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RECRUITING
NCT06871969
NA

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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2025-07-01

Completion Date

2026-12

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Dry electrode EEG

A 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.

Locations (1)

Amsterdam University Medical Centers, location AMC

Amsterdam, North Holland, Netherlands