Endovascular thrombectomy (EVT) is the standard treatment for large vessel occlusion (LVO) strokes, but it can only be performed in specialized hospitals. Since ambulance personnel cannot determine if a patient is eligible for EVT, 54% of LVO stroke patients are initially taken to non-EVT-capable hospitals, resulting in an average delay of 1 hour in time-to-EVT in the Netherlands. To reduce this delay, it is crucial for ambulance personnel to identify potential LVO stroke patients and directly transport them to EVT-capable hospitals. Dry electrode electroencephalography (EEG) has shown high diagnostic accuracy for detecting LVO strokes, but in 32% of patients, the EEG signal quality was too poor to analyze.
To address this issue, TrianecT developed StrokePointer, a portable EEG-based triage device designed to collect and analyze EEG data in patients with suspected acute stroke. The objective of this study is to validate the effectiveness and safety of StrokePointer in detecting LVO stroke among patients with a suspected stroke in the pre-hospital setting.
Suspected acute stroke as per judgement of the ambulance personnel.
Age 18 years or older.
Onset of symptoms (or last seen well) <24 hours.
Written informed consent by patient or legal representative (deferred).
None
Single group
Dry electrode EEG
Diagnostic testA single dry electrode electroencephalography (EEG) will be performed in each patient that is included in this study. EEG data will be acquired with Strokepointer (TrianecT B.V., Utrecht, The Netherlands). StrokePointer is a portable EEG acquisition and analysis device. The device consists of three parts: (1) StrokePointer headset with dry electrodes to measure EEG data, (2) Portable StrokePointer suitcase that contains a mobile computing device (Android phone), CE-marked (IIa) EEG amplifier and storage compartments and (3) Software to acquire, analyse and upload EEG data.
Data quality of StrokePointer
Proportion of patients with a technically successful EEG dataset: at least 20 seconds of usable EEG (at least 3 electrodes with good skin-electrode quality on either side, no movement artifacts, no muscle artifacts) within a measurement time of 3 minutes.
Diagnostic accuracy of StrokePointer for LVO stroke
Diagnostic accuracy of StrokePointer for LVO stroke among patients with a suspected stroke, as measured with Area under the curve (AUC) as well as sensitivity and specificity
Predictive value of StrokePointer in identifying LVO stroke
Positive and negative predictive value of StrokePointer in identifying LVO stroke
User friendliness
User-friendliness rating of StrokePointer by ambulance personnel and researchers: (1) after the training 80% of the users should be able to start StrokePointer and start measuring EEG-data within 120s. (2) Interviewed users score (a) usability of StrokePointer hardware on average as "makkelijk" (easy) or better, (b) StrokePointer software on average as "duidelijk" (clear) or better.
Incidence of serious adverse device-related events (Safety of StrokePointer)
Provided that the device is being used in line with the intended use, there are no occurrences of serious adverse device-related events in the study.
Incidence of skin reactions (Safety of StrokePointer)
Number of patients with an (allergic) skin reaction observed at the site of the electrode.
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