Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

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.

Inclusion criteria

• Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
• Is being admitted to a hospital for routine vEEG monitoring related to seizures.
• Male or female between the ages of 2-99.
• Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
• If female and of childbearing potential, has a negative pregnancy test.
• Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
• Subject and/or Primary Caregiver must be competent to follow all study procedures.
• Is able to read, speak, and understand English.

Exclusion criteria

• Does not have a documented history of generalized seizures.
• Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
• Intracranial EEG electrodes are being used
• The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
• Pregnant female.
• Subject/Caregiver is unable to provide consent.