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

NCT06871969 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06871969 on ClinicalTrials.gov