Abstracts

Rationale: The Brain Sentinel® Monitoring and Alerting System is an FDA cleared device designed to alert caregivers of a potential Generalized Tonic-Clonic Seizures (GTCS) using surface electromyography (sEMG). The system also records and stores sEMG data for subsequent review by a trained healthcare professionals. The ability of trained physicians to interpret the sEMG data collected on this device must be evaluated. Methods: A prospective, multicenter, phase III, double-blinded trial of the seizure monitor device resulted in 100% sensitivity for detection of 29 GTCS, with a false alarm rate of 1.44/day while the device was worn properly over the belly of the biceps and without customizing the sensitivity to the individual (Halford et al. 2017). These GTCS have been evaluated in post processing for their frequency and amplitude characteristics using the wavelet transform technique, with the intention of improving the interpretation of the collected data. Using data recorded from this pivotal regulatory study, three board certified epileptologists identified 11 motor psychogenic non-epileptic spells (PNES) while patients were wearing the device. These events were evaluated in post processing exactly like the GTCS as described above. Several independent epileptologists have been asked to interpret the raw sEMG and post processed wavelet-transformed data for a diagnostic classification of the event. Epileptologists received training with a set of 9 different events (3 of each GTCS, PNES, and false alarms). After training, epileptologists were immediately provided with 24 epochs of 2 minute events including 8 GTCS, 8 PNES, and 8 false alarms that were presented in a random sequence with no additional information. Results: To date, two ABPN certified epileptologist have completed the classification exercise. The results showed an average of 6.5/8 events correctly classified as GTCS events, and 16/16 non-GTCS epochs were correctly not classified as GTCS. The average time for the classification exercise of 24 epochs was 28 minutes. At the annual meeting, we intend to present the results of cohort of our 15 epileptologists in our pivotal regulatory trial. Conclusions: The Brain Sentinel® Monitoring and Alarming System provides sEMG and post processing analyses that seem sufficient for screening of sEMG events for classification into GTCS and accurate for rejection of non-GTCS events. Funding: Brain Sentinel funded this pivotal regulatory study that led to FDA clearance for the Brain Sentinel® Monitoring and Alarming System.