Sensory and Connectivity Abnormalities in Autism Spectrum Disorders

MEG/EEG/MRI and Psychophysics Study of Developmental Disorders

Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder

Detailed Description

(NOTE: we are currently recruiting individuals between the ages of 14 and 32, either typically developing or with an autism spectrum disorder.)

To study how sensory information is processed by the brain, we primarily use an instrument called MEG (MagnetoEncephaloGraphy), which measures the magnetic brainwaves emitted by our brains. The device does not have any output (i.e., there is no magnetic field); it only measures the waves produced in the brain.

We measure those waves as the participants in the study listen to, view, or otherwise experience simple, non painful, stimuli. For instance, participants may listen to words while sitting in the MEG room, and watching a movie with the sound turned off.

We then combine this information with pictures of the brain from MRI (Magnetic Resonance Imaging - when available), to get an idea about both the anatomy and the function of the brain, so that we can study how the brains of populations with autism spectrum disorders or language disorders may be different from those of typically developing populations.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Nicole McGuiggan, Rsch Coord; Phone Number: 617-966-9766; Email: TRANSCEND@partners.org

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Martinos Center or Biomedical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 32 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult/Pediatric

Description

Inclusion Criteria:

• All of the following criteria must be met by all participants:

  • The participant or the participant's legal guardian is able to understand and is willing to comply with the requirements of the study
  • The participant meets the age requirements (14-32 years old)
  • The participant or legal guardian has signed an Informed Consent Form specific to this study, and is able to understand the consent form.
  • The participant must have English as their first language.
  • The participant must have a non-verbal IQ > 70

• For the ASD/language disorder group only:

  • Autism Spectrum Disorder: Participants must meet criteria for Autism Spectrum Disorder on the ADOS.

Exclusion Criteria:

• The following exclusion criteria apply to both control and autism groups:

  • Any volunteer for whom informed consent cannot be obtained
  • Volunteers with metal braces, extensive dental work involving metals, implanted electromagnetically activated medical equipment (cardiac pacemakers, neurostimulators, functioning infusion pumps), all of which would interfere with the MEG signal, will be excluded from the MEG portion of the study
  • Volunteers with any medically diagnosed sensory loss
  • Volunteers with a known genetic disorder (e.g. Tourette's syndrome, etc), or other medical condition affecting the brain, such as progressive encephalopathy as well as those who are on high doses of multiple anti-seizure medications and have frequent, uncontrolled seizures
  • Asphyxia at birth or any other time, premature birth (Fewer than 34 weeks gestation)

• For the control group only:

  • Volunteers diagnosed with a mental condition such as depression, anxiety, aggression, hyperactivity, attention deficit disorder (with or without hyperactivity).
  • Volunteers who score below the autism spectrum cut-off (in the normal range) on the ADOS and SCQ
  • Volunteers on any sort of neuro-psychopharmacological treatment (including antidepressants, stimulants, antipsychotics, anticonvulsants, benzodiazepines).

• For the autism group only:

  • Children or adults not meeting criteria for autism spectrum disorder
  • Volunteers with co-morbid disorders such as tuberous sclerosis or fragile X.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy individuals; No intervention Healthy participants ages 14-32 for a neuroimaging study
Individuals with Autism Spectrum Disorder; No intervention ASD participants ages 14-32 for a neuroimaging study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Saliency of Sensory Stimuli in Developmental Disorders	up to 2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Tal Kenet, Ph.D, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: October 23, 2007
• First Submitted That Met QC Criteria: August 10, 2009
• First Posted (Estimate): August 11, 2009

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: MRI; autism; language; brain; MEG; autistic; sensory; connectivity; developmental; neurodevelopmental; aspergers; asperger's; coherence
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 2005P001768; 5R01MH117998 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No