Detecting PNES With Single-channel sEMG

NCT ID: NCT03313362

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-03

Study Completion Date

2020-02-29

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.

Detailed Description

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Conditions

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Epilepsy, Motor Partial Psychogenic Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

SPEAC System

Intervention Type DEVICE

Seizure Monitoring and Alerting System

video EEG

Intervention Type 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.

Interventions

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SPEAC System

Seizure Monitoring and Alerting System

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Brain Sentinel Seizure Monitoring and Alerting System

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain Sentinel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aatif Husain, MD

Role: PRINCIPAL_INVESTIGATOR

Epilepsy Center of Excellence (ECoE) at the Durham VA Medical Center in Durham, North Carolina

Alan Towne, MD

Role: PRINCIPAL_INVESTIGATOR

Epilepsy Center of Excellence (ECoE) at Hunter Holmes McGuire VA Medical Center in Richmond, Virginia

David Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Epilepsy Center of Excellence (ECoE) at the Michael E. DeBakey VA Medical Center in Houston, Texas

Locations

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Durham VAMC

Durham, North Carolina, United States

Site Status

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Site Status

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PNES-1.5-01.2017

Identifier Type: -

Identifier Source: org_study_id