Clinical evaluation of pre-hospital stroke triage devices- Electroencephalography

Endovascular thrombectomy (EVT) is the standard treatment for large vessel
occlusion (LVO) stroke. However, EVT can only be performed in specialized
hospitals and its effect on functional outcome rapidly decreases with passing
time (time = brain). Since ambulance personnel cannot determine whether a
patient has a stroke that is eligible for EVT, 54% of patients with an LVO
stroke are primarily presented at a non-EVT capable hospital. These patients
then require interhospital transfer, resulting in average delay in time-to-EVT
of 1 hour in the Netherlands. Therefore, providing ambulance personnel with
tools to identify patients with a possible LVO stroke in the ambulance,
allowing direct transport to an EVT capable hospital, is much needed. Dry
electrode electroencephalography (EEG) has shown to have a high diagnostic
accuracy for LVO stroke detection among patients with a suspected stroke (area
under the receiving operating curve [AUC]: 0.91). However, in 32% of patients
EEG signal quality was too poor to analyse. A new portable EEG-based triage
device (StrokePointer) has been developed by TrianecT with the aim to collect
and analyse EEG data in patients suspected of acute stroke. In this study, we
intend to validate the safety and effectiveness of the device.

Primary objective:
1. To validate the data quality and diagnostic accuracy of StrokePointer to
detect LVO stroke among patients with a suspected stroke in the pre-hospital
setting.

Secondary objectives:
1. To determine the user-friendliness of StrokePointer according to ambulance
personnel.
2. To determine safety performance of StrokePointer.
3. Diagnostic accuracy and data quality for LVO stroke within the following
subgroups: sex (men vs. women) and age (above vs. below 60).
4. Discriminative power of StrokePointer for ischemic stroke vs. stroke mimic.

CROSSROADS-EEG is an investigator-initiated, prospective, multi-centre cohort
study.

A single EEG recording will be performed in each patient. An EEG recording is a
safe and non-invasive procedure, regularly performed in standard medical
practice. The use of dry electrodes makes it possible to perform the
measurement in less than five minutes and cause no to minimal delay. We expect
no health risks. The treating physicians and the ambulance personnel will not
interpret the EEG recording, therefore the EEG results will not influence
choices regarding diagnosis, treatment or the hospital to which the patient is
presented. Deferred informed consent will be asked, and if informed consent is
given, a case report form (CRF) will be filled out containing information on
patient characteristics, medical history, medication use, physical and
neurological examination performed by the treating physician, results of
imaging studies, diagnosis and treatment as well as logistical and technical
information, obtained from the patient, the treating physician and the
Emergency Medical Service (EMS). There are no follow up visits. For the
patient, there is no benefit of participation in the study.