NCT04936009

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2022Jul 2027

First Submitted

Initial submission to the registry

June 13, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

March 17, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

June 13, 2021

Last Update Submit

February 4, 2026

Conditions

Autism Spectrum Disorder

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

  • right hemisphere N170 latency

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

    Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours

  • 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

    Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours

Study Arms (2)

Transcranial Magnetic Stimulation - real

ACTIVE COMPARATOR

Participants will receive active TMS during their study visit

Behavioral: Transcranial Magnetic Stimulation (TMS)

Transcranial Magnetic Stimulation - sham

PLACEBO COMPARATOR

Participants will receive sham stimulation during their study visit simulating TMS

Behavioral: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS)BEHAVIORAL

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

Transcranial Magnetic Stimulation - realTranscranial Magnetic Stimulation - sham

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University Child Study Center

New Haven, Connecticut, 06520, United States

RECRUITING

Related Publications (8)

  • 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.

    PMID: 19833552BACKGROUND

  • 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.

    PMID: 15664172BACKGROUND

  • 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.

    PMID: 10859571BACKGROUND

  • 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.

    PMID: 15335344BACKGROUND

  • 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.

    PMID: 14979766BACKGROUND

  • 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.

    PMID: 24127165BACKGROUND

  • 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.

    PMID: 29236921BACKGROUND

  • 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.

    PMID: 28536500BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • James McPartland, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Wright, BS

CONTACT

203-785-3488n.wright@yale.edu

Adam Naples, PhD

CONTACT

203-785-2583adam.naples@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know whether they are receiving active or sham TMS until both sessions have been completed.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2021

First Posted

June 23, 2021

Study Start

March 17, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)