Ischemic StrokeCROSSROADS-EEGNCT06871969
Clinical Evaluation of EEG Device for the Triage of Stroke Patients in the Ambulance
A study testing Dry electrode EEG in people with Ischemic Stroke and Stroke, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Stroke, Cardiovascular Diseases
- What is being tested?
- Dry electrode EEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Injuries or infections of the scalp in the area of the electrode headset placement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Centers, location AMC
Amsterdam, North Holland, 1105AZ
Maud BRC Eurlings, MD, 0031 20 566 9111, m.b.r.c.eurlings@amsterdamumc.nl
Jonathan M Coutinho, MD, PhD, 0031 20 566 9111, j.coutinho@amsterdamumc.nl
About this study
Official title: 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.
Read the 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:
- 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.
- Usability of StrokePointer device is rated as "good" on average by ambulance personnel.
- 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.
- Conditions
- Ischemic Stroke, Stroke, Cardiovascular Diseases, Vascular Diseases, Central Nervous System Diseases, Brain Diseases
- Being tested
- Dry electrode EEG
- Medical subject headings
- Ischemic Stroke, Stroke, Cardiovascular Diseases, Vascular Diseases, Central Nervous System Diseases, Brain Diseases, Nervous System Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry electrode EEGDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry electrode StrokePointer EEG | Experimental | All patients that are included in the study will undergo a dry electrode electroencephalography (EEG). Receives: Diagnostic Test: Dry electrode EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data quality of StrokePointer
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.
Measured: 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
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
Measured: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Secondary outcomes (6)
Predictive value of StrokePointer in identifying LVO stroke
Positive and negative predictive value of StrokePointer in identifying LVO stroke
Measured: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
User friendliness
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.
Measured: 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)
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.
Measured: 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)
Number of patients with an (allergic) skin reaction observed at the site of the electrode.
Measured: 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
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.
Measured: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Discriminative power of StrokePointer
Discriminative power of StrokePointer for ischemic stroke vs stroke mimic as measured with Area under the curve (AUC) as well as sensitivity and specificity.
Measured: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Coutinho, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871969
- Sponsor's protocol ID
- NL85665.000.23
- Acronym
- CROSSROADS-EEG
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography
- ClinicalTrials.gov ID
- NCT06871969
- Acronym / sponsor ID
- CROSSROADS-EEG / NL85665.000.23
- Conditions
- Ischemic Stroke, Stroke, Cardiovascular Diseases, Vascular Diseases, Central Nervous System Diseases, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Usability of StrokePointer device is rated as "good" on average by ambulance personnel.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry electrode StrokePointer EEG | Experimental | Diagnostic Test: Dry electrode EEGAll patients that are included in the study will undergo a dry electrode electroencephalography (EEG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Injuries or infections of the scalp in the area of the electrode headset placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry electrode EEGA 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. | Diagnostic test | Dry electrode StrokePointer EEG |
Primary outcome
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.
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
6 secondary outcomes
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.
User friendliness
Time frame: 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.
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.
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.
Discriminative power of StrokePointer
Time frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amsterdam University Medical Centers, location AMC
Amsterdam, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry electrode EEG in people with Ischemic Stroke and Stroke, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data quality of StrokePointer (time frame: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.