A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 2 - 99 |
| Updated: | 1/6/2017 |
| Start Date: | May 2016 |
| End Date: | January 2017 |
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.
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.
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.
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