No registrations found.
ID
Source
Brief title
Health condition
Acute ischemic stroke
Sponsors and support
Intervention
Outcome measures
Primary outcome
Co-primary end points: sensitivity and specificity of EEG for diagnosis of LVO-a in suspected AIS patients;
Secondary outcome
Developing novel algorithms with optimal diagnostic accuracy for LVO-a detection with EEG;
Positive predictive value (PPV) and negative predictive value (NPV) of EEG for diagnosis of LVO-a in suspected AIS patients;
Technical and logistical feasibility of performing EEGs on patients with a suspected AIS;
Background summary
Stroke is a sudden interruption in the blood supply of the brain. Stroke is the most frequent cause of long-term disability and the third most frequent cause of death in developed countries. Because of the aging population in Europe, annual incidence of stroke is expected to increase from 1.1 million in 2000 to 1.5 million in 2025. In 2015 care for stroke patients worldwide underwent a revolution with the introduction of a new therapy; endovascular thrombectomy (EVT). EVT is now standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT can be performed in selected hospitals only. Currently, approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy. Therefore, an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary. Electroencephalography (EEG) may be suitable for this purpose, as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging. Combined with algorithms for automated signal analysis, we expect the time of EEG recording and analysis to eventually be below five minutes, which would make stroke triage in the ambulance by EEG logistically feasible.
Study objective
The goal of EEG4STROKE is to test a device that enables paramedics to accurately diagnose patients with suspected stroke on site (in the ambulance or living room of the patient). EEG4STROKE will integrate hardware and software to triage stroke patients. Early triage enables earlier hospital selection and faster treatment, which will drastically improve patient’s chance of recovery.
Study design
1
Intervention
EEG
Inclusion criteria
- Suspected acute ischemic stroke, as judged by the paramedic presenting the patient to the ER or known AIS with an LVO-a;
- Onset of symptoms or, if onset was not witnessed, last seen well <24 hours ago;
- Age of 18 years or older;
- Written informed consent by patient or legal representative (deferred).
Exclusion criteria
- Injury or active infection of electrode cap placement area;
- SARS-COV-2 infection (confirmed or suspected).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9765 |
| Other | METC AMC : METC2020_304 |