Detecting PNES With Single-channel sEMG

NCT03313362 | Unknown FDA Device

• 1 other identifier: PNES-1.5-01.2017
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Epilepsy, Motor Partial; Psychogenic Seizures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.

  1 Year

Study Arms (1)

Subjects admitted to Epilepsy Monitoring Units in the VAMC

EXPERIMENTAL

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; Device: video EEG

Interventions

SPEAC System DEVICE

Seizure Monitoring and Alerting System

Also known as: Brain Sentinel Seizure Monitoring and Alerting System

Subjects admitted to Epilepsy Monitoring Units in the VAMC

video EEG DEVICE

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.

Subjects admitted to Epilepsy Monitoring Units in the VAMC

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intracranial EEG electrodes are being used.

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (3)

Durham VAMC

Durham, North Carolina, 27705, United States

Location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Epilepsy, Partial, Motor; Psychogenic Nonepileptic Seizures

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Seizures; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 18, 2017
• Study Start: November 3, 2017
• Primary Completion: June 21, 2019
• Study Completion: February 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (3)