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

 1. Subject has a history of GTC seizures, either primary GTC or partial onset seizures
 with secondary generalization.

 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.

 3. Male or female between the ages of 2-99.

 4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at
 least 14cm).

 5. If female and of childbearing potential, has a negative pregnancy test.

 6. 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.

 7. Subject and/or Primary Caregiver must be competent to follow all study procedures.

 8. Is able to read, speak, and understand English.

 Exclusion Criteria:

 1. Does not have a documented history of generalized seizures.

 2. 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.

 3. Intracranial EEG electrodes are being used

 4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor
 (less than 14cm).

 5. Pregnant female.

 6. Subject/Caregiver is unable to provide consent.