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

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361503
• Other study ID #: 2010-P-000185
• Status: Completed
• Start date: April 2010
• Est. completion date: September 2014

Study information

• Verified date: July 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural and neurochemical profiles of adolescents with ASD	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.	scanning visit (1.5 hours)