Clinical trial NCT04936009: 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
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: right hemisphere N170 latency
timeFrame: Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours
measure: proportion of visual attention to the eye region of the face
timeFrame: Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: James McPartland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.