Our Story – It’s Personal
Our story started with a young boy, the grandson of healthcare visionary. Doctors could not understand why or how he suddenly developed seizures. The family searched for answers. They found none. His mother spent many anxious nights watching her son sleep hoping to find clues or answers in the next seizure. None came. Countless hours, both day and night, were spent at facilities waiting for answers to be discovered. There were none. The family tried the seizure detection technologies available without success. None helped. There were no answers, no relief, no control.
Ultimately, the grandfather decided if there was going to be help in this area for physicians, patients, and parents—families struggling just like his, it was going to have to be created. In collaboration with Mike Girouard, our President, and Dr. José E. Cavazos, M.D., PhD, a renowned Epileptologist, they founded Brain Sentinel in 2009. The team searched for a seizure signal to measure and monitor. After years of testing and developing, Brain Sentinel created a System that is able to harness a biomarker for seizure activity—and make it available to families that need it. In February 2017, the SPEAC® System became the first FDA-cleared, non-EEG, physiological, signal-based system for seizure monitoring. We are excited to make this technology available to families that have been struggling and looking for answers.
We understand because it’s personal to us.
Successful Clinical Trials – The SPEAC® System is Born
Brain Sentinel’s scientific team conducted an initial study in an Epilepsy Monitoring Unit (EMU) to compare the SparkSense™ algorithm’s analysis of recorded sEMG waveforms to the gold standard, video-electroencephalography (vEEG) data to identify GTC seizures (Szabo, 2015). The results found that the SparkSense™ algorithm’s analysis of sEMG was 95% specific as compared to the vEEG, thus, indicating that sEMG accurately reflects what is happening in the brain during a seizure.
At that point, the engineers got to work developing a portable seizure monitoring and alerting device. The SPEAC System was born. A larger FDA clinical trial including a larger number of patients was later conducted in eleven EMUs to confirm the efficacy of the SPEAC System using an active sEMG monitor on the belly of the biceps muscle.
What began as a project to develop a better wearable seizure detection device for a child evolved into the design of a highly sophisticated seizure monitoring and alerting system that can help in the diagnostic characterization of motor events. The breadth and quality of data recorded and analyzed by the SPEAC System can provide your physician with important information that can help him/her better manage your seizures.
Helping to Give You Peace of Mind – Seizure Monitoring that SPEAKS For You
Patients: Gain a bit more peace of mind while seizure activity is being closely monitored and your caregiver immediately notified when a GTC alarm goes off.
Caregivers: Gain a bit more peace of mind knowing your loved one can be heard by you and their doctor when being monitored by the SPEAC System.
Physicians: Gain a bit more peace of mind in your clinical impression and diagnosis of your patients’ conditions. Scientific clinical data provided by the SPEAC System helps you see, hear and characterize their motor seizure events. You have a new diagnostic tool to help you optimize the seizure management for your patients.
Committed to Further sEMG Research
Brain Sentinel plans to continue its research and development in the seizure market with three main areas of interest:
- Better understanding of motor seizure event types
- Identify the impact sEMG has on diagnostic decision making
- Quantify health and cost outcomes