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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936009
• Other study ID #: 2000030576
• Secondary ID: Proposal No. AR2
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Nicole Wright, BS
• Phone: 203-785-3488
• Email: n.wright[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Transcranial Magnetic Stimulation (TMS)
Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions

Locations

Country	Name	City	State
United States	Yale University Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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