EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit (Stage 2)

This trial is the second stage of a two stage study for the development of the pre-hospital EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit (MSU). The stage expects to enrol a total of 80 participants, pending sample size determination following the first stage of the study. This study aims to evaluate EMVision First Responder Brain Scan data compared with acute radiological imaging. Participants receiving a CT scan on the MSU suspected of suffering from a suspected stroke will receive an EMVision First Responder brain scan. This brain scan measures the dielectric properties of the brain using non-invasive, non-ionising, low-energy, electromagnetic pulses. During an EMVision First Responder brain scan procedure, the EMVision First Responder Brain Scanner is brought to a participant lying supine on a comfortable flat surface (i.e., stretcher, bed). A headset housing an array of antennae is placed on the head, where the headset membrane inflates with a coupling fluid to conform to the shape of the head during which the scans take place. Participation in this study consists of a single visit taking place at the scene of MSU attendance and consists of a single brief scan procedure (typically under six minutes) conducted by a qualified physician, nurse or paramedic. Study participation is considered complete upon the conclusion of the brain scan. No additional study procedures are required of the participant following the initial brain scan. Standard-of-care radiological imaging from the MSU and the destination hospital (if applicable) is collected. Personnel responsible for conducting scans will receive two hours of face-to-face training with EMVision trainers approximately one week prior to enrolment of the first participant. All scan data is reviewed by EMVision engineers to verify scanning procedures are conducted to an appropriate standard.