Magnetic Resonance Spectroscopic and Diffusion Tensor Imaging of Adolescents With Autism Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01361503
First received: November 19, 2010
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20 children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison, MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20 subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered a detailed assessment battery consisting of cognitive assessments (neuropsychological battery including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean Hospital (approximately 1.5 hours).

The investigators hypothesize that youth with ASD versus controls will exhibit increased glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize that compared to neurotypical controls, the structural integrity of white mater tracts will be disrupted in ASD.


Condition
Autism Spectrum Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Magnetic Resonance Spectroscopic and Diffusion Tensor Imaging of Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Structural and neurochemical profiles of adolescents with ASD [ Time Frame: scanning visit (1.5 hours) ] [ Designated as safety issue: No ]
    Concentrations of various neurochemicals, including glutamate, will be examined in addition to the structural integrity of white matter tracts. These results will be compared to results from control subjects.


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Autism Spectrum Disorder (ASD)
Controls

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from current patients of The Alan and Lorraine Bressler Clinic for Autism Spectrum Disorders. We propose to contact by letter (via regular mail or email) or telephone patients who have been identified by clinicians as expressing interest in the study. Subjects who have participated in previous protocols in our program may also be eligible to participate in this study. We propose to contact by letter or telephone past study participants who have expressed interested in being contacted about future studies they may be eligible for in our office. If a potential subject's clinician ascertains that the patient has an interest in study participation, the clinician will only offer contact information for the study to the patient and/or the patient's parents. The patient and/or parent can then contact the study coordinator for more information on the actual study.

Criteria

Inclusion Criteria

  • Male or female participants between 6 and 17 years of age.
  • Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria for autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical interview.
  • Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
  • Subjects and their legal representative must be considered reliable reporters.
  • Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative and the subject must sign an IRB approved informed consent and assent document respectively.
  • Participants with disruptive behavior disorders, mood and anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria

  • IQ < 85.
  • DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.
  • Current diagnosis of a psychotic disorder or unstable bipolar disorder.
  • History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.
  • History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse.
  • Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others.
  • Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
  • Organic brain disorders.
  • History of non-febrile seizures without a clear and resolved etiology in last 1 month.
  • Pregnant or nursing females.
  • Left hand dominant subjects.
  • History of claustrophobia or fear of enclosed places.
  • Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items).
  • Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361503

Contacts
Contact: Katie McDermott, BS 617-726-4651 kmmcdermott@partners.org

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: David Crowley       djcrowley@mclean.harvard.edu   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katie McDermott, BS    617-726-4651    kmmcdermott@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Mclean Hospital
Investigators
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gagan Joshi, MD, Instructor in Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01361503     History of Changes
Other Study ID Numbers: 2010-P-000185
Study First Received: November 19, 2010
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorders
Asperger's Syndrome
Adolescents
Magnetic Resonance Spectroscopy
Diffusion Tensor Imaging

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014