A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
This is an open label prospective study of the impact on healthcare utilization of a surface
 Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic
 (GTC) Seizures.
The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system
 designed to continuously monitor and perform real-time analysis of surface electromyography
 (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30
 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System
 is for recording and storing sEMG data, which is subsequently reviewed by a trained
 healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure
 Detection and Information System is intended for real time monitoring of pediatric and adult
 patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm
 at the biceps. It may be used in the home or healthcare facilities for real-time monitoring
 during the day, night, or for continuous monitoring, including during the titration of, or
 the withdrawal from anti-epileptic drugs.
Inclusion Criteria:

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

 -  Male or female greater than 2 years of age

 -  Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at
 least 16-51 cm)

 -  Be able to tolerate wearing the device on the upper arm

 -  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

 -  At least 2 or more Emergency Department visits in the previous 12 months for seizure
 related care

 Exclusion Criteria:

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

 -  The subject is allergic to adhesives or any component of the electrode patch assembly.

 -  The subject self-reports that she is pregnant or planning to become pregnant while
 using the device.