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Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

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ClinicalTrials.gov Identifier: NCT02344706
Recruitment Status : Not yet recruiting
First Posted : January 26, 2015
Last Update Posted : August 8, 2018
Sponsor:
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

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
Mini-EEG, NCSE
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)



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02344706


Contacts
Contact: Johannes Björkman, MD 094711 johannes.bjorkman@helsinki.fi
Contact: Tom Silfvast, MD, PhD 094711

Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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

Responsible Party: Johannes Björkman, Resident, Helsinki University Central Hospital
ClinicalTrials.gov 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
Coma
Electroencephalography

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases