - shamPlacebo comparatorParticipants will receive sham stimulation during their study visit simulating TMS
Receives: Behavioral: Transcranial Magnetic Stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. right lateralized N170 latency to upright faces

    EEG brain response to faces as measured by the N170 component in milliseconds

    Measured: Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.

Secondary outcomes (2)

  1. 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

    Measured: Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.

  2. The Benton Face Recognition Task

    The total Benton score will be used to assess the ability to recognize and discriminate among faces

    Measured: Measures will be recorded for the duration of their visit, an expected average of 4-5hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start1 Jul 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04242355
Sponsor's protocol ID
2000021846
Acronym
TMSinASD
Status last verified
Aug 2025
First submitted
15 Jan 2020
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19833552

  • 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.

    PubMed 15664172

  • 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.

    PubMed 10859571

  • 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.

    PubMed 15335344

  • 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.

    PubMed 14979766

  • 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.

    PubMed 24127165

  • 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.

    PubMed 29236921

  • 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.

    PubMed 28536500

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation (TMS) in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

right lateralized N170 latency to upright faces (time frame: Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04242355, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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