UnknownNot Applicable

Detecting PNES With Single-channel sEMG

United States71 participantsStarted 2017-11-03

Plain-language 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.

Who can participate

Age range

22 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT03313362

SponsorBrain Sentinel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-21

View on ClinicalTrials.gov More Epilepsy, Motor Partial trials