Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)

Status: Active_not_recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

The purpose of this study is to characterize the developmental phenotype of ASD and ID and to identify biomarkers using advanced MRI methodology and electrophysiological biomarkers of synaptic function and connectivity predictive of ASD and ID presence and severity in patients with TSC. In addition, this study will be establishing infrastructure for the collection and storage of human bio-specimens, including genetic material, from TSC patients and their family members with ASD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: t
View:

• Meets genetic or clinical diagnostic criteria for TSC (Tuberous Sclerosis), the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, and echocardiogram.

• Age criteria: over 18 months of age at time of enrollment.

• Is diagnosed or suspected to have ASD and/or ID.

• Primary communicative language is English

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
University of California at Los Angeles
Los Angeles
Stanford University
Palo Alto
Massachusetts
Boston Children's Hospital
Boston
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Texas
University of Texas at Houston
Houston
Time Frame
Start Date: 2015-05
Completion Date: 2026-12
Participants
Target number of participants: 205
Treatments
Tuberous Sclerosis Complex
Tuberous Sclerosis Complex
Sponsors
Collaborators: Tuberous Sclerosis Alliance, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Office of Rare Diseases (ORD), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov