Neural interfaces used for electrical stimulation or recording of the nervous system have demonstrated and vast potential for rehabilitation of Veterans with various neurological or physical disabilities, ranging from motor neural prostheses, sensory neural prosthesis, and intracortical microelectrodes used for Brain-Computer Interfacing (BCI). Our research involves developing the next generation of neuromodulation therapies and neural prosthetic approaches to improve the lives of people with various neurological or physical disabilities, including spinal cord injury, stroke, amputation, or paralysis. The team?s research spans neural interface device development, preclinical evaluation of neural interfaces, and all the way to clinical implementation, involving safety and efficacy monitoring of neural interfaces. In all the team?s studies, there is a critical need to either A) better visualize the device-tissue interface, or B) quantitatively assess, in vivo, specific tissue health in response to therapies aimed at improving the device-tissue interface. In both cases, there is a need for a very high resolution live-imaging technique that is non-invasive so that it can be applied at multiple time points, longitudinally throughout a study. The requested Vevo 3100 LT is part of the FUJIFILM VisualSonics product portfolio which consists of the world?s first one-touch ultrasound platform that helps users visualize data at the highest resolution available (down to 30 m, or 10x better than standard clinical ultrasounds). The system combines a number of features, such as HD image processing, to reduce speckle noise and artifacts, making it the ideal system for small animal and superficial clinical imaging (with approved IRB protocol). The wide range of probes (9-70 MHz) offers users the ability to select the ideal frequency and depth of imaging for each unique animal model and application. The lead PI, Dr. Shoffstall recently completed his CDA-1 and has established a new lab at the Cleveland VAMC with new Merit Review funding (anticipated start July 2020). He has multiple ongoing and future projects for which this equipment would be very valuable. Furthermore, he has assembled an array of investigators spanning those with multiple Merit Reviews as well as Junior level investigators, all whom have needs for the high frequency ultrasound technology to benefit their ongoing research goals. For the present grant application, the investigators have identified several areas of critical importance that would be aided by this equipment, specifically surrounding the evaluation of neural interfaces or associated treatments, including: ? In vivo monitoring of experimental therapies ? Surgical planning and neural interface implant monitoring ? Intraoperative neural-fascicular anatomy studies ? Ultrasound as therapeutic intervention / neuromodulation ? (Secondary potential benefit); VA physician use in clinical cases (with approved IRB protocol) The investigators have a strong history of collaboration with one another, and collectively have many precedent examples that demonstrate resource sharing and maintenance of equipment. As the equipment carries a price of ~$150k, it would be challenging to justify its expense within a single Merit Review. The ShEEP is an ideal mechanism for the team to acquire the core equipment, defraying large upfront costs. Individual additional transducers cost ~$20k, and can be budgeted into future grants to meet specific study needs. The equipment will be housed within the APT Center laboratories and can be easily rolled between labs, including the animal facility. If funded, this equipment would greatly extend our Investigators? imaging capabilities and improve the quality of multiple VA funded research programs.

Public Health Relevance

Implanted medical devices in the central and peripheral nervous system are used for a number of current and future applications including control of tremor (Parkinson?s disease, ~60,000 Veterans?), pain block/relief (chronic pain, >30 million US?), shunting cerebrospinal fluid (hydrocephalous, ~24,000 Veterans?), and brain-controlled prostheses (spinal cord injury paralysis, ~50,000 Veterans?), among others (?: prevalence). The requested equipment in this application is a specialized high frequency ultrasound machine, that will enable enhanced study, surgical planning, and evaluation of implanted neural interfaces, spanning nearly a dozen funded projects within the Cleveland VA Medical Center, and specifically with in the APT and FES Centers of Excellence. There is a strong history of resource sharing and collaboration between the investigators. The equipment is very simple to operate and has very minimal maintenance requirements. It is cart-portable, and will be very easy to share and implement across the investigators? various research projects on this application.

National Institute of Health (NIH)
Veterans Affairs (VA)
Veterans Administration (IS1)
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Special Emphasis Panel (ZRD1)
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Louis Stokes Cleveland VA Medical Center
United States
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