Abstracts

Rationale: A quality measure in epilepsy is to record the frequency of seizures at each visit. Outside of a clinical setting, seizure frequency is a patient-reported outcome. Objective seizure data would improve patient care and the assessment of future anti-seizure medications (ASM). The SPEAC® System is designed to alarm for GTC seizures, continuously record sEMG data for physicians to review other motor events, and provide an electronic seizure diary. This study demonstrates the diagnostic value of long-term, continuous, sEMG monitoring for patients with questionable spell characterization in a home setting. Methods: The system was prospectively used by patients in one of two scenarios: 1) home only or 2) hospital transitioning to a home setting for 30-day increments. Automated GTC seizure detection sensitivity and false alarm rates (FAR) were calculated based on patient reported outcomes and physician review of collected data. Patients were able to have alarm thresholds adjusted with guidance from their physician. In the home setting patients are shipped the System, remotely trained on its use, and are contacted (at least weekly) via phone and/or text to provide an opportunity for technical assistance and verify monitoring results. Neurologists, ABPN certified in epilepsy, reviewed sEMG data and provided impressions of each study. Ordering physicians were asked to complete a survey about diagnostic and treatment outcomes following use of the system. (As of abstract submission, the cohort includes 48 patients; more will be included and evaluated by the meeting.) Results: Forty-three patients wore the device in a home setting only for a total of 1,577 days (average 8.8 h/day), and five wore the device in a hospital transitioning to a home environment for a total of 81 days (average 12.7 h/day). The average patient age was 40 (range 14 – 70).Nine GTC seizures were confirmed by review of sEMG data and audio that were captured by the system. Two were experienced by a patient in an EMU, seven were detected across three patients that used the system in a home setting. Only one of these patients were aware that a seizure had occurred. (Panel A and B show recordings of a representative GTC seizures.) Twenty-six patients used the SPEAC System’s push-button feature to mark a total of 129 events for review. None of these were evaluated as GTC seizures. There were several other types of positive motor events that were captured with routine monitoring. Examples are shown in Panels C and D that were thought by the ordering physicians to be focal with unilateral muscle contraction (C), and hyperkinetic (D) in nature.Forty-two percent of physician surveys stated that use of the SPEAC System changed their understanding of their patient’s seizure events (13/31 responders). Twenty-seven percent of physician surveys indicated that use of the SPEAC System resulted in a change in their patient’s plan of care (8/30 responders). Conclusions: The ability to capture objective data about seizure frequency and type, over long periods of time, would improve treatment decisions and patient outcomes. The SPEAC System provides information about motor seizures that was previously unavailable in a patient’s native environment. Information provided from SPEAC monitoring result in physicians having a better understanding of their patient’s events and with clinical correlation assists in making treatment decisions. Funding: This study was funded by Brain Sentinel Inc.