Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography

What this Trial Is About

Researchers are evaluating a portable EEG-based triage device called StrokePointer to detect large vessel occlusion (LVO) strokes in patients suspected of acute stroke in the pre-hospital setting. The study aims to validate the safety and effectiveness of StrokePointer, which could help ambulance personnel identify LVO strokes early and reduce delays in transferring patients to specialized hospitals capable of performing endovascular thrombectomy (EVT). Each participant will undergo a single dry electrode EEG measurement using the StrokePointer headset, which records brain activity for about two minutes. The device includes a headset, portable suitcase with a mobile computing device and EEG amplifier, and software for data acquisition and analysis. The study is a prospective, multi-center cohort design focused on adult patients with suspected stroke symptoms starting less than 24 hours prior. Participants will have EEG data collected and analyzed to assess data quality and diagnostic accuracy for LVO stroke detection. Clinical and radiological information will also be gathered. Researchers will monitor safety by tracking adverse device-related events and skin reactions. The study will evaluate usability based on ambulance personnel feedback. The total involvement includes the EEG procedure performed in the ambulance before hospital arrival, with outcomes measured within 24 hours of symptom onset.

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