NCT02836405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

4.9 years

First QC Date

May 13, 2016

Last Update Submit

December 3, 2020

Conditions

Autism Spectrum DisorderIntellectual Disability

Keywords

AutismASDAutistic DisorderPervasive Development DisordersPervasive Child Development DisordersAsperger's SyndromeTranscranial Magnetic StimulationTMSAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Autism Spectrum Disorder (ASD)

Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.

Device: Transcranial Magnetic Stimulation

Healthy Control

Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.

Autism Spectrum Disorder (ASD)Healthy Control

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children and adults diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.

You may qualify if:

  • For ASD group:
  • Clinical diagnosis of a disorder on the autism spectrum.
  • Assessment using the Autism Diagnostic Observation Schedule.
  • Assessment using the Autism Diagnostic Interview-Revised.
  • Children ages 6-16.
  • IQ\>70.
  • Verbal.
  • For ASD group:
  • Clinical diagnosis of a disorder on the autism spectrum.
  • Assessment using the Autism Diagnostic Observation Schedule.
  • Adults ages 21-65.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sample for genetic testing (optional)

MeSH Terms

Conditions

Autism Spectrum DisorderIntellectual DisabilityAutistic DisorderChild Development Disorders, PervasiveAsperger Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Alexander Rotenberg, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Alvaro Pascual-Leone, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

May 13, 2016

First Posted

July 19, 2016

Study Start

May 1, 2015

Primary Completion

April 1, 2020

Study Completion

July 1, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)