Automated Smart Nerve Stimulator to Assess Neuromechanical Function in Veterans

About This Grant

ABSTRACT Significance to VA: Knee osteoarthritis is a major health problem in Veterans and accounts for approximately one-half of all joint replacement surgeries in the VA system. Total knee arthroplasty is the current standard of care to treat advanced knee osteoarthritis and is effective in reducing pain. However, nearly 1 in 4 patients report not being satisfied with their surgery. While the reasons for this high number of unsatisfied patients is multifactorial, poor knee function is a major driver behind poor outcomes. Clinical research studies often characterize functional deficits by evaluating Arthrogenic Muscle Inhibition (AMI). But these evaluations typically require the patient to maximally contract their muscles, which often causes pain and leads to unreliable results. Additionally, specialized equipment and highly trained investigators are essential for reliable measurements. Innovation and Impact: This project addresses these challenges in quantifying AMI by developing, validating, and implementing a novel nerve stimulating platform called the Smart Nerve Stimulator to quantify Arthrogenic Muscle Inhibition (AMI) in Veterans before and after undergoing total knee arthroplasty surgery. This is an impactful innovation because it addresses an unmet clinical need by leveraging state-of-the-art electrode technology and a custom-developed user interface to establish the first-of-its-kind neuromechanical database in Veterans with knee pain. We expect that this will serve as a novel biomarker of knee health and support future VA research aimed at improving therapeutics for Veterans with knee osteoarthritis. Specific Aims: This device development Merit application has 3 aims. Aim 1 will optimize a fully automated nerve conduction testing tool using custom developed software and high-density stimulating and recording electrode arrays. Aim 2 will establish the first-of-its-kind Neuromechanical Database to Advance Veteran Health. Aim 3 will develop a novel AMI biomarker using machine learning. Methodology: This study uses an iterative design cycle in Aim 1 to optimize a working prototype that leverages our automated software interface and designs, fabricates, and deploys high-density stimulating and recording electrodes. Our Smart Nerve Stimulator will quantify AMI as the ratio H-reflex:M-max that represents the spinal and muscle excitability. Aim 2 uses a cross-sectional study design to evaluate arthrogenic muscle inhibition in 3 Veteran groups: 1) Veterans with knee osteoarthritis who are scheduled to undergo total knee arthroplasty surgery, 2) Veterans who are age/sex-matched but without any knee symptoms or pathology, and 3) Veterans who are 25-45 years of age and sex-matched without any knee symptoms or pathology. Aim 3 uses our innovative biomechanically informed latent neuromechanical dynamics learning architecture to automatically differentiate between Veterans with knee osteoarthritis, total knee arthroplasty, and healthy controls. We will quantify arthrogenic muscle inhibition before and after total knee arthroplasty to evaluate the effects of surgery on neuromechanical function. We will also quantify arthrogenic muscle inhibition with young and age-matched Veterans without knee pain to establish test-retest reliability. Path to Translation/Implementation: Our Smart Nerve Stimulator has strong paths towards translation towards commercialization as well as implementation into knee osteoarthritis research conducted at the CReATE Motion Center at the CMCVAMC and Atlanta VAMC. Our team will work with the University of Pennsylvania and CMCVAMC to protect our intellectual property and evaluate a path towards commercialization.