Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

Epilepsy Clinical Trial

Official title:

Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02344706
• Other study ID #: 237/3 03.12.2012
• Status: Not yet recruiting
• Start date: December 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2018
• Source: Helsinki University Central Hospital
• Contact: Johannes Björkman, MD
• Phone: 094711
• Email: johannes.bjorkman[@]helsinki.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unconsciousness due to seizures in the prehospital field

Exclusion Criteria:

• Cardiac arrest

• Traumatic unconsciousness

Related Conditions & MeSH terms

• Epilepsy
• Status Epilepticus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value of EEG	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)	60min