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TMS for the Investigation of Brain Plasticity in Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT02836405
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alexander Rotenberg, Boston Children's Hospital

Tracking Information
First Submitted Date May 13, 2016
First Posted Date July 19, 2016
Last Update Posted Date December 4, 2020
Study Start Date May 2015
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2016)
Percent of baseline TMS-induced measures of human synaptic plasticity [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TMS for the Investigation of Brain Plasticity in Autism Spectrum Disorders
Official Title Investigations of Neuroplasticity Mechanisms in Autism Spectrum Disorders
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva sample for genetic testing (optional)
Sampling Method Non-Probability Sample
Study Population Children and adults diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
Condition
  • Autism Spectrum Disorder
  • Intellectual Disability
Intervention Device: Transcranial Magnetic Stimulation
Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
Study Groups/Cohorts
  • Autism Spectrum Disorder (ASD)
    Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
    Intervention: Device: Transcranial Magnetic Stimulation
  • Healthy Control
    Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.
    Intervention: Device: Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 3, 2020)
164
Original Estimated Enrollment
 (submitted: July 18, 2016)
37
Actual Study Completion Date July 2020
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria at Boston Children's Hospital (children):

  • For ASD group:

    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.

Inclusion Criteria at Beth Israel Deaconess Medical Center (adults):

  • 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:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02836405
Other Study ID Numbers 00014965
1R01MH100186-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Alexander Rotenberg, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators
  • Beth Israel Deaconess Medical Center
  • National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Alexander Rotenberg, MD, PhD Boston Children's Hospital
Principal Investigator: Alvaro Pascual-Leone, MD, PhD Beth Israel Deaconess Medical Center
PRS Account Boston Children's Hospital
Verification Date December 2020