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

Brain Sentinel

Status: Completed

Conditions: Generalized Tonic-Clonic Seizures; Epilepsy

Treatments: Device: Brain Sentinel Seizure Detection and Warning System

Study type: Observational

Funder types: Other

Identifiers

NCT02371200

GTC-1.5-09.2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 2 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 2-99.
4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
5. If female and of childbearing potential, has a negative pregnancy test.
6. 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.
7. Subject and/or Primary Caregiver must be competent to follow all study procedures.
8. Is able to read, speak, and understand English.

Exclusion criteria

1. Does not have a documented history of generalized seizures.
2. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
3. Intracranial EEG electrodes are being used
4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
5. Pregnant female.
6. Subject/Caregiver is unable to provide consent.

Trial design

13 participants in 1 patient group

Brain Sentinel Seizure Detection and Warning System

Description:

This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.

Treatment:

Device: Brain Sentinel Seizure Detection and Warning System