Seizure Detection and Warning System for Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.

Inclusion Criteria:

1. Subject has a suspected 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 13-21.
4. If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
5. 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.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Is able to read, speak, and understand English or has a LAR that does so.
8. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria:

1. 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.
2. Intracranial EEG electrodes are being used.
3. The subject is allergic to adhesives or any component of the electrode patch assembly