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

NCT06871969 | Recruiting

• 1 other identifier: NL85665.000.23
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Stroke; Cardiovascular Diseases; Vascular Diseases; Central Nervous System Diseases; Brain Diseases; Nervous System Diseases; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

• Data quality of StrokePointer

  Proportion of patients with a technically successful EEG dataset: at least 20 seconds of usable EEG (at least 3 electrodes with good skin-electrode quality on either side, no movement artifacts, no muscle artifacts) within a measurement time of 3 minutes.

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

• Diagnostic accuracy of StrokePointer for LVO stroke

  Diagnostic accuracy of StrokePointer for LVO stroke among patients with a suspected stroke, as measured with Area under the curve (AUC) as well as sensitivity and specificity

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

Secondary Outcomes (6)

• Predictive value of StrokePointer in identifying LVO stroke

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

• User friendliness

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

• Incidence of serious adverse device-related events (Safety of StrokePointer)

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

• Incidence of skin reactions (Safety of StrokePointer)

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

• Diagnostic accuracy for identifying LVO stroke subgroups

  EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.

Study Arms (1)

Dry electrode StrokePointer EEG

EXPERIMENTAL

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. 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.

Dry electrode StrokePointer EEG

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

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

RECRUITING

MeSH Terms

Conditions

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

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: MD, PhD, neurologist, Principal Investigator

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)