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Early Biomarkers of Autism in Infants with Tuberous Sclerosis Complex (TACERN)



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The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this study is to discover early signs of autism in children with tuberous sclerosis complex (TSC)—a population in which autism is common.  This 5-year, multi-site study will use various tests—including magnetic resonance imaging (MRI) and electroencephalogram (EEG)—to identify developmental precursors of autism spectrum disorders in children with TSC. 

A total of 150 infants will be enrolled at 5 TSC centers throughout the United States.  The main goal is to pinpoint early signs of autism by studying the brain using MRI, EEG, and behavioral/neuropsychological tests.  Eligible infants between the ages of 3-9 months will be evaluated at regular intervals over time until they reach 3 years of age.  Throughout the study, investigators will recommend intervention services for any child who shows signs of autism.

Duration of the study for participants is approximately 3 years.

Eligibility Criteria:

Inclusion:

  • Meets genetic or clinical diagnostic criteria for TSC, the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, echocardiogram.
  • Age criteria: 3 months - 9 months of age at time of enrollment (For study purposes, 3 months is defined as ≥ 9 weeks, 1 day and 9 months is defined as ≤ 10.5 months.)

Exclusion:

  • Prematurity, defined as gestational age < 37 weeks at time of delivery
  • Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment
  • Is taking an mTOR inhibitor such as rapamycin, sirolimus, or everolimus (other than topical formulations) at the time of study enrollment
  • Subependymal Giant Cell Astrocytoma requiring medical or surgical treatment
  • History of epilepsy surgery
  • Contraindications to MRI scanning, such as metal implants/non-compatible medical devices or medical conditions

Study Design: 

Observational, Longitudinal

Study Locations: 

Multiple U.S. locations

For more information:

Contact: info@tscstudy.com; or visit: http://clinicaltrials.gov/ct2/show/NCT01780441 or www.tscstudy.com

Last Reviewed February 13, 2014