TABLE 1.

Study Protocol and Design

TACERN study inclusion criteria	TSC-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 criteria	TSC-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 ages	TSC-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.