Seizure Detection and Warning System for Epilepsy Patients
Status unconfirmed
Conditions studied: Epilepsy
In brief
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.
Key facts
- Study ID
- NCT01874600
- Run by
- Brain Sentinel
- People needed
- 239
- Starts
- 2013-07-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2019-07-10
Who can join
Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Brain Sentinel — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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