A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization

TerminatedOBSERVATIONAL
Enrollment

5

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

January 31, 2017

Study Completion Date

February 28, 2017

Conditions
Epilepsy
Interventions
DEVICE

Brain Sentinel Seizure Detection and Information System

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.

Trial Locations (1)

43205

Nationwide Children's Hospital, Columbus

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Nationwide Children's Hospital

OTHER

lead

Brain Sentinel

OTHER

NCT02752373 - A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization | Biotech Hunter | Biotech Hunter