Continuous mONitoring of recovery iN acutE isChaemic sTroke (CONNECT) - Phase 1

The intervention is for participants to wear the study device (nuroflux) as soon as possible after initial diagnostic imaging (baseline) and for at approximately 24 hours until the completion of their routine Day 1 National Institutes of Health Stroke Scale (NIHSS) assessments and brain scanning, occurring at approximately 24 hours after initial diagnostic imaging are completed. The device will be fitted, checked on, and removed by ED/Stroke ward nurses. A semi-circular ring is fitted across the participant's forehead, held in place by attachments on the sides of the device. In addition, the two ECG electrodes connected to the device are to be applied to upper chest on either side. The device will be worn continuously, and must not be removed or get wet at any point. The device is connected to a laptop wirelessly, which will be set up nearby and checked on by the ED/stroke nurse. The investigational device is intended to provide continuous and objective metrics pertaining to the brain activity and brain blood flow of AIS patients. It is intended to provide an indication of stroke location and severity, patient response to treatment, as well as patient neurological deterioration. Imaging, both initial and follow-up, will be either computerized tomography (CT) or magnetic resonance imaging. CT is most often used, taking a few minutes, and sometimes involving an intravenously administered iodinated contrast agent. MRI is sometimes chosen instead, taking approximately 20 mins, and sometimes utilising an intravenously administered Gadolinium-based contrast agent. The type of imaging, along with the use, specific type of contrast agent, and doses of the contrast agent, are all decisions made by clinicians completely independent from the investigators. Initial imaging, any follow-up imaging taken within 24hrs of baseline, other medical data outside of the device up to 72 hrs after baseline, and the medical data from the 90 day check-up, are all collected as part of the routine hospital diagnostic examination for AIS. While investigators will record this data, we have no influence over these procedures and these procedures not part of the introduced intervention. Aside from wearing the device, the only other active procedure introduced as part of the intervention for the participant will be recording subjective discomfort and adverse effect information in a 24hr diary. If the participant is unable to record this information, a nurse will record this information for them. Within this study, this data will not be viewed in real-time and will not influence the decisions of clinicians. The data will only be viewed by the investigators after the 24hr device use period, comparing it’s measurements to data from other diagnostic measurements collected as a test of its accuracy.