An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

Study Overview
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Brief Summary
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This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.

Official Title
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An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

Conditions
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Epilepsy, Non-Epileptic Seizure, Motor Seizure

Intervention / Treatment
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* Device: Brain Sentinel Monitoring and Alerting System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement. Is being admitted to a hospital for routine vEEG monitoring related to seizures. Male or female between the ages of 18-99. If female and of childbearing potential, has a negative pregnancy test. Can understand and sign written informed consent prior to the performance of any study assessments. Subject must be competent to follow all study procedures. Exclusion Criteria: 1.Intracranial EEG electrodes are being used.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| PNES Cohort<br>Participants who experience a non-epileptic event with upper extremity motor involvement, while enrolled in the trial | Device: Brain Sentinel Monitoring and Alerting System<br>* The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.<br>|
| Epileptic Cohort<br>Participants who experience an epileptic event with upper extremity motor involvement, while enrolled in the trial | Device: Brain Sentinel Monitoring and Alerting System<br>* The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3) | The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG review. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). | 5 days | 
| 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3) | The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG recorded by the SPEAC System. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). The sEMG record will be evaluated to identify PNES, displaying upper extremity motor components, and epileptic seizures, displaying upper extremity (UE) motor components. It is anticipated that > 70% of PNES with UE motor involvement identified by vEEG will be identified by sEMG recordings as well. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring | It is anticipated that >70% of GTC seizures identified by vEEG will be identified by the SPEAC System's automated alarms as well. | 5 days |