Diagnostic Utility of Continuous sEMG Monitoring in a Home Setting - Real-world use of the SPEAC® System (P4.5-012)

Objective: Report the diagnostic value of long-term, continuous, surface electromyography (sEMG) monitoring of patients for spell characterization in home setting. Background: 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 Generalized-Tonic Clonic (GTC) seizures, continuously record sEMG data for physicians to review other motor events, and provide an electronic seizure diary. Design/Methods: The system was used in home and/or hospital settings by 20 patients. 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 by their physician. Results: Patients wore the device for a total of 495 days (average 10.2 h/day). Three GTC seizures were detected. Two occurred in a patient that was wearing the device in an EMU and the third occurred in a patient using the system in a home setting. Neither patient was aware of the GTC seizures. Thirteen patients refused a threshold adjustment and were satisfied with a FAR of 0.5/24 h. Seven patients requested that the sensitivity be adjusted; resulting in a FAR of 0.3/24 h. Seventy percent of cases resulted in physicians reporting a change in their understanding of their patient’s seizures. This resulted in a change of ASM for 15 % of patients. Conclusions: Accurate information about seizure frequency, and type, would improve treatment decisions and patient outcomes. The SPEAC System provides information about motor seizures that was previously unavailable. Having objective information about seizures that occur outside of a clinical setting would improve patient care and would increase the value of trials of ASM. Disclosure: Dr. Whitmire has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Brain Sentinel. Dr. Voyles has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Brain Sentinel. Dr. Cardenas has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Brain Sentinel. Dr. Cavazos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Brain Sentinel. Dr. Cavazos holds stock and/or stock options in Brain Sentinel which sponsored research in which Dr. Cavazos was involved as an investigator. Dr. Cavazos holds stock and/or stock options in Brain Sentinel.