Stroke, IschemicELECTRA-STROKENCT03699397
EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke
A study testing Dry electrode EEG in people with Stroke, Ischemic, 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 patients with a large vessel occlusion (LVO) stroke. Direct presentation of patients with an LVO to a comprehensive stroke center (CSC) reduces onset-to-treatment time by approximately an hour and thereby improves clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Dry electrode EEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Oct 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age of 18 years or older;
- Patient is in the outpatient clinic of the Clinical Neurophysiology department of the AMC, because a regular EEG has been/will be performed on him/her for standard medical care;
- Written informed consent by patient.
- A diagnosis of acute ischemic stroke caused by a large vessel occlusion in the anterior circulation (intracranial carotid artery or proximal (M1/M2) middle cerebral artery confirmed by neuro-imaging (CTA or MRA);
- Stroke onset <72 hours before expected time of performing EEG;
- Age of 18 years or older;
Show all 15Show fewer
- Written informed consent by patient or legal representative.
- Suspected acute ischemic stroke, as judged by the paramedic presenting the patient to the ER or known AIS with an LVO-a;
- Onset of symptoms or, if onset was not witnessed, last seen well <24 hours ago;
- Age of 18 years or older;
- Written informed consent by patient or legal representative (deferred).
- Suspected acute ischemic stroke as judged by the attending paramedic;
- Onset of symptoms or, if onset not witnessed, last seen well <24 hours ago;
- Age of 18 years or older;
- Written informed consent by patient or legal representative (deferred).
Who cannot join
- Injury or active infection of electrode cap placement area.
- STUDY PHASE 2
- Injury or active infection of electrode cap placement area.
- STUDY PHASE 3
- Injury or active infection of electrode cap placement area.
- STUDY PHASE 4
- Injury or active infection of electrode cap placement area.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam University Medical Centers, location AMC
Amsterdam, North Holland, 1105AZ
About this study
Endovascular thrombectomy (EVT) is the standard treatment for patients with a large vessel occlusion (LVO) stroke. Direct presentation of patients with an LVO to a comprehensive stroke center (CSC) reduces onset-to-treatment time by approximately an hour and thereby improves clinical outcome. However, a reliable tool for prehospital LVO-detection is currently not available. Previous electroencephalography (EEG) studies have shown that hemispheric hypoxia quickly results in slowing of the EEG-signal. Dry electrode EEG caps allow reliable EEG measurement in less than five minutes. We hypothesize that dry electrode EEG is an accurate and feasible diagnostic test for LVO in the prehospital setting.
ELECTRA-STROKE is a diagnostic pilot study that consists of four phases. In phases 1, 2 and 3, technical and logistical feasibility of performing dry electrode EEGs are tested in different in-hospital settings: the outpatient clinic (sample size: max. 20 patients), Neurology ward (sample size: max. 20 patients) and emergency room (sample size: max. 300 patients), respectively. In the final phase, ambulance paramedics will perform dry electrode EEGs in 386 patients with a suspected stroke. The aim of the ELECTRA-STROKE study is to determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS. Sample size calculation is based on an expected specificity of 70% and an incidence of LVO stroke of 5%.
Read the detailed description
RATIONALE
Endovascular thrombectomy (EVT) is standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT is performed in selected hospitals only. Currently, approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy. This delays initiation of treatment by approximately an hour, which decreases the chance of a good clinical outcome. Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible, since only approximately 7% of these patients are eligible for EVT. Therefore, an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary. Electroencephalography (EEG) may be suitable for this purpose, as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging. Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with 'wet' EEGs. Combined with algorithms for automated signal analysis, we expect the time of EEG recording and analysis to eventually be below five minutes, which would make stroke triage in the ambulance by EEG logistically feasible.
HYPOTHESIS
We hypothesize that EEG accurately identifies the presence of an LVO-a stroke in patients with a suspected AIS when applied in the ambulance.
OBJECTIVE
To determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS.
STUDY DESIGN
This diagnostic study consists of four phases:
Phase 1: Optimization of measurement time and software settings of the dry electrode cap EEG in a non-emergency setting in patients in whom a regular EEG is/will be performed for standard medical care. Sample size: maximum of 20 patients.
Phase 2: Optimization of measurement time and software settings of the dry electrode cap EEG in patients close to our target population in a non-emergency setting. Sample size: maximum of 20 patients.
Phase 3: Validation of several existing algorithms and development of one or more new algorithms for LVO-a detection, as well as optimization of logistics and software settings of the dry electrode EEG cap in patients close to our target population in an in-hospital emergency setting. Sample size: maximum of 300 patients.
Phase 4: Validation of several existing algorithms and algorithms developed in phase 3 for LVO-a detection in patients with a suspected AIS in the ambulance, as well as assessment of technical and logistical feasibility of performing EEG with dry electrode caps in patients with a suspected AIS in the ambulance. Sample size: maximum of 386 patients.
STUDY POPULATION
Phase 1: Patients in the outpatient clinic of the Clinical Neurophysiology department of the AMC, in whom a regular EEG has been/will be performed for standard medical care.
Phase 2: Patients with an AIS admitted to the Neurology ward of the coordinating hospital with an LVO-a (after reperfusion therapy).
Phase 3: Patients with a suspected AIS in the emergency room (ER) of the coordinating hospital (before endovascular treatment).
Phase 4: Patients with a suspected AIS in the ambulance.
INTERVENTION
Performing a dry electrode cap EEG (in phase 1 in the outpatient clinic, in phase 2 during hospital admission, in phase 3 in the ER and in phase 4 in the ambulance).
MAIN END POINTS
Primary end point: the diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting (study phase 4) expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
Secondary end points:
- Sensitivity, specificity, PPV and NPV of the theta/alpha ratio, and test characteristics of other existing EEG data based algorithms for LVO-a detection (e.g. Weighted Phase Lag Index, delta/alpha ratio);
- Logistical and technical feasibility of paramedics performing dry electrode cap EEG in the ambulance in suspected AIS patients;
- Developing one or more novel EEG data based algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG.
- Conditions
- Stroke, Ischemic
- Being tested
- Dry electrode EEG
- Medical subject headings
- Ischemic Stroke
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. To do this, the investigators will use the WaveguardTM dry electrode EEG cap and compatible eegoTM amplifier, developed by ANT Neuro B.V. Netherlands and both CE marked as medical devices in the European Union (see appendices 1 and 2). Both products will be used within the intended use as described in the user manuals. The dry electrode cap is put on the patients head and records the EEG signal for several minutes; the amplifier is used to amplify the EEG signal and reduce artefacts.
| Study group | Role | What they receive |
|---|---|---|
| Dry electrode cap EEG | Experimental | In this diagnostic accuracy study, 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.
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke in the prehospital setting expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting (study phase 4) expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
Measured: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Secondary outcomes (7)
Sensitivity of dry electrode EEG for diagnosis of LVO-a
Sensitivity of the theta/alpha ratio, and test characteristics of other existing EEG data based algorithms for LVO-a detection (e.g. Weighted Phase Lag Index, delta/alpha ratio).
Measured: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Specificity of dry electrode EEG for diagnosis of LVO-a
Specificity of the theta/alpha ratio, and test characteristics of other existing EEG data based algorithms for LVO-a detection (e.g. Weighted Phase Lag Index, delta/alpha ratio).
Measured: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Positive predictive value of dry electrode EEG for diagnosis of LVO-a
Positive predictive value of the theta/alpha ratio, and test characteristics of other existing EEG data based algorithms for LVO-a detection (e.g. Weighted Phase Lag Index, delta/alpha ratio).
Measured: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Negative predictive value of dry electrode EEG for diagnosis of LVO-a
Negative predictive value of the theta/alpha ratio, and test characteristics of other existing EEG data based algorithms for LVO-a detection (e.g. Weighted Phase Lag Index, delta/alpha ratio).
Measured: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Technical feasibility of performing dry electrode EEGs in the ambulance
Technical feasibility of performing dry electrode cap EEGs on patients with a suspected acute ischemic stroke in the ambulance
Measured: Feedback on technical issues by the paramedic that performs the EEG and by the EEG-expert, will be collected directly at arrival in the emergency department (within 24 hours after the patient is included in the study).
Logistical feasibility of performing dry electrode EEGs in the ambulance
Logistical feasibility of performing dry electrode cap EEGs on patients with a suspected acute ischemic stroke in the ambulance
Measured: Feedback on logistical issues by the paramedic that performs the EEG, will be collected directly at arrival in the emergency department (within 24 hours after the patient is included in the study).
Algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG.
Developing one or more novel EEG data based algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG.
Measured: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start4 Oct 2018
- Primary completion11 Jun 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- 386 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Coutinho, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jonathan M Coutinho, MD, PhD, Principal investigator, Amsterdam UMC, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699397
- Sponsor's protocol ID
- NL65939.018.18
- Acronym
- ELECTRA-STROKE
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2018
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Stigt MN, Groenendijk EA, van Meenen LCC, van de Munckhof AAGA, Theunissen M, Franschman G, Smeekes MD, van Grondelle JAF, Geuzebroek G, Siegers A, Visser MC, van Schaik SM, Halkes PHA, Majoie CBLM, Roos YBWEM, Koelman JHTM, Koopman MS, Marquering HA, Potters WV, Coutinho JM. Prehospital Detection of Large Vessel Occlusion Stroke With EEG. Neurology. 2023 Dec 12;101(24):e2522-e2532. doi: 10.1212/WNL.0000000000207831. Epub 2023 Oct 17.
PubMed 37848336van Stigt MN, van de Munckhof AAGA, van Meenen LCC, Groenendijk EA, Theunissen M, Franschman G, Smeekes MD, van Grondelle JAF, Geuzebroek G, Siegers A, Marquering HA, Majoie CBLM, Roos YBWEM, Koelman JHTM, Potters WV, Coutinho JM. ELECTRA-STROKE: Electroencephalography controlled triage in the ambulance for acute ischemic stroke-Study protocol for a diagnostic trial. Front Neurol. 2022 Oct 3;13:1018493. doi: 10.3389/fneur.2022.1018493. eCollection 2022.
PubMed 36262832van Meenen LCC, van Stigt MN, Marquering HA, Majoie CBLM, Roos YBWEM, Koelman JHTM, Potters WV, Coutinho JM. Detection of large vessel occlusion stroke with electroencephalography in the emergency room: first results of the ELECTRA-STROKE study. J Neurol. 2022 Apr;269(4):2030-2038. doi: 10.1007/s00415-021-10781-6. Epub 2021 Sep 2.
PubMed 34476587
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03699397
- Acronym / sponsor ID
- ELECTRA-STROKE / NL65939.018.18
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 9 Oct 2018 (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 patients with a large vessel occlusion (LVO) stroke. Direct presentation of patients with an LVO to a comprehensive stroke center (CSC) reduces onset-to-treatment time by approximately an hour and thereby improves clinical outcome. However, a reliable tool for prehospital LVO-detection is currently not available. Previous electroencephalography (EEG) studies have shown that hemispheric hypoxia quickly results in slowing of the EEG-signal. Dry electrode EEG caps allow reliable EEG measurement in less than five minutes. We hypothesize that dry electrode EEG is an accurate and feasible diagnostic test for LVO in the prehospital setting.
ELECTRA-STROKE is a diagnostic pilot study that consists of four phases. In phases 1, 2 and 3, technical and logistical feasibility of performing dry electrode EEGs are tested in different in-hospital settings: the outpatient clinic (sample size: max. 20 patients), Neurology ward (sample size: max. 20 patients) and emergency room (sample size: max. 300 patients), respectively. In the final phase, ambulance paramedics will perform dry electrode EEGs in 386 patients with a suspected stroke. The aim of the ELECTRA-STROKE study is to determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS. Sample size calculation is based on an expected specificity of 70% and an incidence of LVO stroke of 5%.
Detailed description
RATIONALE
Endovascular thrombectomy (EVT) is standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT is performed in selected hospitals only. Currently, approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy. This delays initiation of treatment by approximately an hour, which decreases the chance of a good clinical outcome. Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible, since only approximately 7% of these patients are eligible for EVT. Therefore, an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary. Electroencephalography (EEG) may be suitable for this purpose, as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging. Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with 'wet' EEGs. Combined with algorithms for automated signal analysis, we expect the time of EEG recording and analysis to eventually be below five minutes, which would make stroke triage in the ambulance by EEG logistically feasible.
HYPOTHESIS
We hypothesize that EEG accurately identifies the presence of an LVO-a stroke in patients with a suspected AIS when applied in the ambulance.
OBJECTIVE
To determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS.
STUDY DESIGN
This diagnostic study consists of four phases:
Phase 1: Optimization of measurement time and software settings of the dry electrode cap EEG in a non-emergency setting in patients in whom a regular EEG is/will be performed for standard medical care. Sample size: maximum of 20 patients.
Phase 2: Optimization of measurement time and software settings of the dry electrode cap EEG in patients close to our target population in a non-emergency setting. Sample size: maximum of 20 patients.
Phase 3: Validation of several existing algorithms and development of one or more new algorithms for LVO-a detection, as well as optimization of logistics and software settings of the dry electrode EEG cap in patients close to our target population in an in-hospital emergency setting. Sample size: maximum of 300 patients.
Phase 4: Validation of several existing algorithms and algorithms developed in phase 3 for LVO-a detection in patients with a suspected AIS in the ambulance, as well as assessment of technical and logistical feasibility of performing EEG with dry electrode caps in patients with a suspected AIS in the ambulance. Sample size: maximum of 386 patients.
STUDY POPULATION
Phase 1: Patients in the outpatient clinic of the Clinical Neurophysiology department of the AMC, in whom a regular EEG has been/will be performed for standard medical care.
Phase 2: Patients with an AIS admitted to the Neurology ward of the coordinating hospital with an LVO-a (after reperfusion therapy).
Phase 3: Patients with a suspected AIS in the emergency room (ER) of the coordinating hospital (before endovascular treatment).
Phase 4: Patients with a suspected AIS in the ambulance.
INTERVENTION
Performing a dry electrode cap EEG (in phase 1 in the outpatient clinic, in phase 2 during hospital admission, in phase 3 in the ER and in phase 4 in the ambulance).
MAIN END POINTS
Primary end point: the diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting (study phase 4) expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
Secondary end points:
- Sensitivity, specificity, PPV and NPV of the theta/alpha ratio, and test characteristics of other existing EEG data based algorithms for LVO-a detection (e.g. Weighted Phase Lag Index, delta/alpha ratio);
- Logistical and technical feasibility of paramedics performing dry electrode cap EEG in the ambulance in suspected AIS patients;
- Developing one or more novel EEG data based algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG.
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 cap EEG | Experimental | Diagnostic Test: Dry electrode EEGIn this diagnostic accuracy study, all 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 (15 listed)
- Age of 18 years or older;
- Patient is in the outpatient clinic of the Clinical Neurophysiology department of the AMC, because a regular EEG has been/will be performed on him/her for standard medical care;
- Written informed consent by patient.
- A diagnosis of acute ischemic stroke caused by a large vessel occlusion in the anterior circulation (intracranial carotid artery or proximal (M1/M2) middle cerebral artery confirmed by neuro-imaging (CTA or MRA);
- Stroke onset <72 hours before expected time of performing EEG;
Key exclusion criteria (7 listed)
- Injury or active infection of electrode cap placement area.
- STUDY PHASE 2
- Injury or active infection of electrode cap placement area.
- STUDY PHASE 3
- Injury or active infection of electrode cap placement area.
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. To do this, the investigators will use the WaveguardTM dry electrode EEG cap and compatible eegoTM amplifier, developed by ANT Neuro B.V. Netherlands and both CE marked as medical devices in the European Union (see appendices 1 and 2). Both products will be used within the intended use as described in the user manuals. The dry electrode cap is put on the patients head and records the EEG signal for several minutes; the amplifier is used to amplify the EEG signal and reduce artefacts. | Diagnostic test | Dry electrode cap EEG |
Primary outcome
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke in the prehospital setting expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
Time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting (study phase 4) expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
7 secondary outcomes
Sensitivity of dry electrode EEG for diagnosis of LVO-a
Time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Specificity of dry electrode EEG for diagnosis of LVO-a
Time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Positive predictive value of dry electrode EEG for diagnosis of LVO-a
Time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Negative predictive value of dry electrode EEG for diagnosis of LVO-a
Time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Technical feasibility of performing dry electrode EEGs in the ambulance
Time frame: Feedback on technical issues by the paramedic that performs the EEG and by the EEG-expert, will be collected directly at arrival in the emergency department (within 24 hours after the patient is included in the study).
Logistical feasibility of performing dry electrode EEGs in the ambulance
Time frame: Feedback on logistical issues by the paramedic that performs the EEG, will be collected directly at arrival in the emergency department (within 24 hours after the patient is included in the study).
Algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG.
Time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 37848336van Stigt MN, Groenendijk EA, van Meenen LCC, van de Munckhof AAGA, Theunissen M, Franschman G, Smeekes MD, van Grondelle JAF, Geuzebroek G, Siegers A, Visser MC, van Schaik SM, Halkes PHA, Majoie CBLM, Roos YBWEM, Koelman JHTM, Koopman MS, Marquering HA, Potters WV, Coutinho JM. Prehospital Detection of Large Vessel Occlusion Stroke With EEG. Neurology. 2023 Dec 12;101(24):e2522-e2532. doi: 10.1212/WNL.0000000000207831. Epub 2023 Oct 17.
- Derived from this study: PubMed 36262832van Stigt MN, van de Munckhof AAGA, van Meenen LCC, Groenendijk EA, Theunissen M, Franschman G, Smeekes MD, van Grondelle JAF, Geuzebroek G, Siegers A, Marquering HA, Majoie CBLM, Roos YBWEM, Koelman JHTM, Potters WV, Coutinho JM. ELECTRA-STROKE: Electroencephalography controlled triage in the ambulance for acute ischemic stroke-Study protocol for a diagnostic trial. Front Neurol. 2022 Oct 3;13:1018493. doi: 10.3389/fneur.2022.1018493. eCollection 2022.
- Derived from this study: PubMed 34476587van Meenen LCC, van Stigt MN, Marquering HA, Majoie CBLM, Roos YBWEM, Koelman JHTM, Potters WV, Coutinho JM. Detection of large vessel occlusion stroke with electroencephalography in the emergency room: first results of the ELECTRA-STROKE study. J Neurol. 2022 Apr;269(4):2030-2038. doi: 10.1007/s00415-021-10781-6. Epub 2021 Sep 2.
- 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. This study is not recruiting at the moment.
Jonathan M Coutinho, MD, PhD principal investigator
Amsterdam UMC, University of Amsterdam
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 Stroke, Ischemic, 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 15 inclusion and 7 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: finished, as of the sponsor's last update on 11 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke in the prehospital setting expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio. (time frame: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699397, which also lists 3 linked publications.
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 11 Apr 2025.