UnknownNot Applicable

An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

Austria71 participantsStarted 2017-09-01

Plain-language summary

This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.

Who can participate

Age range18 Years – 99 Years

SexALL

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 suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement.
✓. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
✓. Male or female between the ages of 18-99.
✓. If female and of childbearing potential, has a negative pregnancy test.
✓. Can understand and sign written informed consent prior to the performance of any study assessments.
✓. Subject must be competent to follow all study procedures.

Exclusion criteria

✕.Intracranial EEG electrodes are being used.

What they're measuring

3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3)

Timeframe: 5 days

Trial details

NCT IDNCT03169751

SponsorBrain Sentinel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-02-01

View on ClinicalTrials.gov More Non-Epileptic Seizure trials