An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

• Conditions: Epilepsy; Non-Epileptic Seizure; Motor Seizure
• Interventions: Device: Brain Sentinel Monitoring and Alerting System

• Registration Number: NCT03169751
• Lead Sponsor: Brain Sentinel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Study Start: 2017-09-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epileptic Cohort	Brain Sentinel Monitoring and Alerting System	Participants who experience an epileptic event with upper extremity motor involvement, while enrolled in the trial
PNES Cohort	Brain Sentinel Monitoring and Alerting System	Participants who experience a non-epileptic event with upper extremity motor involvement, while enrolled in the trial

Primary Outcome Measures

Name	Time	Method
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)	5 days	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).
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)	5 days	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring	5 days	It is anticipated that \>70% of GTC seizures identified by vEEG will be identified by the SPEAC System's automated alarms as well.

Trial Locations

Locations (1)

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel; 🇦🇹 Wien, Austria