Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06871969

Clinical Evaluation of EEG Device for the Triage of Stroke Patients in the Ambulance

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-10-03

275

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Evaluation of EEG Device for the Triage of Stroke Patients in the Ambulance

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected acute stroke as judged by ambulance personnel
  • Age 18 years or older
  • Onset of symptoms or last seen well less than 24 hours ago
  • Written informed consent by patient or legal representative (deferred)
Not Eligible

You will not qualify if you...

  • Injuries or infections on the scalp where the EEG headset would be placed

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam University Medical Centers, location AMC

Amsterdam, North Holland, Netherlands, 1105AZ

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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