Cognitive Neuroscience of Autism Spectrum Disorders

Sponsor
National Institute of Mental Health (NIMH) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT01031407
Collaborator
(none)
1,550
1

Study Details

Study Description

Brief Summary

Background:
  • Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison.

  • By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD.

Objectives:
  • To learn more about the brain in healthy people and in people with autism spectrum disorders.

  • To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants.

Eligibility:
The following groups of participants will be eligible for the study:
  • Individuals between 5 and 89 years of age who have autism spectrum disorders.

  • Healthy volunteers between 5 and 89 years of age.

  • Cognitively impaired children between 5 and 17 years of age.

  • Parents/caregivers/legal guardians of individuals in the above three groups.

Design:
  • Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant.

  • Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG).

  • The study will also collect blood or saliva to obtain a DNA sample.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objective: The primary objective of the proposed studies is to utilize neuroimaging (functional Magnetic Resonance Imaging [fMRI], structural MRI [sMRI], Magnetoencephalography [MEG]) and neuropsychological tools (eye-tracking, cognitive experiments, clinical neuropsychological measures, questionnaires, etc.) to identify cognitive idiosyncrasies (e.g., social-cognitive deficits, visual perceptual assets, and savant skills) characteristic of individuals on the autism spectrum and their neural underpinnings across childhood and adulthood.

    Study Population: Children, adolescents, and adults with autism spectrum disorders (ASDs), controls (i.e., typically developing children, adolescents, and adults and those with mild to moderate mental retardation), as well as caregivers/legal guardians/parents of these individuals.

    Design: Descriptive/Characterization/Observational studies using primarily neuropsychological and neuroimaging methodologies.

    Outcome Measures: Behavioral (reaction time, accuracy, eye movements, etc.) and neuroimaging (brain morphometry, BOLD, electrophysiology, etc.).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1550 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cognitive Neuroscience of Autism Spectrum Disorders
    Actual Study Start Date :
    Feb 21, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Healthy Volunteers

    Group 2

    Individuals with Autism Spectrum Disorders

    Group 3

    Parents of Healthy Volunteers, or Individuals with Autism Spectrum Disorders

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive and neurological phenotypes in ASD and control participants [Ongoing]

      Cognitive tasks and neuroimaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:
    Subjects will include:
    1. males and females.

    2. 5-89 years of age.

    3. A minimum IQ of 70

    Subjects in the ASD group will:
    1. meet DSM-IV criteria for one of the pervasive developmental disorders (i.e., autistic disorder, Asperger disorder, or pervasive developmental disorder-not otherwise specified).

    2. meet or pass the autism cut-off score for social symptoms on the ADI and/or the ASD cut-off score from social+communication symptoms on the ADOS.

    3. be able to provide their own consent (for adults).

    For inclusion in the facial recognition substudy, subjects must be:
    1. ages 18 to 35

    2. in good health

    3. with bad memory of faces

    EXCLUSION CRITERIA:
    All subjects, except for savants, also will be excluded if they have:
    1. a history of neurological insult/injury.

    2. substantial prenatal drug exposure known to affect later brain and behavior (e.g., cocaine, alcohol).

    3. severely premature birth or birth trauma.

    4. severe medical disorder (e.g., neurofibromatosis, hydrocephalus, cerebral palsy, uncontrollable seizure disorder).

    5. a known genetic disorder (e.g., Fragile X or Down syndrome) that would be expected to significantly impact findings from cognitive testing and/or neuroimaging.

    Furthermore, subjects will be excluded from MRI/MEG studies, if they have:
    1. any exclusion from MRI scanning including: the presence of metal in their body, having a pacemaker, and/or females who are pregnant.

    Healthy volunteers, except for parents of individuals with autism spectrum disorders and parents of healthy volunteers, will also be excluded if they have:

    1. a current or past history of axis I psychiatric conditions or any current usage of psychiatric medication.

    Savants have less restrictive exclusionary criteria because: 1) they are a very rare group, thus we don t want to limit recruitment further and 2) we can examine common and unique cognitive mechanisms across savants, a question of keen interest, regardless of co-morbidities. Those with tumors or other neuroimaging-relevant contraindications will be excluded from fMRI/MEG procedures.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Alex Martin, Ph.D., National Institute of Mental Health (NIMH)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Mental Health (NIMH)
    ClinicalTrials.gov Identifier:
    NCT01031407
    Other Study ID Numbers:
    • 100027
    • 10-M-0027
    First Posted:
    Dec 14, 2009
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Nov 23, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Mental Health (NIMH)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022