An observational study in Epilepsy and Generalized Tonic-Clonic Seizures, sponsored by Brain Sentinel. Completed at 1 site in United States. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-07-12.
Sponsored by Brain Sentinel · Observational
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 Sentinel™ 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.
1,806 studies on the registry are indexed under Epilepsy; 418 are open to participants now.
This study's enrollment of 11 is below the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Brain Sentinel is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization
Exclusion Criteria:
To test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting.
Device: Brain Sentinel Seizure Detection and Warning System
A sEMG based automated seizure detection and warning system worn on the biceps
Also known as: SPEAC System
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.
Time frame: up to 1 month
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.
Time frame: up to one month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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