Phase 2 of an investigator-initiated and conducted, multicenter, 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

The George Institute0 个研究点目标入组 260 人开始时间: 2022年11月28日最近更新: 2024年1月15日

试验速览

暂无简介。

•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.

•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

发起方