Clinical trial · Observational
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autism Disorder | — | UNRESOLVED | — |
| Intellectual Disability | — | UNRESOLVED | — |
| Tuberous Sclerosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Tuberous Sclerosis Complex
- description
- Tuberous Sclerosis Complex
Primary outcomes (10)
- measure
- Change in ADOS-2 scores at end of study
- timeFrame
- 24 months
- description
- Using standardized composite score for ADOS-2 performed yearly to determine ASD
- measure
- Change in SBIS-5 scores or Mullen Scales of Early Learning (MSEL) at end of study
- timeFrame
- 24 months
- description
- Using standardized IQ score from the Stanford-Binet Intelligence Scales Fifth Edition (SBIS-5) or Mullen Scales of Early Learning (MSEL) performed yearly to determine ID
- measure
- Change in Fractional anisotropy (FA) at 12 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment. * For subjects involved in imaging biomarker assessment: contraindications to 3T MRI scanning, such as metal implants/non-compatible medical devices or medical conditions, including vagus nerve stimulator. * For subjects involved in EEG/ERP biomarker assessment: contraindications to EEG/ERP, such as uncooperative or destructive behaviors preventing lead placement or capture by ERP/VEP equipment. Under age 2 or above age 11 at the time of enrollment. * Unwilling or unable to comply with study procedures and assessments.
References
Publications (0)
Data not yet available