Epilepsy Clinical Trial
Official title:
A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.
This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting. ;
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