Clinical Evaluation of EEG Device for the Triage of Stroke Patients in the Ambulance (CROSSROADS-EEG)

September 30, 2025 updated by: Jonathan Coutinho, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

RATIONALE Endovascular thrombectomy (EVT) is the standard treatment for large vessel occlusion (LVO) stroke. However, EVT can only be performed in specialized hospitals and its effect on functional outcome rapidly decreases with passing time (time = brain). Since ambulance personnel cannot determine whether a patient has a stroke that is eligible for EVT, 54% of patients with an LVO stroke are primarily presented at a non-EVT capable hospital. These patients then require interhospital transfer, resulting in average delay in time-to-EVT of 1 hour in the Netherlands. Therefore, providing ambulance personnel with tools to identify patients with a possible LVO stroke in the ambulance, allowing direct transport to an EVT capable hospital, is much needed. Dry electrode electroencephalography (EEG) has shown to have a high diagnostic accuracy for LVO stroke detection among patients with a suspected stroke (area under the receiving operating curve [AUC]: 0.91). However, in 32% of patients EEG signal quality was too poor to analyse. A new portable EEG-based triage device (StrokePointer) has been developed by TrianecT with the aim to collect and analyse EEG data in patients suspected of acute stroke. In this study, we intend to validate the safety and effectiveness of the device.

HYPOTHESIS:

  1. StrokePointer device can measure EEG data of sufficient quality in >85% of patients, and has a good diagnostic accuracy (AUC>0.8) for LVO stroke detection in the pre-hospital setting.
  2. Usability of StrokePointer device is rated as "good" on average by ambulance personnel.
  3. StrokePointer is safe to use in an acute care setting.

OBJECTIVE Primary objective is to validate the data quality and diagnostic accuracy of StrokePointer to detect LVO stroke among patients with a suspected stroke in the pre-hospital setting.

STUDY DESIGN CROSSROADS-EEG is an investigator-initiated, prospective, multi-centre cohort study.

STUDY POPULATION Adult patients with a suspected stroke, onset of symptoms (or last seen well) <24 hours in the pre-hospital setting.

INTERVENTION A single measurement with a dry electrode headset EEG (approximately 2 minutes recording duration) will be performed in each patient. Clinical and radiological data will be collected. EEG data will be acquired with the improved TrianecT EEG device, StrokePointer.

MAIN STUDY END POINTS

  • 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.

Study Type

Interventional

Enrollment (Estimated)

275

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105AZ
        • Recruiting
        • Amsterdam University Medical Centers, location AMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan M Coutinho, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suspected acute stroke as per judgement of 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:

- Injuries or infections of the scalp in the area of the electrode headset placement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry electrode StrokePointer EEG
All patients that are included in the study will undergo a dry electrode electroencephalography (EEG).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data quality of StrokePointer
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
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.
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Diagnostic accuracy of StrokePointer for LVO stroke
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Diagnostic accuracy of StrokePointer for LVO stroke among patients with a suspected stroke, as measured with Area under the curve (AUC) as well as sensitivity and specificity
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of StrokePointer in identifying LVO stroke
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Positive and negative predictive value of StrokePointer in identifying LVO stroke
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
User friendliness
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
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.
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Incidence of serious adverse device-related events (Safety of StrokePointer)
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
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.
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Incidence of skin reactions (Safety of StrokePointer)
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Number of patients with an (allergic) skin reaction observed at the site of the electrode.
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Diagnostic accuracy for identifying LVO stroke subgroups
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
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.
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Discriminative power of StrokePointer
Time Frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Discriminative power of StrokePointer for ischemic stroke vs stroke mimic as measured with Area under the curve (AUC) as well as sensitivity and specificity.
EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL85665.000.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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