Prospective comparative clinical trials of novel non-invasive intracranial pressure pulse wave monitoring technologies: preliminary clinical data

Abstract

Intracranial pressure (ICP) monitoring is crucial in the management of traumatic brain injury (TBI) and other neurological conditions. Elevated ICP or too low intracranial compliance (ICC) can compromise brain perfusion. Simultaneous monitoring of ICP and ICC is needed to optimize patient-specific brain perfusion in pathological conditions. Surrogate ICC changes can be extracted by analysis of ICP pulse wave morphology. Non-invasive, fully passive sensor and ICC changes monitoring are needed. This study introduces Archimedes, a novel, fully passive, non-invasive ICP wave monitor that utilizes mechanical pulsatile movement of the eyeball to assess ICP pulse waveforms. Preliminary findings indicate a high correlation r = [0.919; 0.96] between non-invasive and invasive ICP pulse wave morphologies, demonstrating the device’s potential for accurate ICP pulse waveform monitoring. Additionally, the monitor can discern ICC changes, providing valuable insights for TBI and normal tension glaucoma patients according to the shape of non-invasive measured ICP pulse wave. The k-nearest neighbours algorithm used in preliminary glaucoma studies yielded promising diagnostic performance, with an accuracy of 0.89, sensitivity of 0.82, specificity of 1.0 and area under curve 0.91. Ethical approvals for ongoing studies have been secured. Initial results indicate that Archimedes real-time ICC non-invasive monitor is safe, cost-effective alternative to conventional monitoring techniques.