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

项目摘要 在美国，脊髓损伤(SCI)影响着大约30万人，每年新增11000例。脊髓损伤后，脊髓反射 功能异常，导致运动障碍和痉挛，影响65%-78%的人 和SCI一起。因此，恢复脊髓反射通路的功能是治疗的主要目标。当前的治疗方法 运动功能通常不会恢复到受伤前的水平。 国家自适应神经技术中心(NCAN)的沃尔帕博士和汤普森博士领导的研究 在南卡罗来纳医科大学(MUSC)，他开发了一种新的非侵入性疗法，目标是 对特定的脊髓反射路径进行有益的改变。患者通过操作性条件反射学习修改 大脑对这条通路的控制。这种改进的控制逐渐改变了途径，并触发了有利的 其他途径的可塑性也是如此。在脊髓损伤患者中，脊髓反射训练减少痉挛，消除 一瘸一拐的，并提高了行走速度。这些好处持续存在；人们在日常生活中也明显看到了这些好处。 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，可以快速掌握并有效地被治疗师使用。生物回路 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。 生物电路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， 生物回路、NCAN和MUSC建议创造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，记录多个部位的肌电并刺激周围神经 使用软件控制记录和刺激，并向患者提供实时视觉反馈 结果传给治疗师。这一新系统将结合生物电路的记录/刺激平台NCAN 自动化算法和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 并验证了该系统的健壮性和可用性。目标2将建立设备合规性和监管 根据FDA的反馈，将开发置于设计和质量体系控制之下，确保监管 依从性，并指导第二阶段临床研究和未来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性脊髓损伤患者中的有效性。我们 预计新系统的条件反射将与旧系统持平或超过旧系统。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。我们期望它的 福利将与旧制度持平或超过旧制度。这些研究将确定大型第二阶段后的指标 学习。AIM 3将为FDA 510(K)提交的用于SCI的安全性收集初步数据。 该项目将产生一种强大的临床实用反射调节系统，使这种非侵入性 补充传统疗法的新疗法，促进脊髓损伤和其他疾病患者的康复。

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.