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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epilepsy Patients | This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Sentinel Seizure Detection Device and Warning System | Device | The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG. | 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. | less than 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of study device to self reporting of seizures using a seizure diary. | 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. | Less than 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Sentinel | San Antonio | Texas | 78232-1399 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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