Seizure Detection and Warning System for Epilepsy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epilepsy Patients

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

Brain Sentinel Seizure Detection Device and Warning System

Intervention Type DEVICE

The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring

Interventions

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Brain Sentinel Seizure Detection Device and Warning System

The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No