U44NS121555

Noninvasive, wireless thermal sensors for the quantitative monitoring of ventricular shunt function in patients with hydrocephalus - Abstract

Hydrocephalus is a neurological disorder caused by buildup of excess cerebrospinal fluid (CSF) in the brain, and leads to lethargy, seizures, coma, or death. It is treated with the surgical implantation of a catheter, known as a ventricular shunt, that diverts excess CSF away from the brain and into a distal absorptive site, such as the abdomen.

Unfortunately, due to occlusion or mispositioning, shunts have extremely high failure rates - 51% in 2 years, and 98% over 10 years - and often require corrective surgical procedures, known as revisions. 125,000 shunt implantations or revisions are performed annually in the United States, at a cost of $2 billion.

Diagnosing shunt failure is extremely difficult, due the non-specific nature of its symptoms. Imaging tests such as CT are commonly used despite their long-term radiation exposure risks and invasive tests such as CSF aspiration and radionuclide tracing are painful and carry significant infection risks. All the above tests have poor diagnostic performance, with low sensitivities (~80%) and specificities (~55%), in large part because they do not directly measure flow dynamics, arguably the most important and relevant shunt performance metric.

The continuous, non-invasive, real-time monitoring of CSF flow through implanted shunts represents a critical unmet need. Clinicians would use these data for point-of-care diagnostics, and researchers would use them to better understand shunt failure, and elucidate the pathophysiology of poorly-understood conditions such as normal-pressure hydrocephalus.

The present proposal addresses this need by capitalizing on existing wireless sensor hardware to develop the first skin mounted wireless product to give quantitative CSF flow data in implanted shunts. Using precise measurements of thermal transport, we will develop novel algorithms to characterize and quantify flow through underlying shunts with high accuracy. Preliminary patient data, benchtop tests, and computer modeling confirm the ability of the sensor to produce high-quality flow data while being mechanically unobtrusive to the patient.

Phase I activities will validate the sensor on large animal models, develop algorithms to deliver quantitative flow data, and implement a quality management system to govern software development, ultimately leading to IRB approval for clinical testing. Phase II activities will validate diagnostic value of the sensor’s performance clinically through a human trial, ultimately leading to a marketing submission to the FDA.

Rhaeos

(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]

Illinois United States

State-Wide

Translational Neural Devices (U44 - Clinical Trial Required) (RFA-NS-18-012)

Amendment Since initial award the End Date has been extended from 08/31/22 to 08/31/24 and the total obligations have increased 306% from $1,000,000 to $4,059,841.