UG3NS123191

Minimally Invasive Cerebral Blood Flow and Oxygenation Monitoring for Intracranial Hypertension - Abstract/Project Summary

Traumatic brain injury, acute ischemic stroke, and intracerebral hemorrhage are frequently complicated by intracranial hypertension, leading to progressive ischemia and secondary brain injury. Recent efforts focused on improving outcomes have therefore been focused upon improving cerebral oxygenation and the development of monitoring devices to guide therapy.

Current devices designed to measure tissue oxygenation are, however, severely limited in their scope of surveillance and accuracy. Surface oximetry monitors interrogate only superficial brain tissue, with contamination from intervening skin and skull. Intraparenchymal brain tissue oxygen probes survey relatively metabolically less active white matter (compared to gray matter), a volume of less than 3 mm3, and at a single location. Lastly, intraparenchymal tissue oxygen monitors are bulky, incompatible with magnetic resonance imaging, and have yet to demonstrate clinical efficacy.

To fill this need, we will finalize the development of a brain-specific, minimally invasive, optical blood flow and oxygenation monitoring system (FLOXBR), then translate this device to humans. The FLOXBR, employing diffuse optical and correlation spectroscopies via a brain surface probe, may offer improved sensitivity and specificity compared to non-invasive probes and will probe larger volumes than currently available invasive probes, such as the LICOXTM tissue PO2 probe. Unlike intraparenchymal probes, this device can lie above or below the dura and will be more sensitive to highly metabolically active gray matter. Its small size and flexibility will permit multiple probes to be placed through a single burr hole, thus allowing for the monitoring of regional differences in flow and oxygenation. Unlike surface oximetry, the FLOXBR is not impacted by superficial trauma or edema, improving reliability and sensitivity.

Continuous, easily interpreted, and reliable minimally invasive monitoring of cerebral oxygen delivery may enhance management and outcomes in patients suffering from intracranial hypertension. Our aims are succinctly summarized below.

Aim 1) Finalize development and manufacture the FLOXBR brain flow and oximetry monitoring device.

Aim 2) Pre-clinical device evaluation, measurement validation, and safety testing of FLOXBR.

Aim 3) Complete regulatory and safety requirements to support FLOXBR first-in-humans feasibility testing.

Aim 4) Conduct first-in-humans feasibility testing.

Rector & Visitors Of The University Of Virginia

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Charlottesville, Virginia 229034833 United States

Single Zip Code

Translational Neural Devices (UG3/UH3 - Clinical Trial Optional) (RFA-NS-21-021)

Amendment Since initial award the End Date has been extended from 08/31/25 to 05/31/26 and the total obligations have increased 213% from $1,814,829 to $5,676,801.