71
Participants
Start Date
September 1, 2017
Primary Completion Date
February 1, 2020
Study Completion Date
February 1, 2020
Brain Sentinel Monitoring and Alerting System
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Vienna
Lead Sponsor
Brain Sentinel
OTHER