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

NCT02461459 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2024-10-26

No results posted yet for this study

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.

Conditions

  • Tuberous Sclerosis
  • Autism Disorder
  • Intellectual Disability

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Tuberous Sclerosis Alliance

    collaborator OTHER

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Office of Rare Diseases (ORD)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Darcy Krueger, MD, PhD · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02461459 on ClinicalTrials.gov