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Cognitive Neuroscience of Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01031407
Recruitment Status : Recruiting
First Posted : December 14, 2009
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date December 11, 2009
First Posted Date December 14, 2009
Last Update Posted Date September 25, 2019
Actual Study Start Date February 21, 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: May 23, 2013)
Group differences in brain structure, brain function, and cognitive functions, as well as their genetic associations.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01031407 on ClinicalTrials.gov Archive Site
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 Cognitive Neuroscience of Autism Spectrum Disorders
Official Title Cognitive Neuroscience of Autism Spectrum Disorders
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.
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 Type Observational
Study Design Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Asperger's Disorder
  • Mental Retardation
  • Children
  • Adult
  • Autism Spectrum Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 21, 2019)
1550
Original Estimated Enrollment
 (submitted: December 11, 2009)
1400
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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:

  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 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 89 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kelsey D Csumitta (301) 435-4928 kelsey.csumitta@nih.gov
Contact: Alex Martin, Ph.D. (301) 435-1926 alexmartin@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01031407
Other Study ID Numbers 100027
10-M-0027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators
Principal Investigator: Alex Martin, Ph.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 20, 2019