Portable EEG to triage suspected stroke patients in ambulances
Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography
This trial will test whether a portable dry‑electrode EEG headset (StrokePointer) can detect large vessel occlusion strokes in adults with suspected acute stroke so ambulance crews can take them directly to hospitals that perform thrombectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06871969 on ClinicalTrials.gov |
What this trial studies
The study will deploy a portable dry‑electrode EEG device (StrokePointer) in the prehospital ambulance setting to record brain signals from adults with suspected acute stroke and analyze those signals on site. Recordings will be attempted within 24 hours of symptom onset and interpreted by the device algorithm, with device results compared to hospital imaging and final clinical diagnosis to determine accuracy. The trial aims to demonstrate that the device can produce analyzable EEG in >85% of patients and achieve diagnostic accuracy for LVO detection with an AUC >0.8. Safety and feasibility of using the headset in the ambulance and consent procedures (including deferred consent) are also assessed at a single academic center.
Who should consider this trial
Good fit: Adults aged 18 or older with suspected acute stroke identified by ambulance personnel within 24 hours of symptom onset (or last seen well) who can provide informed or deferred consent are the intended participants.
Not a fit: Patients with scalp injuries or infections at the headset site, those with very poor EEG signal quality, or patients with stroke onset beyond 24 hours are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could let ambulance crews identify likely LVO strokes earlier and route patients directly to thrombectomy centers, shortening time-to-treatment and potentially improving outcomes.
How similar studies have performed: Previous dry‑electrode EEG approaches have shown promising diagnostic accuracy for LVO detection (reported AUC ≈ 0.91) but experienced poor signal quality in about one‑third of patients, so the approach is promising but needs validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: \- Injuries or infections of the scalp in the area of the electrode headset placement.
Where this trial is running
Amsterdam, North Holland
- Amsterdam University Medical Centers, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.