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Detecting PNES With Single-channel sEMG

Primary Purpose

Epilepsy, Motor Partial, Psychogenic Seizures

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPEAC System
video EEG
Sponsored by
Brain Sentinel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy, Motor Partial

Eligibility Criteria

22 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VAMC
  • Michael E DeBakey VA Medical Center
  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects admitted to Epilepsy Monitoring Units in the VAMC

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 10, 2017
Last Updated
December 18, 2019
Sponsor
Brain Sentinel
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1. Study Identification

Unique Protocol Identification Number
NCT03313362
Brief Title
Detecting PNES With Single-channel sEMG
Official Title
Detecting PNES With Single-channel sEMG
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brain Sentinel

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Motor Partial, Psychogenic Seizures

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects admitted to Epilepsy Monitoring Units in the VAMC
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
SPEAC System
Other Intervention Name(s)
Brain Sentinel Seizure Monitoring and Alerting System
Intervention Description
Seizure Monitoring and Alerting System
Intervention Type
Device
Intervention Name(s)
video EEG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.
Description
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 Outcome Measure Information:
Title
To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aatif Husain, MD
Organizational Affiliation
Epilepsy Center of Excellence (ECoE) at the Durham VA Medical Center in Durham, North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Towne, MD
Organizational Affiliation
Epilepsy Center of Excellence (ECoE) at Hunter Holmes McGuire VA Medical Center in Richmond, Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Chen, MD
Organizational Affiliation
Epilepsy Center of Excellence (ECoE) at the Michael E. DeBakey VA Medical Center in Houston, Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Michael E DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

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Detecting PNES With Single-channel sEMG

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