An Early Feasibility Study to Obtain Imaging Data from Participants with a Diagnosed Stroke to Refine the Algorithm for the EMVision Brain Scanner

Once consent is documented, the participant would be further reviewed, and data such as demographics, medical history, vital signs, and NIH Stroke Scale will be collected, and physical exam will be performed. Physical exam, NIH Stroke Scale and vital signs be recorded and are part of triage process or hospital/emergency department acute care standard operating procedure. CT/MRI would be conducted as part of standard diagnostics process of any patients presenting with stroke symptoms. Stroke diagnosis would be made following the results of CT/MRI and whether of haemorrhagic stroke or ischemic stroke will be collected and recorded. The EMV scanner unit consists of a portable headset (a crown housing an array of antennae, with a coupling-fluid filled bladder that inflates gently to make contact with the head), and computer with graphic user interface. Within 72 hour, and ideally as close to the diagnostic scan time as feasible, the EMVision brain scanner will be placed on the participant’s head to acquire the first scan data. Each image acquisition from positioning, scanning and device removal will take approximately 10 minutes. Scanning will be undertaken by a member of the Neurology and/or Intensivist team after extensive training is undertaken and signed off by the Sponsor. Actual image acquisition will take approximately 20 seconds. The participants will be positioned in a semi-recumbent position in the bed for scanning. A pillow will be placed behind the participant’s back to accommodate the head scanner such that the participant is kept as comfortable as possible during the scan. Each EMVision scan will be performed in duplicate, user/performance data will be gathered, and image data recorded from both scans will be analysed for reproducibility/comparison. The participants would be exposed to signal power intensities up to 10 mW which is within Federal Communications Commission standards. These frequencies are used in mobile communication, body scanners and many other daily life applications. The captured signals are then stored and processed using a laptop or tablet and subsequently analysed at the UQ ITT laboratory to generate an image of the head. Follow up scans as above will be collected at approximately days 3-5, 6-8, and during the convalescence period, if clinically acceptable to do so, as deemed by the investigator. No more than five scans will be collected. A participant’s involvement may last up to approximately 28 days as an inpatient or until discharge (whichever is sooner). A patient may be considered as 'completed' if a minimum of one EMVision digital can is conducted and is either followed to 28 days (or discharge, whichever is sooner) or passes away prior.