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.

There is a glaring gap in diagnosing and monitoring patients for brain edema and bleeding. At most, CT (computed tomography) and MRI (magnetic resonance imaging) only provide daily snapshots, and other probes like intracranial pressure (ICP) monitors are extremely invasive and are only used in the most serious cases. Most patients are left largely unmonitored in their hospital beds, except for periodic subjective clinical neurological exams, leaving them exposed to a risk of undetected brain edema or bleeding, until it causes a significant and detectable neurological deficit—and by then it is too late. Cerebrotech will offer a completely noninvasive device for monitoring small changes in brain edema and bleeding, which will provide a continuous and objective measure of brain fluids and ischemia at the patient's bedside. Patients include over 3 million admitted each year worldwide for stroke, traumatic brain injury, brain surgery, and other disorders that place them at high risk for clinical degradation. Early detection of adverse changes in patient condition is the key to improving outcomes and reducing cost for hospitals and payers.

This is early/mid-stage (TRL 6) — the most realistic path in is NASA SBIR/STTR, which funds small businesses and research institutions to develop technology aligned with NASA's needs (equity-free, phased funding). Check whether a current SBIR/STTR solicitation topic overlaps with this project's technology area, or contact the project directly (above) to ask.

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