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An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures

NCT03169751 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2019-12-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Brain Sentinel

    lead OTHER

Principal Investigators

  • Christoph Baumgartner, MD · Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Device
Yes

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169751 on ClinicalTrials.gov