Seizure Detection and Warning System for Epilepsy Patients

• Conditions: Epilepsy
• Interventions: Device: Brain Sentinel Seizure Detection Device and Warning System

• Registration Number: NCT01874600
• Lead Sponsor: Brain Sentinel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Study Start: 2013-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy Patients	Brain Sentinel Seizure Detection Device and Warning System	This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.

Primary Outcome Measures

Name	Time	Method
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.	less than 1 month	The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.

Secondary Outcome Measures

Name	Time	Method
Comparison of study device to self reporting of seizures using a seizure diary.	Less than 1 month	The secondary objective is to assess the operation of the Brain Sentinel Seizure Detection System when used in the subject's home and to compare the GTC seizure reporting of the device to a standard seizure diary completed by the subject/caregiver.

Trial Locations

Locations (1)

Brain Sentinel; 🇺🇸 San Antonio, Texas, United States