Abstracts

Rationale: People experiencing generalized tonic-clonic seizures (GTCS) may benefit from continuous monitoring and early intervention, should a seizure occur. Given the diverse motor manifestations of seizures, the ability to characterize and quantify motor events, during a GTCS, would have a positive impact on epilepsy management. Currently there are no FDA-cleared devices outside of an epilepsy monitoring unit (EMU) that can reliably alert for GTCS and provide accurate information about semiology to their physicians. A device capable of reliable GTCS detection and recording with a low false positive rate is highly desirable for the outpatient management of people with epilepsy. Brain Sentinel™ has completed a prospective multi-center study validating the effectiveness of a novel surface electromyography (sEMG)-based GTCS detection system that can be worn without interfering with activities of daily living. Data captured with continuous sEMG monitoring might help patients with GTCS regain independence and provide clinically useful data for their epilepsy management.Methods: In this phase III double-blind controlled trial, we tested the ability of the Brain Sentinel™ system to detect GTCS as compared to vEEG detection in epilepsy monitoring units (EMU) at 11 NAEC level IV Epilepsy Centers in the United States. The Brain Sentinel™ system is capable of providing recorded sEMG and audio data continuously while it is worn on the biceps muscle. The sEMG data was processed in real-time by an algorithm previously validated in a single-site trial (Szabo et al., 2013). The classic GTCS semiology and timeline were independently adjudicated for all vEEG events recorded by a panel of ABPN certified epileptologists. The time of bilateral appendicular tonic motor manifestation of GTCS were compared to the Brain Sentinel™ system’s alarms to describe the device's characteristics.Results: To date, >7800 hours of sEMG and vEEG data have been reviewed in 136 subjects admitted to the EMUs. Interim analysis shows that when properly used the sensitivity to identify GTCS, as compared to vEEG review, is 100% CI [85 – 100], and false GTCS detection occurs at a rate of 0.05 per hour. The device was able to send an alert on average at 14 +/- 5 seconds after onset of GTCS. Neurologists may use this data to identify components of motor manifestation during GTCS or other times of interest reported by patients.Conclusions: The sensitivity of the Brain Sentinel™ system for detection of GTCS is comparable to epileptologists reviewing vEEG recordings. Final device performance will be presented for the full cohort (>180 subjects and 8000 hours of sEMG) at the conference. In addition to detecting GTCS, sEMG and audio is continuously recorded for retrospective review. Neurologists may use this data to identify components of motor manifestation during GTCS or other times of interest reported by a patient. Quantitative review of sEMG may be a useful tool for defining motor components of epileptic and nonepileptic motor recruitment during seizures. Funding was provided by Brain Sentinel™.