Early Biomarkers of Autism in Infants With Tuberous Sclerosis Complex (TSC)
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ClinicalTrials.gov Identifier: NCT01780441 |
Recruitment Status :
Completed
First Posted : January 31, 2013
Last Update Posted : February 4, 2021
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Tracking Information | |||||||
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First Submitted Date | January 28, 2013 | ||||||
First Posted Date | January 31, 2013 | ||||||
Last Update Posted Date | February 4, 2021 | ||||||
Actual Study Start Date | January 2013 | ||||||
Actual Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Early Biomarkers of Autism in Infants With Tuberous Sclerosis Complex (TSC) | ||||||
Official Title | Longitudinal Study to Identify Early Biomarkers of Autism Spectrum Disorder (ASD) in Infants With Tuberous Sclerosis Complex (TSC) | ||||||
Brief Summary | The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous sclerosis complex (TSC) for a new study on early markers of autism. The study is looking for early signs for autism in a population (TSC) where autism is common. The goal of this project is to use behavioral testing, MRI and EEG techniques to identify children at risk for developing autism starting at 3 months of age and continuing until 36 months of age. Throughout the study, the investigators will recommend Early Intervention services for any child who shows early signs of autism. | ||||||
Detailed Description | This is a five-year multi-site study using MRI and EEG technologies to identify developmental precursors of Autism Spectrum Disorder in patients with Tuberous Sclerosis Complex (TSC). The study will be enrolling infants at five TSC centers throughout the country, including Boston Children's Hospital, Cincinnati Children's Hospital Medical Center, University of Alabama at Birmingham, University of Texas at Houston and University of California Los Angeles. The main goal of this study is to identify early signs of autism in children with TSC looking at the brain through MRI/diffusion tensor imaging, EEG and behavioral/neuropsychological methods. Eligible infants between the ages of 3-12 months will be evaluated longitudinally at regular visit intervals up to 3 years of age. Study Objectives
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples With DNA Description: Blood
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Sampling Method | Non-Probability Sample | ||||||
Study Population | A total of 150 evaluable infants with TSC will be recruited. Diagnosis of TSC will be based on established clinical criteria and will not require genetic testing prior to participation. The target age of entry into study is 3-6 months, but infants up to age 12 months (less than or equal to 13.5 months) will be included. | ||||||
Condition | Tuberous Sclerosis Complex | ||||||
Intervention | Not Provided | ||||||
Study Groups/Cohorts | Tuberous Sclerosis Complex (TSC)
Tuberous Sclerosis Complex
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Publications * | Srivastava S, Prohl AK, Scherrer B, Kapur K, Krueger DA, Warfield SK, Sahin M; TACERN Study Group. Cerebellar volume as an imaging marker of development in infants with tuberous sclerosis complex. Neurology. 2018 Apr 24;90(17):e1493-e1500. doi: 10.1212/WNL.0000000000005352. Epub 2018 Mar 23. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
166 | ||||||
Original Estimated Enrollment |
150 | ||||||
Actual Study Completion Date | December 2020 | ||||||
Actual Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 3 Months to 12 Months (Child) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT01780441 | ||||||
Other Study ID Numbers | IRB-P00005074 1U01NS082320-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Mustafa Sahin, Boston Children's Hospital | ||||||
Study Sponsor | Boston Children's Hospital | ||||||
Collaborators |
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Investigators |
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PRS Account | Boston Children's Hospital | ||||||
Verification Date | February 2021 |