An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

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.

Study Overview

• Status: Unknown
• Conditions: Epilepsy; Non-Epileptic Seizure; Motor Seizure
• Intervention / Treatment: Device: Brain Sentinel Monitoring and Alerting System

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1130
    • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People with a suspected history of Psychogenic Non Epileptic Seizures with upper extremity motor involvement. and/or Epileptic Seizures with upper extremity motor involvement

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PNES Cohort; Participants who experience a non-epileptic event with upper extremity motor involvement, while enrolled in the trial	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.
Epileptic Cohort; Participants who experience an epileptic event with upper extremity motor involvement, while enrolled in the trial	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brain Sentinel
• Investigators: Principal Investigator: Christoph Baumgartner, MD, Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): February 1, 2020

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: PNES-1.5-11.2016-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes