Seizure Detection and Warning System for Epilepsy Patients
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|ClinicalTrials.gov Identifier: NCT01874600|
Recruitment Status : Active, not recruiting
First Posted : June 11, 2013
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment|
|Epilepsy||Device: Brain Sentinel Seizure Detection Device and Warning System|
|Study Type :||Observational|
|Actual Enrollment :||239 participants|
|Official Title:||A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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 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
- Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG. [ Time Frame: less than 1 month ]The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.
- Comparison of study device to self reporting of seizures using a seizure diary. [ Time Frame: Less than 1 month ]The secondary objective is to assess the operation of the Brain Sentinel Seizure Detection System when used in the subject's home and to compare the GTC seizure reporting of the device to a standard seizure diary completed by the subject/caregiver.
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): NCT01874600
|United States, Texas|
|San Antonio, Texas, United States, 78232-1399|
|Principal Investigator:||Jose' E Cavazos, MD, PhD||Brain Sentinel|
|Principal Investigator:||Dennis Dlugos, MD||Children's Hospital of Philadelphia|
|Principal Investigator:||Jonathan Halford, MD||Medical University of South Carolina|
|Principal Investigator:||Dileep Nair, MD||The Cleveland Clinic|