TMS for the Investigation of Brain Plasticity in Autism Spectrum Disorders

Completed

• Conditions: Intellectual Disability; Autism Spectrum Disorder
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT02836405
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Primary Completion: 2020-04
• Study Completion: 2020-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

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Exclusion Criteria

• Intracranial pathology, cerebral palsy, history of severe head injury, significant dysmorphology, or known intracranial lesion.
• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autism Spectrum Disorder (ASD)	Transcranial Magnetic Stimulation	Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
Healthy Control	Transcranial Magnetic Stimulation	Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.

Primary Outcome Measures

Name	Time	Method
Percent of baseline TMS-induced measures of human synaptic plasticity	120 minutes after cTBS	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.

Trial Locations

Locations (2)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States