Status:

UNKNOWN

Detecting PNES With Single-channel sEMG

Lead Sponsor:

Brain Sentinel

Conditions:

Epilepsy, Motor Partial

Psychogenic Seizures

Eligibility:

All Genders

22-99 years

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • 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

  • Intracranial EEG electrodes are being used.

Key Trial Info

Start Date :

November 3 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2020

Estimated Enrollment :

71 Patients enrolled

Trial Details

Trial ID

NCT03313362

Start Date

November 3 2017

End Date

February 1 2020

Last Update

December 20 2019

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Durham VAMC

Durham, North Carolina, United States, 27705

2

Michael E DeBakey VA Medical Center

Houston, Texas, United States, 77030

3

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States, 23249