Development of the CopyCat FES System to Improve Hand Recovery After Stroke

描述(申请人提供)：上肢偏瘫是中风引起的最严重和最常见的损伤之一。在美国每年发生的近80万中风中，约有75%会导致不同程度的上肢瘫痪。大约三分之一的中风幸存者患有慢性偏瘫，日常生活活动严重依赖照顾者。对侧控制功能电刺激(CCFES)是一种新的治疗方法，旨在通过积极的意图驱动运动和重复的刺激运动相结合来促进手运动的恢复。CCFES刺激偏瘫患者的手张开，刺激强度由戴在未受影响的手上的仪表盘手套调节。因此，非患手的意志性张开会使患手产生成比例的张开量(偏瘫的手“复制”非轻瘫的手)，允许患者进行积极的、重复的张手练习和功能性任务。CCFES通过采用康复技术来满足中风患者的独特需求，这些技术被证明可以促进神经恢复，提高大脑在受伤后进行重组的能力，恢复受影响肢体的运动控制。CCFES治疗已经在两个试点病例研究和早期随机对照试验(RCT)中得到证明，以减少手损伤和改善手功能。正在进行的研究包括一项关于慢性偏瘫疗效的大型RO1随机对照试验，一项研究手部增加刺激伸肘的效果的初步研究，一项改善脚踝背屈的R21随机对照试验，以及最近资助的一项研究手部增加刺激伸肘的RO1随机对照试验。CCFES治疗是一种经过科学验证的治疗方法，预计将具有巨大的商业潜力。然而，为了成功地将基于实验室的设备从单站点研究转移到多站点研究和商业化，研究级设备需要重新设计，以提高可制造性、耐用性、易用性和编程，使其适合广泛传播。StimDesign LLC将与凯斯西储大学CCFES治疗的发明者、克利夫兰FES中心和Win Enterprise合作，在这个第一阶段SBIR项目中开发和测试第一个商业手写仿制FES系统。具体目标是：1)设计和生产符合设计和功能规格的试生产仿制FES系统，以及2)对新的仿制FES系统进行功能、安全性和临床可用性测试。该项目是推进CCFES治疗和准备第一个多点试验的关键一步。商业化不仅将在绝望的人群中促进中风后的手部康复，寻找更好的解决方案，还将推动FES康复研究领域的发展。

DESCRIPTION (provided by applicant): Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the nearly 800,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately one-third of stroke survivors develop chronic hemiparesis with significant dependence on caregivers for activities of daily living. Contralaterally controlled functional electrical stimulation (CCFES) is a new treatment designed to improve hand motor recovery through active intention-driven movement combined with repetitive stimulated movement. CCFES stimulates paretic hand opening with a stimulation intensity that is regulated by an instrumented glove worn on the unaffected hand. Therefore, volitional opening of the unaffected hand produces a proportional amount of opening of the affected hand (the paretic hand "copies" the non-paretic hand), allowing the patient to practice active, repetitive hand opening exercises and functional tasks. CCFES meets the unique demands of stroke patients by incorporating rehabilitation techniques shown to promote neural recovery and boost the brain's capacity to reorganize after injury, restoring motor control of affected limbs. CCFES treatment has been shown in two pilot case studies and in an early-phase randomized controlled trial (RCT) to reduce hand impairment and improve hand function. Ongoing studies include a large RO1 RCT of the efficacy in chronic hemiplegia, a pilot study investigating the effect of adding stimulated elbow extension to hand, an R21 RCT to improve ankle dorsiflexion, and a recently funded RO1 RCT to investigate the addition of stimulated elbow extension to hand. CCFES treatment is a scientifically proven therapy and is expected to have significant commercial potential. However, to achieve successful technology transfer of the lab-based device from single-site research studies to multi-site studies and commercialization, the research-grade device needs to be redesigned for improved manufacturability, durability, and ease-of-use and programming to make it suitable for widespread dissemination. StimDesigns LLC, in collaboration with the inventors of CCFES treatment from Case Western Reserve University, Cleveland FES Center and WIN Enterprises will develop and test the first commercial Hand CopyCat FES system in this Phase I SBIR project. The specific aims are: 1) Design and produce pre- production CopyCat FES systems that meet the design and functional specifications, and 2) Conduct functional, safety and clinical usability testing of the new CopyCat FES systems. This project is a critical step in advancing CCFES therapy and preparing for the first multi-site trail. Commercialization will not only enhance hand recovery after stroke n a desperate population looking for better solutions but also, advance the field of FES rehabilitation research.