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

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Magnetic Stimulation (TMS)

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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.
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.

Sites / Locations

Yale University Child Study CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Transcranial Magnetic Stimulation - real

Transcranial Magnetic Stimulation - sham

Arm Description

Participants will receive active TMS during their study visit

Participants will receive sham stimulation during their study visit simulating TMS

Outcomes

Primary Outcome Measures

right hemisphere N170 latency

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04936009

First Posted

June 13, 2021

Last Updated

April 6, 2023

Sponsor

Yale University

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04936009

Brief Title

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

Official Title

Noninvasive Brain Stimulation to Treat Core Social Deficits in Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 17, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transcranial Magnetic Stimulation - real

Arm Type

Active Comparator

Arm Description

Participants will receive active TMS during their study visit

Arm Title

Transcranial Magnetic Stimulation - sham

Arm Type

Placebo Comparator

Arm Description

Participants will receive sham stimulation during their study visit simulating TMS

Intervention Type

Behavioral

Intervention Name(s)

Transcranial Magnetic Stimulation (TMS)

Intervention Description

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

Primary Outcome Measure Information:

Title

right hemisphere N170 latency

Description

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

Time Frame

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

Title

proportion of visual attention to the eye region of the face

Description

visual attention to the eye region of the face as measured by eye tracking in seconds

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicole Wright, BS

Phone

203-785-3488

n.wright@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Adam Naples, PhD

Phone

203-785-2583

adam.naples@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James McPartland, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University Child Study Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Wright

Phone

860-785-3488

n.wright@yale.edu

First Name & Middle Initial & Last Name & Degree

Adam Naples, PhD

First Name & Middle Initial & Last Name & Degree

James McPartland, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19833552

Citation

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.

Results Reference

background

PubMed Identifier

15664172

Citation

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.

Results Reference

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PubMed Identifier

10859571

Citation

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.

Results Reference

background

PubMed Identifier

15335344

Citation

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.

Results Reference

background

PubMed Identifier

14979766

Citation

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.

Results Reference

background

PubMed Identifier

24127165

Citation

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.

Results Reference

background

PubMed Identifier

29236921

Citation

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.

Results Reference

background

PubMed Identifier

28536500

Citation

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.

Results Reference

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

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