Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Netherlands
Amsterdam University Medical Centers, location AMC
RECRUITING
Amsterdam
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 275
Treatments
Experimental: Dry electrode StrokePointer EEG
All patients that are included in the study will undergo a dry electrode electroencephalography (EEG).
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov