Cognitive Neuroscience of Autism Spectrum Disorders - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT01031407

Purpose

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
Autistic Disorder Asperger Syndrome Mental Retardation Child Adult

Study Type:	Observational
Official Title:	Cognitive Neuroscience of Autism Spectrum Disorders

Resource links provided by NLM:

Genetics Home Reference related topics: Asperger syndrome

MedlinePlus related topics: Asperger's Syndrome Autism MRI Scans

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	1400
Study Start Date:	November 2009

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. A secondary aim is to utilize the phenotypic data collected from these studies (and previous data collection) to identify subtypes that may inform genetic studies (both candidate gene and genome-wide scans) by linking these phenotypic data with genetic data.

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 as well as genetic techniques.

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

Eligibility

Ages Eligible for Study:	5 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

Subjects will include:

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

Subjects in the ASD group will:

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

a history of neurological insult/injury.
substantial prenatal drug exposure known to affect later brain and behavior (e.g., cocaine, alcohol).
severely premature birth or birth trauma.
severe medical disorder (e.g., neurofibromatosis, hydrocephalus, cerebral palsy, uncontrollable seizure disorder).
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:
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031407

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Adolphs R. The neurobiology of social cognition. Curr Opin Neurobiol. 2001 Apr;11(2):231-9. Review.

Alarcón M, Yonan AL, Gilliam TC, Cantor RM, Geschwind DH. Quantitative genome scan and Ordered-Subsets Analysis of autism endophenotypes support language QTLs. Mol Psychiatry. 2005 Aug;10(8):747-57.

Baharloo S, Johnston PA, Service SK, Gitschier J, Freimer NB. Absolute pitch: an approach for identification of genetic and nongenetic components. Am J Hum Genet. 1998 Feb;62(2):224-31.

ClinicalTrials.gov Identifier:	NCT01031407 History of Changes
Other Study ID Numbers:	100027, 10-M-0027
Study First Received:	December 11, 2009
Last Updated:	December 24, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Adolescents and Adults
Autism
Functional Magnetic Resonance Imaging (fMRI)
MEG
Structural MRI
HV

Autism Spectrum Disorder
ASD
Autistic Disorder
Asperger Syndrome
Mental Retardation
Healthy Volunteer

Additional relevant MeSH terms:

Autistic Disorder
Mental Retardation
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood

Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012