Spinal Reflex Conditioning System for Enhancing Motor Function Recovery After Incomplete Spinal Cord Injury

项目摘要 脊髓损伤（SCI）影响美国约300，000人，每年有11，000例新发病例。脊髓损伤后，脊髓反射 功能变得异常，导致运动障碍和痉挛，影响65-78%的人 关于SCI因此，恢复脊髓反射通路的功能是主要的治疗目标。当前疗法 只有中等程度的成功;运动功能往往不能恢复到受伤前的水平。 由国家适应性神经技术中心（NCAN）的Wolpaw博士和Thompson博士领导的研究 在南卡罗来纳州医科大学（MUSC）， 有益的变化，具体的脊髓反射途径。病人通过操作性条件反射学会改变 大脑对通路的控制这种修改后的控制逐渐改变途径，并触发有利的 其他途径的可塑性。在SCI患者中，脊髓反射调节可减少痉挛， 跛行，并增加步行速度。这些好处持续存在;它们在人们的日常生活中是显而易见的。 这种强大的新疗法的临床翻译现在是不切实际的，因为反射条件反射系统 复杂，需要训练有素的操作员。为了实现其治疗潜力，反射条件反射需要一个 集成的硬件/软件系统，可以快速掌握和治疗师有效使用。BioCircuit 技术公司拥有必要的硬件; NCAN和MUSC拥有必要的软件和临床专业知识。 BioCircuit在将复杂技术转化为交钥匙系统方面有着良好的记录。一起工作， BioCircuit、NCAN和MUSC提议创建一种适合广泛临床使用的反射调节系统。 第一阶段- Aim 1将整合硬件以记录多个部位的EMG并刺激外周神经 通过软件控制记录和刺激，并向患者提供实时视觉反馈， 结果给治疗师。这个新系统将结合联合收割机BioCircuit的记录/刺激平台，NCAN的 自动算法和MUSC的临床方法。通过正式的临床医生可用性测试，我们将优化 系统，并确认其鲁棒性和可用性。目标2将确定器械的合规性和监管性 基于FDA反馈的途径，将开发置于设计和质量体系控制之下，确保监管 合规性，并指导II期临床研究和未来FDA 510（k）提交的途径。 第二阶段-目标1将验证新系统在慢性不完全SCI患者中的有效性。我们 预期新系统的反射条件作用将等于或超过旧系统。目标2将评估 新系统对运动功能、生活质量和社区参与的影响。我们预计， 福利将等于或超过旧制度的福利。这些研究将确定一个大型的二期后 study.目标3将收集用于SCI的FDA 510（k）提交的安全性初始数据。 该项目将产生一个强大的临床实用反射调节系统，使这种非侵入性的 新的疗法，以补充传统疗法，并促进恢复的人与SCI和其他疾病。

Project Summary Spinal Cord Injury (SCI) affects ~300,000 people in the US, with 11,000 new cases/year. After SCI, spinal reflex function becomes abnormal, contributing to motor impairments and spasticity that affects 65-78% of people with SCI. Thus, restoring the function of spinal reflex pathways is a major therapeutic goal. Current therapies are only moderately successful; motor function often does not return to pre-injury levels. Research led by Dr. Wolpaw at the National Center for Adaptive Neurotechnologies (NCAN) and Dr. Thompson at the Medical University of South Carolina (MUSC) has developed a novel noninvasive therapy that targets beneficial change to specific spinal reflex pathways. The patient learns, through operant conditioning, to modify the brain’s control over the pathway. This modified control gradually changes the pathway, and triggers favorable plasticity in other pathways as well. In people with SCI, spinal reflex conditioning reduces spasticity, eliminates limping, and increases walking speed. The benefits persist; and they are apparent to people in their daily lives. Clinical translation of this powerful new therapy is now impractical because the reflex conditioning system is complex and requires a highly-trained operator. To realize its therapeutic potential, reflex conditioning needs an integrated hardware/software system that can be mastered quickly and used effectively by therapists. BioCircuit Technologies has the essential hardware; NCAN and MUSC have the essential software and clinical expertise. BioCircuit has a strong record in transforming complex technology into turnkey systems. Working together, BioCircuit, NCAN, and MUSC propose to create a reflex conditioning system suitable for widespread clinical use. Phase I - Aim 1 will integrate hardware to record EMG from multiple sites and stimulate the peripheral nerve with software to control recording and stimulation and provide real-time visual feedback to the patient and results to the therapist. This new system will combine BioCircuit’s recording/stimulation platform, NCAN’s automated algorithms, and MUSC’s clinical methods. Through formal clinician usability tests, we will optimize the system and confirm its robustness and usability. Aim 2 will establish the device compliance and regulatory pathway based on FDA feedback, bring development under design and quality system control, ensure regulatory compliance, and guide the Phase II clinical study and the pathway to a future FDA 510(k) submission. Phase II - Aim 1 will validate the effectiveness of the new system in people with chronic incomplete SCI. We expect that reflex conditioning with the new system will equal or exceed that of the old system. Aim 2 will assess the impact of the new system on motor function, quality of life, and community participation. We expect that its benefits will equal or exceed those of the old system. These studies will identify metrics for a large post-Phase II study. Aim 3 will gather initial data on safety for an FDA 510(k) submission for use in SCI. This project will produce a robust clinically practical reflex conditioning system that enables this noninvasive new therapy to complement traditional therapies and enhance recovery for people with SCI and other disorders.