WASHINGTON — New data concluded that in addition to providing physicians with useful data, the Brain Sentinel Seizure Detection and Warning System identified generalized tonic-clonic seizures (GTCS) within 14 seconds of onset, as compared to their motor generalization onset by video electroencephalography (vEEG).
The study was presented at the 2015 American Academy of Neurology Annual Meeting in Washington, D.C.
“At the present time, we are practicing based on reports by our patients who often don’t realize when they have seizures,” José E. Cavazos, MD, PhD, co-founder of Brain Sentinel and study researcher, said in an interview. “This information gap might be closed and revolutionized by our device, which provides electromyography [EMG] waveform data of seizures in patients with epilepsy.”
Cavazos and colleagues conducted the phase III, prospective, double-blind controlled clinical trial to determine the efficacy of the Brain Sentinel GTCS detection system vs. the gold standard of vEEG detection. The Brain Sentinel system continuously records EMG data for post-hoc analysis of all motor events, as well as identifies and archives motor activity during GTCS.
According to Cavazos, the EMG device used in the study is discreet and easy to wear, weighing only 6.5 ounces.
“It fits on the belly of the biceps, where it is relatively comfortable and unobtrusive,” he said. “It also has an alarm that detects a seizure in real time and then alerts a caregiver who can provide help in a quick amount of time.”
For the study, epilepsy monitoring units from 11 National Association of Epilepsy Centers Level IV Epilepsy Centers participated and 171 patients (62% women) with epilepsy were enrolled, equating to more than 7,800 hours of simultaneous EMG and vEEG data.
Results indicated that the detection device was able to identify GTCS within a mean of 14 seconds of vEEG diagnosis, with a 100% positive agreement (95% CI, 85-100) of vEEG monitoring among patients with proper placement of the device. The EMG recording was also found to be a useful modality for neurologists in the evaluation of motor manifestations arising from GTCS activity or other motor-related events, according to results.
“This device is something that can potentially give patients with epilepsy a voice to be heard when they are having seizures,” Cavazos said. “It also provides better epilepsy management and therefore gives patients better control.”
- Cavazos JE et al. Abstract I6-4B. Presented at: American Academy of Neurology Annual Meeting 2015; April 18-25, 2015; Washington, D.C.