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

用于增强脊髓不完全损伤后运动功能恢复的脊髓反射调节系统

• 批准号: 10267681
• 负责人: Isaac Perry Clements
• 金额: $ 85.03万
• 依托单位: BIOCIRCUIT TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10267681
• 关键词: Activities of Daily Living; Adoption; Adverse event; Affect; Aftercare; Algorithmic Software; Baclofen; Categories; Chronic; Classification; Clinical; Clinical Research; Community Participation; Complement; Complex; Computer software; Data; Development; Devices; Disease; Ensure; Evaluation; Feedback; Future; Goals; H-Reflex; Impairment; Injury; Learning; Location; Locomotor training; Measures; Medical; Medical Device; Methods; Motor; Muscle; Nerve; Neuromuscular Diseases; Operant Conditioning; Outcome; Pathway interactions; Patients; Peripheral Nerves; Persons; Pharmacology; Phase; Population; Posterior Tibial Nerves; Protocols documentation; Quality of life; Recovery; Recovery of Function; Reflex action; Regulatory Pathway; Reporting; Research; Research Personnel; Risk Assessment; Safety; Signal Transduction; Site; Soleus Muscle; South Carolina; Spinal cord injury; Stroke; Structure; System; Systems Integration; Technology; Testing; Therapeutic; Time; Training; Treatment Protocols; Universities; Walking; abnormal reflex; animal data; automated algorithm; base; clinical translation; conditioning; design; effectiveness validation; efficacy trial; functional restoration; human data; mind control; motor function improvement; motor function recovery; motor impairment; movement practice; neural stimulation; neuromuscular stimulation; neurotechnology; novel; novel therapeutics; phase 2 study; software systems; spasticity; spinal reflex; targeted treatment; traditional therapy; usability; visual feedback; walking speed

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.

项目概要 脊髓损伤 (SCI) 影响美国约 300,000 人，每年新发病例 11,000 例。 SCI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 与SCI。因此，恢复脊髓反射通路的功能是主要的治疗目标。目前的疗法 仅取得了一定的成功；运动功能通常不会恢复到受伤前的水平。 由国家自适应神经技术中心 (NCAN) 的 Wolpaw 博士和 Thompson 博士领导的研究 南卡罗来纳医科大学 (MUSC) 开发了一种新型非侵入性疗法，针对 对特定脊髓反射途径的有益改变。患者通过操作性条件反射学习改变 大脑对通路的控制。这种修改后的控制逐渐改变路径，并触发有利的 其他途径也具有可塑性。对于 SCI 患者，脊髓反射调节可以减少痉挛，消除 跛行，并提高行走速度。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转化现在是不切实际的，因为反射调节系统是 复杂，需要训练有素的操作员。为了发挥其治疗潜力，反射调节需要 集成的硬件/软件系统，治疗师可以快速掌握并有效使用。生物电路 技术拥有必要的硬件； 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拥有良好的记录。共同努力， 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 - 目标 1 将集成硬件以记录多个部位的肌电图并刺激周围神经 使用软件控制记录和刺激并向患者提供实时视觉反馈 结果给治疗师。这个新系统将结合 BioCircuit 的记录/刺激平台、NCAN 的 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 系统并确认其稳健性和可用性。目标 2 将建立设备合规性和监管 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 将验证新系统对慢性不完全 SCI 患者的有效性。我们 预计新系统的反射调节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。我们期望其 效益将等于或超过旧系统的效益。这些研究将确定第二阶段后大型项目的指标 学习。目标 3 将为用于 SCI 的 FDA 510(k) 提交收集安全性的初步数据。 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 新疗法可补充传统疗法并促进 SCI 和其他疾病患者的康复。