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

用于电刺激或记录神经系统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，从运动 用于脑计算机的神经假体、感觉神经假体和皮质内微电极 接口(BCI)。我们的研究涉及开发下一代神经调节疗法和神经 改善各种神经或身体残疾患者生活的假体方法，包括 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 神经接口的开发、临床前评估，以及一直到临床实施，涉及 神经接口的安全性和有效性监测。在团队的所有研究中，都迫切需要 更好地可视化设备-组织界面，或B)在体内定量评估特定组织的健康状况 到旨在改善设备-组织界面的疗法。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， 纵观整个研究。 所要求的Vevo 3100 LT是Fujifilm Visualsonics产品组合的一部分，该产品组合包括 世界上第一个帮助用户以最高分辨率可视化数据的一触式超声平台 (降至30微米，比标准临床超声好10倍)。该系统结合了多个特征， 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 和肤浅的临床影像(使用经批准的IRB方案)。广泛的探头(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肖夫斯托尔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获得新的功绩审查资金(预计将于2020年7月开始)。他有多个正在进行的和未来的项目 这种设备对它来说将是非常宝贵的。此外，他还召集了一批调查人员 包括那些有多个功绩审查的人以及初级调查人员，他们都有 高频超声技术有利于他们正在进行的研究目标。就目前的拨款申请而言， 调查人员已经确定了几个关键的重要领域，这些领域将得到这种设备的帮助， 特别是围绕神经接口或相关治疗的评估，包括： 对实验性治疗的活体监测 手术计划与神经接口植入物监测 术中神经束解剖研究 超声作为治疗干预/神经调节 (次要潜在益处)；退伍军人管理局医生在临床病例中的使用(具有批准的IRB方案) 调查人员之间有着很强的合作历史，共同拥有许多 展示资源共享和设备维护的先例。作为设备 它的价格约为15万美元，它将是一个挑战，以证明其费用在一次功绩审查。绵羊 是团队获得核心设备的理想机制，支付了大量的前期成本。个体 额外的传感器成本约为20000美元，可以在未来的拨款中编入预算，以满足特定的研究需求。这个 设备将放置在APT中心实验室内，并可以在实验室之间轻松滚动，包括 动物设施。如果获得资金，这台设备将极大地扩展我们调查人员的成像能力 提高退伍军人管理局资助的多个研究项目的质量。

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.