Status:
UNKNOWN
Seizure Detection and Warning System for Epilepsy Patients
Lead Sponsor:
Brain Sentinel
Conditions:
Epilepsy
Eligibility:
All Genders
13-21 years
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...
Eligibility Criteria
Inclusion
- Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- Male or female between the ages of 13-21.
- If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
- 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.
- Subject and/or Primary Caregiver must be competent to follow all study procedures.
- Is able to read, speak, and understand English or has a LAR that does so.
- Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.
Exclusion
- 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.
- Intracranial EEG electrodes are being used.
- The subject is allergic to adhesives or any component of the electrode patch assembly
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01874600
Start Date
July 1 2013
End Date
December 1 2019
Last Update
July 10 2019
Active Locations (1)
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1
Brain Sentinel
San Antonio, Texas, United States, 78232-1399