Published: July 31, 2026
Norton Children’s Neuroscience Institute, affiliated with UofL School of Medicine, is one of only three sites in the United States selected to participate in the TETRIS study, a clinical trial examining how remote patient monitoring can help clinicians better optimize treatment in patients diagnosed with some severe types of epilepsy.
The TETRIS clinical trial enrolls patients with Dravet syndrome and Lennox-Gastaut syndrome (LGS), two rare and often refractory epilepsy syndromes.Dravet syndrome typically presents in infancy with frequent, prolonged seizures, and LGS is characterized by multiple seizure types with a high rate of medication failure. Fenfluramine is one of the few Food and Drug Administration-approved options for both conditions, but achieving optimal dosing remains difficult given the variability of seizure patterns across patients. This trial is designed to address that challenge by equipping patients with continuous home monitoring between clinical visits.Eligible patients, ages 3 and up, complete several home monitoring periods, each lasting three to seven consecutive days, with duration determined by the treating physician based on seizure type and frequency.Patients use a Byteflies device, a portable, medically certified wearable device that captures real-world physiologic data including:
The primary endpoint evaluates physician confidence in treatment decision-making, comparing clinician-rated confidence with and without remote patient monitoring (RPM) data using a standardized scale. The study defines success as improved confidence in at least 50% of cases when RPM data is available.
Norton Children’s selection reflects its standing in both pediatric epilepsy care and clinical research infrastructure.
“Unlike trials involving experimental therapies, the noninvasive wearable design and home-based monitoring can reduce participation barriers for families managing complex care needs,” said Dylan C. Brock, M.D., pediatric neurologist with Norton Children’s Neuroscience Institute, who serves as principal investigator. “Meanwhile, the at-home device will generate data that can more accurately reflect real-world seizure burden outside of the monitored clinic setting.”
Pediatric epilepsy neurologist Jaime A. Shoup, M.D., also with Norton Children’s Neuroscience Institute, serves as subinvestigator. The site enrollment goal is three to six patients. No other regional centers were chosen.
Drs. Brock and Shoup both serve as assistant professors with the University of Louisville School of Medicine Division of Neurodevelopmental Science.