  This study assessed the safety, feasibility, and acceptability of a novel
device to monitor ischaemic stroke patients. The device captured
electroencephalography (EEG) and electrocardiography (ECG) data to compute an
ECG-based metric termed the Electrocardiography Brain Perfusion index (EBPi),
which may function as a proxy for cerebral blood flow (CBF). Seventeen
ischaemic stroke patients wore the device for nine hours and reported feedback
at 1, 3, 6 and 9 hours regarding user experience, comfort, and satisfaction
(acceptability). Safety was assessed as the number of adverse events reported.
Feasibility was assessed as the percentage of uninterrupted EEG/ECG data
recorded (data capture efficiency). No adverse events were reported, only minor
incidences of discomfort. Overall device comfort (92.5% +/- 10.3%) and data
capture efficiency (95.8% +/- 6.8%) were very high with relatively low
variance. The device did not restrict participants from receiving clinical care
and rarely (n=6) restricted participants from undertaking routine tasks. This
study provides a promising evidence base for the deployment of the device in a
clinical setting. If clinically validated, EBPi may be able to detect CBF
changes to monitor early neurological deterioration and treatment outcomes,
thus filling an important gap in current monitoring options.
