Transcranial Magnetic Stimulation (TMS) Study for Adults With Autism Spectrum Disorder (ASD)
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transcranial Magnetic Stimulation - real Participants will receive active TMS during their study visit |
Behavioral: Transcranial Magnetic Stimulation (TMS)
Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions
|
| Placebo Comparator: Transcranial Magnetic Stimulation - sham Participants will receive sham stimulation during their study visit simulating TMS |
Behavioral: Transcranial Magnetic Stimulation (TMS)
Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions
|
Outcome Measures
Primary Outcome Measures
- right hemisphere N170 latency [Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours]
EEG brain response to faces as measured by the N170 component in milliseconds
- proportion of visual attention to the eye region of the face [Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours]
visual attention to the eye region of the face as measured by eye tracking in seconds
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder.
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Individuals able to participate in an EEG and eye-tracking experiment.
Exclusion Criteria:
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Participants reporting significant head trauma or serious brain illness.
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Participants with major psychiatric illness that would preclude completion of study measures.
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Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of seizures.
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Participants taking prescription medications that may affect cognitive processes under study.
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Participants who have taken alcohol or recreational drugs within the preceding 24 hours.
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Females of known/suspected pregnancy or who test positive on a pregnancy test.
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Participants with a history of metalworking or injury by shrapnel or metallic objects are also excluded.
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Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit.
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Participants with an IQ (intelligence quotient) below 80.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University Child Study Center | New Haven | Connecticut | United States | 06520 |
Sponsors and Collaborators
- Yale University
- United States Department of Defense
Investigators
- Principal Investigator: James McPartland, PhD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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. Review.
- 2000030576
- Proposal No. AR200174