Seizure Detection and Warning System in Epilepsy Patients

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.

Inclusion criteria

• Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
• 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).
• Be able to tolerate wearing the device on the upper arm.
• 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.
• 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.
• Subject/Caregiver is not competent to follow home study procedures.
• The subject is homeless or in a home without a power supply.