Seizure Detection and Warning System for Epilepsy Patients
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 13 - 21 |
| Updated: | 11/10/2018 |
| Start Date: | July 2013 |
| End Date: | December 2019 |
A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
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.
analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert
caregivers that a seizure is occurring.
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
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