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:

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

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

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

4. Be able to tolerate wearing the device on the upper arm.

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

3. Pregnant female

4. Subject/Caregiver is unable to provide consent.

5. Subject/Caregiver is not competent to follow home study procedures.

6. The subject is homeless or in a home without a power supply.