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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH100186-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorder (ASD) | Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity. |
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| Healthy Control | Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 120 minutes after cTBS |
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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:
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Children and adults diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Rotenberg, MD, PhD | Boston Children's Hospital | Principal Investigator |
| Alvaro Pascual-Leone, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D008607 | Intellectual Disability |
| D001321 | Autistic Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D020817 | Asperger Syndrome |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Saliva sample for genetic testing (optional)
| Boston |
| Massachusetts |
| 02215 |
| United States |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |