ShEEP Request for Ultra-High-Frequency Ultrasound VisualSonics Imaging System

用于神经系统的电刺激或记录的神经接口已经证明， 具有各种神经或身体残疾的退伍军人康复的巨大潜力， 神经假体、感觉神经假体和用于脑计算机的皮质内微电极 接口（BCI）。我们的研究涉及开发下一代神经调节疗法和神经 修复方法，以改善患有各种神经或身体残疾的人的生活， 脊髓损伤、中风、截肢或瘫痪。该团队的研究跨越了神经接口设备 开发，神经接口的临床前评估，以及临床实施，包括 神经接口的安全性和有效性监测。在团队的所有研究中，有一个关键的需要，要么A） 更好地显示装置-组织界面，或B）在体内定量评估响应的特定组织健康 涉及旨在改善装置-组织界面的治疗。在这两种情况下，都需要非常高的 分辨率实时成像技术是非侵入性的，因此可以在多个时间点应用， 在整个研究过程中。 所要求的Vevo 3100 LT是FUJIFILM VisualSonics产品组合的一部分， 世界上第一个单触式超声平台，帮助用户以最高分辨率可视化数据 (down至30 µm，或比标准临床超声好10倍）。该系统结合了许多特征， 如高清图像处理，以减少斑点噪声和伪影，使其成为小动物的理想系统 和浅表临床成像（经批准的IRB方案）。广泛的探头范围（9-70 MHz）为用户提供 能够为每个独特的动物模型和应用选择理想的成像频率和深度。 首席PI，Shoffstall博士最近完成了他的CDA-1，并在克利夫兰建立了一个新的实验室 VAMC获得新的Merit Review资助（预计于2020年7月开始）。他有多个正在进行和未来的项目 这套设备对他们来说很有价值此外，他还召集了一批调查人员 包括具有多个优点审查的人员以及初级调查人员，所有这些人员都需要 高频超声技术，以有利于他们正在进行的研究目标。对于目前的拨款申请， 调查人员已确定了这一设备将有助于的几个至关重要的领域， 具体围绕神经接口或相关治疗的评估，包括： 实验疗法的体内监测 手术计划和神经界面植入物监测 术中神经束解剖研究 超声波作为治疗干预/神经调节 潜在获益（次要潜在获益）; VA医生在临床病例中的使用（经IRB批准的方案） 调查人员之间有着很强的合作历史， 展示资源共享和设备维护的先例。由于设备 价格约为15万美元，在一次Merit Review中证明其费用是合理的，这将是一个挑战。羊 是团队获得核心设备的理想机制，可以支付大量的前期成本。个人 额外的传感器成本约为2万美元，并且可以编入未来的赠款预算，以满足特定的研究需求。的 设备将被安置在APT中心实验室内，可以很容易地在实验室之间移动，包括 动物设施。如果得到资助，这一设备将大大扩展我们调查人员的成像能力， 提高多个VA资助的研究项目的质量。

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 µm, 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.