TABLE 1

Study Protocol and Design

TACERN study inclusion criteriaTSC-EBS study inclusion criteria
 Meets genetic or clinical diagnostic criteria for TSC on the basis of current recommendations for diagnostic evaluation, including physical examination, neuroimaging, and echocardiogram14 Meets genetic or clinical diagnostic criteria for TSC on the basis of current recommendations for diagnostic evaluation, including physical examination, neuroimaging, and echocardiogram14
 Age criteria: 3–12 mo at time of enrollment. For study purposes, 3 mo is defined as ≥9 wk, 1 d and 12 mo is defined as ≤13.5 mo. Age criteria: <6 mo at time of enrollment.
 Seizure free at the time of study enrollment
TACERN study exclusion criteriaTSC-EBS study exclusion criteria
 Gestational age <36 wk at time of delivery Gestational age <30 wk at time of delivery
 Taking an mTOR inhibitor such as rapamycin, sirolimus, or everolimus (other than topical formulations) at the time of study enrollment Taking vigabatrin or mTOR inhibitor before study enrollment
 Has taken an investigational drug as part of another research study within 30 d before study enrollment Participant’s neonatal course, time of delivery, or history includes CNS infection, hypoxic-ischemic encephalopathy, or intraventricular hemorrhage
 SEGA requiring medical or surgical treatment at the time of study enrollment History of seizures and/or infantile spasms
 History of epilepsy surgery at the time of study enrollment
 Contraindications to MRI scanning, such as metal implants and/or noncompatible medical devices or medical conditions
TACERN study visit agesTSC-EBS study visit ages
 3, 6, 9, 12, 18, 24, and 36 mo Before 3 wk, at 6 wk, and at 3, 4.5, 6, 9, 12, 18, and 24 mo
Information collected at baseline visit in both studies
 Demographics and medical history including seizures, medications, family history, physical and neurologic examinations, developmental assessment, and EEGs
Information collected at follow-up visits in both studies
 Seizures types and frequency, interval medical history, medications, physical and neurologic examinations, developmental assessment, EEGs, and results of yearly clinical brain MRI
TSC-EBS (P20NS080199 and NCT01767779)
TACERN (U01NS082320 and NCT01780441)
  • CNS, central nervous system; TACERN, TSC Autism Center of Excellence Research Network; TSC-EBS, Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC; —, not applicable.