The Brain Sentinel-detecting seizures anywhere and anytime of the day and thereby granting peace of mind to those living with epilepsy.
The Brain Sentinel can detect seizures anywhere and anytime of the day and thereby grants peace of mind to those living with epilepsy and those who care for them. Read more about how this product works and who it can benefit.
What is the Brain Sentinel® Monitoring and Alerting System?
The Brain Sentinel® Monitoring and Alerting System is commercially known as the SPEAC® System (pronounced /spēk/). The SPEAC System is a non-EEG physiological signal-based seizure monitoring system: It is a non-invasive prescription device that records and analyzes surface-electromyography signals to identify those that may be associated with a generalized tonic-clonic (GTC) seizure.
Why is this seizure detection device useful?
GTC seizures are associated with a loss of consciousness. More than 50% of patients that experience them during sleep are unaware that they have occurred.1 Because GTC seizures are the number one risk factor for sudden unexpected Death in Epilepsy (SUDEP) it is important to have reliable methods for their detection and provide quantifiable data to neurologists to better manage them.2
Due to the similar qualitative description of events, psychogenic non-epileptic seizures (PNES) are often confused for epileptic seizures. It can take more than 5 years for a patient to be properly diagnosed with PNES.3 The SPEAC System provides quantifiable physiological signals that may triage patients with PNES and improve their time to proper diagnosis and treatment.
How does it work?
The SPEAC System operates by continuously analyzing single-channel surface-electromyography (sEMG) data.4, 5 The sEMG monitor attaches, via an adhesive electrode, to the belly of the biceps. The sEMG monitor is part of a system that records continuous sEMG data and transmits it to a remote location where the data can be further evaluated (with patient's medical history and subjective data) by a physician to classify events; e.g., GTC seizures, other motor seizures, and PNES.
How do you know that it is effective and accurate? Is it approved by the Food and Drug Administration (FDA)?
A multi-center, prospective, double-blind clinical study comparing Brain Sentinel's SPEAC System to video-electroencephalography (vEEG) found that the SPEAC System alarmed within an average of 5.3 seconds of upper extremities extension during GTC seizures in adults. In addition, results of this pivotal study comparing sEMG versus vEEG recordings showed that of the 24 GTC seizures identified by three independent epileptologists from vEEG data, the SPEAC System identified the same 24, resulting in a 100% positive agreement between the SPEAC System and the gold standard for seizure detection.5 On February 16, 2017, Brain Sentinel, Inc. received US Food and Drug Administration (FDA) de novo clearance to begin marketing. The SPEAC System is the first non-EEG, physiological, signal-based seizure monitoring system cleared by the FDA.
Which patients would benefit from using this device?
Patients that are suspected to have motor seizures would benefit from the quantitative data that is provided by this device. Subjective reports of seizure semiology are not the most reliable form of determining a person's commonly experienced seizure type or frequency.1, 6 Often physicians base treatment decisions on verbal reporting of seizures with little or no objective information. This is the first FDA cleared device that records physiological data for months at a time in the patient's home environment. This is important as the typical stressors that occur in a patient's home environment may not be present in a clinical setting.
How can someone obtain this device and what is the cost (is this covered by health insurance)?
Currently the SPEAC System is available to patients within the Veteran's Administration (VA) system. It is not yet covered by health insurance companies. We are conducting additional clinical and outcomes studies so that we will have the evidence base needed for payor coverage.
1. Hoppe C, Poepel A, Elger CE. Epilepsy: accuracy of patient seizure counts. Arch Neurol 2007;64:1595-1599.
2. DeGiorgio CM, Markovic D, Mazumder R, Moseley BD. Ranking the Leading Risk Factors for Sudden Unexpected Death in Epilepsy. Front Neurol 2017;8:1664-2295.
3. Salinsky M, Spencer D, Boudreau E, Ferguson F. Psychogenic nonepileptic seizures in US veterans. Neurology 2011;77:945-950.
4. Szabo CA, Morgan LC, Karkar KM, et al. Electromyography-based seizure detector: Preliminary results comparing a generalized tonic-clonic seizure detection algorithm to video-EEG recordings. Epilepsia 2015;56:1432-1437.
5. Halford JJ, Sperling MR, Nair DR, et al. Detection of generalized tonic-clonic seizures using surface electromyographic monitoring. Epilepsia 2017;58:1861-1869.
6. Blachut B, Hoppe C, Surges R, Elger C, Helmstaedter C. Subjective seizure counts by epilepsy clinical drug trial participants are not reliable. Epilepsy Behav 2017;67:122-127.
