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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in ADOS-2 scores at end of study
Timeframe: 24 months
Change in SBIS-5 scores or Mullen Scales of Early Learning (MSEL) at end of study
Timeframe: 24 months
Change in Fractional anisotropy (FA) at 12 months
Timeframe: 12 months
Change in fractional anisotropy (FA) at 24 months
Timeframe: 24 months
Change in radial diffusivity (RD) at 12 months
Timeframe: 12 months
Change in radial diffusivity (RD) at 24 months
Timeframe: 24 months
Change in mean diffusivity (MD) of cerebellar fascicles at 12 months
Timeframe: 12 months
Change in mean diffusivity (MD) of cerebellar fascicles at 24 months
Timeframe: 24 months
Change in axial diffusivity (AD) at 12 months
Timeframe: 12 months
Change in axial diffusivity (AD) at 24 months
Timeframe: 24 months