This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.
Study Type
OBSERVATIONAL
Enrollment
11
A sEMG based automated seizure detection and warning system worn on the biceps
Jose' E. Cavazos
San Antonio, Texas, United States
Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.
The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting.
Time frame: up to 1 month
Compare the accuracy of the EMG based system's log to the subject's seizure diary
Comparison of the subject's seizure diary to the EMG based seizure detection system's seizure logs will help determine overall function.
Time frame: up to one month
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