RecruitingNot ApplicableNCT06871969

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

Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography


Sponsor

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

Enrollment

275 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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).

Exclusion Criteria1

  • \- Injuries or infections of the scalp in the area of the electrode headset placement.

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Interventions

DIAGNOSTIC_TESTDry electrode EEG

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.


Locations(1)

Amsterdam University Medical Centers, location AMC

Amsterdam, North Holland, Netherlands

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NCT06871969


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