NCT07886957Recruiting
AI-based Algorithm Development for Improved Diagnostics in the Intensive Care and Acute Stroke Setting Using Electroencephalography
AI-based Algorithm Development for Improved Diagnostics in the Intensive Care and Acute Stroke Setting Using Electroencephalography (SMART-EEG)
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
The goal of this observational study is to develop and validate artificial intelligence (AI) algorithms that use subhairline EEG (a simplified EEG patch placed on the forehead and behind the ears) to predict neurological outcome and to detect intracranial hemorrhage. The study consists of two use cases: (UC1) adults (18 years or older) in postanoxic coma after cardiac arrest who are admitted to the intensive care unit (ICU), and UC2) adults with suspected stroke or suspected subarachnoid hemorrhage (SAH) who present to the emergency department. The primary objectives are: * UC1: to develop and validate an AI-algorithm for outcome prediction in postanoxic coma at 24h after CA based on subhairline EEG. * UC2: to develop and validate an AI-algorithm for detection of ICH among patients with (suspected) stroke based on subhairline EEG and clinical symptoms. Participants will: * UC1: receive a continuous subhairline EEG recording, in addition to the standard scalp EEG used in routine care. The recording starts as soon as possible after ICU admission and continues for up to 72 hours after cardiac arrest. * UC2: receive a single subhairline EEG recording of about 2 minutes as soon as possible after arrival. Clinical data is collected from their medical records. This includes patient characteristics, imaging, treatment and outcome at discharge. There are no follow-up visits. In a final pilot phase, up to 10 patients per setting will be measured with the AI algorithms built into the EEG recording device, to evaluate feasibility and user-friendliness. In all phases, EEG and algorithm results are not used for clinical decisions.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 825 (estimated)
- First submitted
- 14 Oct 2026
- Start date
- 26 Mar 2026
- Primary completion date
- 26 Mar 2028
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Stroke
- NCT number
- NCT07886957
What you commit to
- Study type: Observational
- Planned participants: 825
- From 26 Mar 2026 to the primary completion date, 26 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- (Suspected) skin damage or infection at the placement area of the subhairline EEG patch
- \- Other types of severe brain injury, either pre-existing or coinciding with cardiac arrest. These include stroke, traumatic brain injury and progressive neurodegenerative disease.
Other
- All participants:
- Postanoxic coma (ICU):
Who the study is looking for
- All participants:
- \- Age 18 years or older
- Postanoxic coma (ICU):
- Postanoxic coma after cardiac arrest, admitted to the intensive care unit
- No objection to participation within 4 weeks of receiving an opt-out information letter
- Suspected stroke (emergency department):
- Suspected stroke as assessed by the ambulance personnel presenting the patient to the emergency department, or confirmed stroke.
- Symptom onset, or last seen well if onset was not witnessed, less than 24 hours ago.
- Written (deferred) informed consent by the patient or legal representative
- Suspected subarachnoid hemorrhage (emergency department):
- Suspected subarachnoid hemorrhage as judged by the attending ambulance paramedic, or confirmed subarachnoid hemorrhage.
- Symptom onset, or last seen well if onset was not witnessed, less than 48 hours ago.
- Written (deferred) informed consent by the patient or legal representative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.