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Completed

NCT Number: NCT01361503

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital, Belmont, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Structural and neurochemical profiles of adolescents with ASD

    Time frame: scanning visit (1.5 hours)

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Mclean Hospital

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 26, 2011
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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