Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder (TMSinASD)
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring TMS
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.
- 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 exclude
Sites / Locations
- Yale University
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 lateralized N170 latency to upright faces
EEG brain response to faces as measured by the N170 component in milliseconds
Secondary Outcome Measures
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
The Benton Face Recognition Task
The total Benton score will be used to assess the ability to recognize and discriminate among faces
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04242355
Brief Title
Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder
Acronym
TMSinASD
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in Autism Spectrum Disorder (ASD). Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an EEG (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of TMS.
Detailed Description
Broad ranging social cognition difficulties are hallmark areas of impairment in autism spectrum disorder (ASD), and they are subserved by specific neural systems underpinning social perception and processing that are recognized to be atypical in ASD. Considering the neurodevelopmental nature of the disorder, and the recent findings regarding aberrant neuroplasticity in ASD, repetitive transcranial magnetic stimulation (rTMS) holds promise to directly modulate brain activity in these systems. The objective of this research proposal is to utilize a multimodal approach to provide a proof-of-concept for the ability of rTMS to (a) influence functioning in the brain systems involved in social ASD symptomatology and (b) modify associated social cognitive behaviors in adults with ASD. Toward achieving this objective, we propose to assess critical aspects of social cognition using the electroencephalogram (EEG), event-related potentials (ERPS), eye-tracking (ET), and behavioral tasks prior to and following a single rTMS session to provide preliminary insight into the potential of rTMS as a tool to modify social brain function in cognitively able adults with ASD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (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 lateralized N170 latency to upright faces
Description
EEG brain response to faces as measured by the N170 component in milliseconds
Time Frame
Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.
Secondary Outcome Measure Information:
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 for the duration of their visit, an expected average of 4-5 hrs.
Title
The Benton Face Recognition Task
Description
The total Benton score will be used to assess the ability to recognize and discriminate among faces
Time Frame
Measures will be recorded for the duration of their visit, an expected average of 4-5hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
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.
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 exclude
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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
background
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
background
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Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder
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