An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

Brain Sentinel

Status: Unknown

Conditions: Epilepsy; Non-Epileptic Seizure; Motor Seizure

Treatments: Device: Brain Sentinel Monitoring and Alerting System

Study type: Observational

Funder types: Other

Identifiers

NCT03169751

PNES-1.5-11.2016-EU

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures 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 of 18-99.
4. If female and of childbearing potential, has a negative pregnancy test.
5. Can understand and sign written informed consent prior to the performance of any study assessments.
6. Subject must be competent to follow all study procedures.

Exclusion criteria

1.Intracranial EEG electrodes are being used.

Trial design

71 participants in 2 patient groups

PNES Cohort

Description:

Participants who experience a non-epileptic event with upper extremity motor involvement, while enrolled in the trial

Treatment:

Device: Brain Sentinel Monitoring and Alerting System

Epileptic Cohort

Description:

Participants who experience an epileptic event with upper extremity motor involvement, while enrolled in the trial

Treatment:

Device: Brain Sentinel Monitoring and Alerting System