An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

Epilepsy Clinical Trial

Official title:

An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03169751
• Other study ID #: PNES-1.5-11.2016-EU
• Status: Active, not recruiting
• Start date: September 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: December 2019
• Source: Brain Sentinel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Motor Seizure
• Non-Epileptic Seizure
• Seizures

Intervention

Device:
• Brain Sentinel Monitoring and Alerting System
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.

Locations

Country	Name	City	State
Austria	Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Brain Sentinel

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG review. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG).	5 days
Primary	3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3)	The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG recorded by the SPEAC System. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). The sEMG record will be evaluated to identify PNES, displaying upper extremity motor components, and epileptic seizures, displaying upper extremity (UE) motor components. It is anticipated that > 70% of PNES with UE motor involvement identified by vEEG will be identified by sEMG recordings as well.	5 days
Secondary	To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring	It is anticipated that >70% of GTC seizures identified by vEEG will be identified by the SPEAC System's automated alarms as well.	5 days