Cerebrovasculair accident, Stroke, Large vessel occlusion
Conditions
Interventions
StrokePointer EEG device. 
NovaGuide2 TCD device.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Suspected acute ischemic stroke as per judgement by 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)
Exclusion criteria
Exclusion criteria: - Injuries or infections of the scalp in the area of the electrode cap or TCD probe placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EEG-study - 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 among patients with a suspected stroke, as measured with AUC as well as sensitivity and specificity.TCD sub-study - Proportion of patients with meaningful TCD data (bilateral 30 second segments, depth range 40-65 millimetre, at least 30 accepted beats) obtained with the NovaGuide2 in patients with a suspected (acute) stroke in the ambulance. - Diagnostic accuracy of NovaGuide2 for LVO stroke among patients with a suspected stroke, as measured with sensitivity and specificity. | — |
Secondary
| Measure | Time frame |
|---|---|
| EEG study - Positive and negative predictive value of StrokePointer in identifying LVO stroke. - 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. - Diagnostic accuracy for identifying LVO stroke within the following subgroups: sex (men vs. women) and age (above vs. below 60), as measured with sensitivity and specificity. - Discriminative power of StrokePointer for ischemic stroke vs stroke mimic as measured with Area under the curve (AUC) as well as sensitivity and specificity. TCD-substudy - Positive and negative predictive value of NovaGuide2 in identifying LVO stroke. - User-friendliness rating of NovaGuide2 by ambulance personnel and researchers: (1) after the training 80% of the users should be able to start NovaGuide2 and start measuring TCD-data within 120s. (2) Interviewed users score (a) usability of NovaGuide2 hardware on average as “makkelijk” (easy) or better, (b) NovaGuide2 software on average as “duidelijk” (clear) or better. - Incidence of serious adverse device-related events (Safety) of NovaGuide2. 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 observed at the site of the TCD-probe. - Diagnostic accuracy | — |
Countries
Netherlands
Contacts
Public ContactJ. Coutinho
Amsterdam UMC
Outcome results
None listed