Detecting PNES With Single-channel sEMG

Study Overview
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Brief Summary
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This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.

Official Title
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Detecting PNES With Single-channel sEMG

Conditions
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Epilepsy, Motor Partial, Psychogenic Seizures

Intervention / Treatment
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* Device: SPEAC System
* Device: video EEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement. Is being admitted to a hospital for routine vEEG monitoring related to seizures. Male or Female between the ages 22 to 99. If female and of childbearing potential, has a negative pregnancy test and must not be nursing. 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. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study. Exclusion Criteria: Intracranial EEG electrodes are being used.

Ages Eligible for Study
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Minimum Age: 22 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects admitted to Epilepsy Monitoring Units in the VAMC<br>Subjects being monitored by standard of care, video EEG, in the Epilepsy Monitoring Units in the VAMC will all be placed on a Seizure Monitoring and Alerting System (SPEAC System). | Device: SPEAC System<br>* Seizure Monitoring and Alerting System<br>* Other names: Brain Sentinel Seizure Monitoring and Alerting System;Device: video EEG<br>* The Video EEG Monitoring Test (VEEG) is a high specialized form of an EEG test in where the patient is continuosly monitored by using a video recorder. This allows doctors to observe brainwaves activity during the time a seizure or spell is occurring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio. | To test the null hypothesis that three independent epileptologists categorize, by majority vote, epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases using sEMG and audio. We aim to test the null hypothesis that the epileptologists categorize epileptic seizures and psychogenic non-epileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic. | Test the null hypothesis that the Brain Sentinel® Seizure Monitoring and Alerting System categorizes epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases. We aim to test the null hypothesis that the Brain Sentinel® Seizure Monitoring and Alerting System's software categorizes epileptic seizures and psychogenic Nonepileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test. | 1 Year |