An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

NCT03169751 | Unknown FDA Device

• 1 other identifier: PNES-1.5-11.2016-EU
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Epileptic Seizure; Motor Seizure; Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring

  5 days

Study Arms (2)

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

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

Interventions

Brain Sentinel Monitoring and Alerting System DEVICE

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; PNES Cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Intracranial EEG electrodes are being used.

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (1)

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Christoph Baumgartner, MD

  Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 30, 2017
• Study Start: September 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)