TMS for the Investigation of Brain Plasticity in Autism Spectrum Disorders
NCT ID: NCT02836405
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
164 participants
OBSERVATIONAL
2015-05-31
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Autism Spectrum Disorder (ASD)
Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
Transcranial Magnetic Stimulation
Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
Healthy Control
Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
Transcranial Magnetic Stimulation
Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
Interventions
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Transcranial Magnetic Stimulation
Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
Eligibility Criteria
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Inclusion Criteria
1. Clinical diagnosis of a disorder on the autism spectrum.
2. Assessment using the Autism Diagnostic Observation Schedule.
3. Assessment using the Autism Diagnostic Interview-Revised.
4. Children ages 6-16.
5. IQ\>70.
6. Verbal.
* For ASD group:
1. Clinical diagnosis of a disorder on the autism spectrum.
2. Assessment using the Autism Diagnostic Observation Schedule.
3. Adults ages 21-65.
Exclusion Criteria
* History of fainting spells of unknown or undetermined etiology.
* History of head injury resulting in prolonged loss of consciousness.
* History of seizures, diagnosis of epilepsy, or immediate family history of epilepsy.
* Any progressive neurological disorder or signs of intracranial pressure.
* Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure.
* Metal implants or devices.
* Substance abuse or dependence within the past six months.
* Certain prescription medications that decrease cortical seizure threshold.
* Pregnancy.
6 Years
65 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
National Institute of Mental Health (NIMH)
NIH
Boston Children's Hospital
OTHER
Responsible Party
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Alexander Rotenberg
Associate Professor of Neurology
Principal Investigators
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Alexander Rotenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Alvaro Pascual-Leone, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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00014965
Identifier Type: -
Identifier Source: org_study_id