NCT01552460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

3.8 years

First QC Date

March 1, 2012

Last Update Submit

June 27, 2024

Conditions

Keywords

Autism Spectrum DisordersBrain ImagingGenetics

Outcome Measures

Primary Outcomes (1)

  • Neuroimaging phenotype

    1 day

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with Autism Spectrum Disorders ages 13 and older.

You may qualify if:

  • years or older
  • Subject must have a current DSM-IV diagnosis of high functioning ASD, based on past evaluations at the Bressler Clinic.
  • 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.
  • Each subject must understand the nature of the study. The subject must sign an IRB approved informed consent.

You may not qualify if:

  • IQ \< 70 bassed on evaluation in the Bressler Clinic.
  • Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
  • Neuropsychiatric conditions (such as dementia) which sufficiently impair cognition such that a surrogate consent would be required.
  • Neurological disorders associated with gross brain pathology (other than atrophy), e.g., stroke, tumors, or demyelinating diseases.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Gagan Joshi, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 13, 2012

Study Start

April 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations