Detecting PNES With Single-channel sEMG

Brain Sentinel71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Epilepsy, Motor Partial Psychogenic Seizures

Interventions

SPEAC SystemDEVICE

Seizure Monitoring and Alerting System

video EEGDEVICE

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement. 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures. 3. Male or Female between the ages 22 to 99. 4. If female and of childbearing potential, has a negative pregnancy test and must not be nursing. 5. 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. 6. Subject and/or Primary Caregiver must be competent to follow all study procedures. 7. 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.

Locations (3)

Durham VAMC

Durham, North Carolina, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 1 Year

Data from ClinicalTrials.gov

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