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.

StrokePointer EEG device. 

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.