Detecting PNES With Single-channel sEMG

Not Applicable

• Conditions: Epilepsy, Motor Partial; Psychogenic Seizures

• Registration Number: NCT03313362
• Lead Sponsor: Brain Sentinel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-18
• Study Start: 2017-11-03
• Primary Completion: 2019-06-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.	1 year	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

Name	Time	Method
To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.	1 Year	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.

Trial Locations

Locations (3)

Durham VAMC; 🇺🇸 Durham, North Carolina, United States

Michael E DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States