An observational study in Autism Spectrum Disorder and Intellectual Disability, sponsored by Boston Children's Hospital. Completed at 2 sites in United States. Open to participants aged 6 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Boston Children's Hospital · Observational
The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorder (ASD). Research suggests that during development, the brains of individuals with ASD may change in response to their experiences differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of ASD.
Autism Spectrum Disorders (ASD) are diagnosed clinically, based on key symptoms. As ASD phenotypic variability is large, and symptoms can manifest at different ages and degrees, the clinical diagnosis is challenging. To date, there remains an unmet need for a valid and reliable endophenotype that would facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and eventually serve as a useful biomarker to inform the development of effective therapies and assess treatment response in future clinical trials.
As compared with behavioral or neuroimaging methods, transcranial magnetic stimulation (TMS) offers the advantage of providing behaviorally independent results that are largely unaffected by attention or cognitive ability. Therefore, a TMS based endophenotype may be applicable to all individuals across the autism spectrum.
At Boston Children's Hospital, each subject's participation in the study will consist of four visits: two screening visits, and two TMS sessions. At Beth Israel Deaconess Medical Center, each subject's participation will consist of three visits: one screening visit, and two TMS sessions. Each screening visit is expected to last between 2-3 hours, during which participants will first provide informed consent. Participants will then receive a thorough medical examination by a neurologist, and a neuropsychological evaluation (including IQ measures and ASD specific evaluations). If eligible to continue, participants will then come back for two identical TMS visits, that are spaced 1-5 weeks apart. These visits are expected to last between 3-4 hours, and include the TMS measures of brain plasticity.
363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.
This study's enrollment of 164 is below the median of 200 across 114 observational studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children and adults diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
Inclusion Criteria at Boston Children's Hospital (children):
For ASD group:
Inclusion Criteria at Beth Israel Deaconess Medical Center (adults):
For ASD group:
Exclusion Criteria:
Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
Device: Transcranial Magnetic Stimulation
Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
Device: Transcranial Magnetic Stimulation
Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
Percent of baseline TMS-induced measures of human synaptic plasticity
Synaptic plasticity will be measured using the MEPs in response to cTBS. Baseline MEPs will be calculated before cTBS, and at different time points following cTBS up to 120 minutes. The investigators will compare post-cTBS MEPs to the baseline MEPs to calculate the percent change from baseline.
Time frame: 120 minutes after cTBS
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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