Preventing Secondary Brain Injury by Early Detection of Cerebral Bleeding and Edema

The goal of this project was to 1) improve the Cerebrotech Intracranial Fluid Monitor clinical prototype device design and 2) establish human feasibility through clinical trials. Both objectives have been achieved. The prototype was improved by 1) redesigning the mechanical patient interface, 2) improving the electronics to maximize signal-to-noise ratio, and 3) developing algorithms to correlate the intracranial fluid (ICF) volume measurements to intracranial pressure (ICP) measurements on patients in the ICU (Intensive Care Unit) with severe brain injuries. The study results demonstrate that ICF measurements correlate linearly with ICP in patients exhibiting good intracranial compliance. And, conversely, patients with poor intracranial compliance display a poor correlation of ICF to ICP. These results confirm our original hypothesis based on established neuroscience, and demonstrate the feasibility of non-invasive ICF monitoring using Volumetric Integral Phase-shift Spectroscopy (VIPS) technology. We believe our study was the first to demonstrate the relationship of intracranial fluid volume and pressure using real-time, continuous ICP and ICF measurements in human patients with brain injury. Continued clinical research and validation is warranted.

A proposed research plan for the coming year has been detailed in the March 24, 2014 proposal entitled, "Noninvasive Self-Contained Helmet Intracranial Fluid Monitor." Device iteration and development of a prototype helmet will demonstrate feasibility of a device configuration compatible with use in the International Space Station (ISS). Earth-based clinical validation of the prototype will be performed in association with the Baylor College of Medicine.

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