The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available.
EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.
Adults ≥22 years of age
Observable acute neurological deficit suspected to be stroke and within 24 hours of symptom onset
The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient
CT or MRI brain imaging following clinical evaluation per standard of care
Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
In-patient for a neurological condition prior to suspected stroke onset
In-patient in intensive care unit prior to suspected stroke onset
Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
300 subjects across two study arms
Cohort
Cross-sectional
Brain Scan
Diagnostic testThe EMVision emu™ Brain Scanner is a device system which scans the human brain using radiofrequency techniques. The emu™ headset is placed on the head of a patient, enabling ultra-high frequency radio wave (also commonly referred to as microwave) signal propagation into the patient's head. The radio-waves reflect from and transmit through the tissue boundaries and are detected by the receiver antennae within the headset. The transceivers operate at very low-level signals in accordance with national and international safety thresholds. The scattered signals carry information on the scanned tissues.
Demonstrate haemorrhage detection sensitivity >80% and specificity >80%
Demonstrate the time to complete an emu™ Brain Scan is <15 minutes
Evaluate safety of the device
Evaluate usability of the device
Evaluate device deficiencies
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