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Algorithm Development Through AI for the Triage of Stroke Patients in the Ambulance With EEG

NCT05437237 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1192

Last updated 2022-06-29

No results posted yet for this study

Summary

Endovascular thrombectomy (EVT) enormously improves the prognosis of patients with large vessel occlusion (LVO) stroke, but its effect is highly time-dependent. Direct presentation of patients with an LVO stroke to an EVT-capable hospital reduces onset-to-treatment time by 40-115 minutes and thereby improves clinical outcome. Electroencephalography (EEG) may be a suitable prehospital stroke triage instrument for identifying LVO stroke, as differences have been found between EEG recordings of patients with an LVO stroke and those of suspected acute ischemic stroke patients with a smaller or no vessel occlusion. The investigators expect EEG can be performed in less than five minutes in the prehospital setting using a dry electrode EEG cap. An automatic LVO-detection algorithm will be the key to reliable, simple and fast interpretation of EEG recordings by ambulance paramedics. The primary objective of this study is to develop one or more novel AI-based algorithms (the AI-STROKE algorithms) with optimal diagnostic accuracy for identification of LVO stroke in patients with a suspected acute ischemic stroke in the prehospital setting, based on ambulant EEG data.

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. For this purpose the Waveguard touch dry electrode EEG cap and compatible eego mini amplifier (ANT Neuro B.V., Hengelo, Netherlands) are used to record and amplify the EEG signal, respectively. Both products are CE marked as medical devices in the European Union and will be used within the intended use as described in the user manuals.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Jonathan M Coutinho, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-19
Primary Completion
2026-06-30
Completion
2026-06-30

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 NCT05437237 on ClinicalTrials.gov