Seizure Detection and Warning System for Epilepsy Patients

Brain Sentinel

Status: Unknown

Conditions: Epilepsy

Treatments: Device: Brain Sentinel Seizure Detection Device and Warning System

Study type: Observational

Funder types: Other

Identifiers

NCT01874600

BS-0421

Details and patient eligibility

About

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.

Enrollment: 239 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a suspected 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 13-21.
4. If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
5. 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.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Is able to read, speak, and understand English or has a LAR that does so.
8. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion criteria

1. 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.
2. Intracranial EEG electrodes are being used.
3. The subject is allergic to adhesives or any component of the electrode patch assembly

Trial design

239 participants in 1 patient group

Epilepsy Patients

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 Device and Warning System