Detecting PNES With Single-channel sEMG

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 Overview

• Status: Unknown
• Conditions: Epilepsy, Motor Partial; Psychogenic Seizures
• Intervention / Treatment: Device: SPEAC System; Device: video EEG

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VAMC
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E DeBakey VA Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects admitted to Epilepsy Monitoring Units in the VAMC; 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; Seizure Monitoring and Alerting System; Other Names: Brain Sentinel Seizure Monitoring and Alerting System; Device: video EEG; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brain Sentinel
• Investigators: Principal Investigator: Aatif Husain, MD, Epilepsy Center of Excellence (ECoE) at the Durham VA Medical Center in Durham, North Carolina; Principal Investigator: Alan Towne, MD, Epilepsy Center of Excellence (ECoE) at Hunter Holmes McGuire VA Medical Center in Richmond, Virginia; Principal Investigator: David Chen, MD, Epilepsy Center of Excellence (ECoE) at the Michael E. DeBakey VA Medical Center in Houston, Texas

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Actual): June 21, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Epilepsies, Partial; Seizures; Epilepsy, Partial, Motor
• Other Study ID Numbers: PNES-1.5-01.2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes