An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

UnknownOBSERVATIONAL
Enrollment

71

Participants

Timeline

Start Date

September 1, 2017

Primary Completion Date

February 1, 2020

Study Completion Date

February 1, 2020

Conditions
Non-Epileptic SeizureMotor SeizureEpilepsy
Interventions
DEVICE

Brain Sentinel Monitoring and Alerting System

The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.

Trial Locations (1)

1130

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Vienna

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Brain Sentinel

OTHER

NCT03169751 - An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures | Biotech Hunter | Biotech Hunter