ACTRN12622001485729
Recruiting
未知
Phase 1 of an investigator-initiated and conducted, multicentre, open-label study to compare the efficacy of the nuroflux device to continuously monitor and detect, abnormal brain function in patients with acute ischaemic stroke from large-vessel occlusion in the anterior circulation of the brain against the gold standard of high-intensity nursing monitoring and routine brain imaging
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The George Institute
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adults (age \>\= 18 years);
- •2\.AIS (initial diagnostic scan within 24 hours from symptom onset or last known well time) in anterior circulation due to large vessel occlusion (LVO, occlusion at the internal carotid artery, the middle cerebral artery horizontal or insular segment, or proximal site of the anterior cerebral artery), diagnosed by clinician and confirmed on CT with/without angiography;
- •3\.At least moderate neurological severity (National Institute of Health Stroke Scale \[NIHSS] score \>4\); and
- •4\.Provision of consent.
Exclusion Criteria
- •1\.Recent (\<1 months) brain surgery;
- •2\.Evidence of seizure activity from stroke symptom onset to study inclusion;
- •3\.Having history of severe skin rash due to ECG/EEG electrode patches;
- •4\.Skin conditions on scalp or face that preclude safe use of the device (local infections, rashes, fragile skin, etc.);
- •5\.Having difficulties to wear the device stably (e.g., patients with severe dementia, extreme agitation, or susceptible to stress).
- •6\. Inability to communicate in English either personally or through translator
Outcomes
Primary Outcomes
Not specified
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