Brain Genomics Superstruct Project

Autism Spectrum Disorders Clinical Trial

Official title:

Brain Genomics Superstruct Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552460
• Other study ID #: 2011P000375
• Status: Completed
• Start date: April 2011
• Est. completion date: January 2015

Study information

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

Clinical Trial Summary

The purpose of this study is to explore the effects of genes and genetic variation on brain structure and function. Investigators at Harvard plan to explore the relationship between candidate genes that affect cognitive performance and brain structure/function. Since brain phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show greater sensitivity than cognitive performance to measure gene effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

1. 13 years or older

2. Subject must have a current DSM-IV diagnosis of high functioning ASD, based on past evaluations at the Bressler Clinic.

3. Subjects 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.

4. Each subject must understand the nature of the study. The subject must sign an IRB approved informed consent.

Exclusion Criteria:

1. IQ < 70 bassed on evaluation in the Bressler Clinic.

2. Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).

3. Neuropsychiatric conditions (such as dementia) which sufficiently impair cognition such that a surrogate consent would be required.

4. Neurological disorders associated with gross brain pathology (other than atrophy), e.g., stroke, tumors, or demyelinating diseases.

5. Pregnancy.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroimaging phenotype		1 day