Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
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|ClinicalTrials.gov Identifier: NCT02371200|
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : July 10, 2018
|Condition or disease||Intervention/treatment|
|Epilepsy Generalized Tonic-Clonic Seizures||Device: Brain Sentinel Seizure Detection and Warning System|
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||February 2018|
Brain Sentinel Seizure Detection 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.
Device: Brain Sentinel Seizure Detection and Warning System
The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.
Other Name: SPEAC System
- Sensitivity of the Seizure Detection System [ Time Frame: up to 1 month ]The primary outcome measure for this clinical trial will be the sensitivity of the Brain Sentinel™ Seizure Detection Systems ability to detect GTC seizure activity in comparison to a Neurologist independent review of vEEG collected in an epilepsy monitoring unit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371200
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Charles Szabo, MD||University Health System of San Antonio|