Clinical Evaluation of EEG Device for the Triage of Stroke Patients in the Ambulance

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.

NCT Number	NCT06871969
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions	Ischemic Stroke, Stroke, Cardiovascular Diseases, Vascular Diseases, Central Nervous System Diseases, Brain Diseases, Nervous System Diseases, Cerebrovascular Disease
Enrollment	275 participants
Start Date	2025-07-01
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-10-03