NCT03169751

An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Brain Sentinel · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.

Conditions

• Non-Epileptic Seizure
• Motor Seizure
• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2017-05-30
• Last updated: 2019-12-20

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study