EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke

NCT03699397 | Completed

• 1 other identifier: NL65939.018.18
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief 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. 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%.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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).

Study Arms (1)

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).

Diagnostic Test: Dry electrode EEG

Interventions

Dry electrode EEG DIAGNOSTIC_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.

Dry electrode cap EEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Injury or active infection of electrode cap placement area.
• STUDY PHASE 2
• 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;
• Written informed consent by patient or legal representative.
• \- Injury or active infection of electrode cap placement area.
• STUDY PHASE 3
• 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).
• \- Injury or active infection of electrode cap placement area.
• STUDY PHASE 4
• Suspected acute ischemic stroke as judged by the attending paramedic;

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam University Medical Centers, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 37848336 DERIVED

• van 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.

  PMID: 36262832 DERIVED

• van 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.

  PMID: 34476587 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jonathan M Coutinho, MD, PhD

  Amsterdam UMC, University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: October 4, 2018
• Primary Completion: June 11, 2022
• Study Completion: March 31, 2023
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)