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This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
The Brain Sentinelâ„¢ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Sentinel Seizure Detection and Warning System | To test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Sentinel Seizure Detection and Warning System | Device | A sEMG based automated seizure detection and warning system worn on the biceps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions. | The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting. | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the accuracy of the EMG based system's log to the subject's seizure diary | Comparison of the subject's seizure diary to the EMG based seizure detection system's seizure logs will help determine overall function. | up to one month |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization
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| Name | Affiliation | Role |
|---|---|---|
| Jose E. Cavazos, MD, PhD | Brain Sentinel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jose' E. Cavazos | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |