Seizure Detection and Warning System in Epilepsy Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pivotal, Phase II Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

Conditions
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Epilepsy, Generalized Tonic-Clonic Seizures

Intervention / Treatment
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* Device: Brain Sentinel Seizure Detection and Warning System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization. Male or female between the ages of 2-99. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm). Be able to tolerate wearing the device on the upper arm. If female and of childbearing potential, has a negative pregnancy test. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments. Subject and/or Primary Caregiver must be competent to follow all study procedures. Is able to read, speak and understand English. Exclusion Criteria: Does not have a documented history of generalized seizures. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm) Pregnant female Subject/Caregiver is unable to provide consent. Subject/Caregiver is not competent to follow home study procedures. The subject is homeless or in a home without a power supply.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brain Sentinel Seizure Detection and Warning System<br>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<br>* A sEMG based automated seizure detection and warning system worn on the biceps<br>* Other names: SPEAC System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |