PHILADELPHIA – The Brain Sentinel seizure detection system is nearly as sensitive as an epileptologist who reviews vEEG recordings, according to data presented at the 2015 American Epilepsy Society Annual Meeting in Philadelphia.
Results from the phase 3, double-blind controlled trial are the latest data supporting the device’s ability to detect and alert patients of generalized tonic-clonic seizure (GTCS), as well as collect vital data for review by a physician. The system, which collects continuous surface electromyopgraphy (sEMG) and audio data via a device strapped to the bicep, is currently under review by the FDA.
The current study evaluated the ability of the Brain Sentinel system to detect GTCS compared to vEEG detection in 11 epilepsy monitoring units in the U.S. Data for 136 participants was included.
Over 7800 hours of sEMG and vEEG data was reviewed for the 136 participants admitted to epilepsy monitoring units. Sensitivity to identify GTCS, when compared to vEEG review, was 100% CI (85-100), with false positive GTCS detection occurring at a rate of 1.4 false positives per 24 hours. The device was able to alert patients of GTCS an average of 14 +/- 5 seconds after onset.
“We hope that patients will be heard in a way that physicians have not heard them before,” Jose E. Cavazos, MD, PhD, told Neurology Advisor. “Having this objective data is critical.”
Dr. Cavazos also pointed out that the device is meant to not interfere with activities of daily living, and free patients of the stigma of epileptic seizure monitoring devices.
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- Cavazos JE, Girouard M, Halford J, et al. Abstract 3.088. Automated EMG based Seizure Detection and Quantification for the Home and the Epilepsy Monitoring Unit: A Prospective Multicenter Study. Presented at: American Epilepsy Society Annual Meeting; Dec. 4-8, 2015; Philadelphia.