Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Neuroscience of Autism Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT01031407
First received: December 11, 2009
Last updated: November 11, 2014
Last verified: May 2014

December 11, 2009
November 11, 2014
November 2009
Not Provided
Group differences in brain structure, brain function, and cognitive functions, as well as their genetic associations.
Not Provided
Complete list of historical versions of study NCT01031407 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Neuroscience of Autism Spectrum Disorders
Cognitive Neuroscience of Autism Spectrum Disorders

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.

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.).

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Autistic Disorder
  • Asperger Syndrome
  • Mental Retardation
  • Child
  • Adult
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
Not Provided
Not Provided
  • INCLUSION CRITERIA:

Subjects will include:

  1. males and females.
  2. 5-89 years of age.
  3. A minimum IQ of 70 if age 18 or older.
  4. A minimum IQ of 50 if ages 5-17.

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.

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:

  6. 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, parents of healthy volunteers, and parents of children with cognitive impairments, 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. Those with tumors or other neuroimaging-relevant contraindications will be excluded from fMRI/MEG procedures.

Both
5 Years to 89 Years
Yes
Contact: Bako A Orionzi (301) 435-4928 bako.orionzi@nih.gov
Contact: Alex Martin, Ph.D. (301) 435-1926 alexmartin@mail.nih.gov
United States
 
NCT01031407
100027, 10-M-0027
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Alex Martin, Ph.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP