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Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02344706
Recruitment Status : Not yet recruiting
First Posted : January 26, 2015
Last Update Posted : August 8, 2018
Information provided by (Responsible Party):
Johannes Björkman, Helsinki University Central Hospital

Brief Summary:
A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.

Condition or disease Intervention/treatment
Epilepsy Status Epilepticus Device: Registration of EEG

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : January 1, 2022

Group/Cohort Intervention/treatment
Unconscious patients due to seizures, of whom EEG is registered
Device: Registration of EEG
EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.

Primary Outcome Measures :
  1. Diagnostic value of EEG [ Time Frame: 60min ]
    EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients unconscious due to seizures in the prehospital field

Inclusion Criteria:

  • Unconsciousness due to seizures in the prehospital field

Exclusion Criteria:

  • Cardiac arrest
  • Traumatic unconsciousness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02344706

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Contact: Johannes Björkman, MD 094711
Contact: Tom Silfvast, MD, PhD 094711

Sponsors and Collaborators
Helsinki University Central Hospital
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Study Director: Tom Silfvast, MD, Phd Helsinki University Central Hospital
Principal Investigator: Johannes Björkman, MD Helsinki University Central Hospital
Study Director: Salmi Tapani, MD, PHD Helsinki University Central Hospital

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Responsible Party: Johannes Björkman, Resident, Helsinki University Central Hospital Identifier: NCT02344706     History of Changes
Other Study ID Numbers: 237/3 03.12.2012
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Keywords provided by Johannes Björkman, Helsinki University Central Hospital:
Emergency Care, Prehospital
Additional relevant MeSH terms:
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Status Epilepticus
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms