NCT02371200

Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Brain Sentinel · Academic / Other
• Sex: All
• Age: 2 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.

Detailed description

This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.

Conditions

• Epilepsy
• Generalized Tonic-Clonic Seizures

Interventions

Type	Name	Description
DEVICE	Brain Sentinel Seizure Detection and Warning System	The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2015-02-25
• Last updated: 2018-07-10

Locations

2 sites across 1 country: United States