Spinal reflex conditioning system for enhancing motor function recovery after incomplete spinal cord injury

脊髓反射调理系统增强不完全脊髓损伤后运动功能恢复

• 批准号: 10045442
• 负责人: Isaac Perry Clements
• 金额: $ 85.68万
• 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/10045442
• 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; 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.

项目摘要 脊髓损伤（SCI）在美国影响约30万人，每年有11,000例新病例。 SCI之后，脊柱反射 功能变得异常，导致运动障碍和痉挛，影响65-78％ 与科幻。恢复脊柱反射途径的功能是一个主要的治疗目标。当前疗法 只有中度成功；运动功能通常不会返回受伤前水平。 国家适应性神经技术中心（NCAN）和汤普森博士领导的研究由Wolpaw博士领导 南卡罗来纳州医科大学（MUSC）开发了一种新型的无创疗法 对特定脊柱反射途径的有益变化。患者通过操作条件学习以修改 大脑对路径的控制。这种修改的控制逐渐改变了途径，并触发了有利的途径 其他途径也可塑性。在患有SCI的人中，脊柱反射调节可减少痉挛，消除 lim脚，并提高步行速度。好处持续存在；他们对日常生活中的人们显而易见。 这种强大的新疗法的临床翻译现在是不切实际的，因为反射调节系统是 复杂，需要一个训练有素的操作员。为了实现其治疗潜力，反射调节需要 可以快速掌握并有效使用治疗师的集成硬件/软件系统。生物电路 技术具有必需的硬件； NCAN和MUSC具有基本的软件和临床专业知识。 Biocircuit在将复杂技术转换为交钥匙系统方面具有良好的记录。一起工作， Biocircuit，NCAN和MUSC的建议，以创建适合宽度临床使用的反射调节系统。 第一阶段 - AIM 1将集成硬件以记录来自多个站点的EMG并刺激周围神经 使用软件来控制记录和刺激，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的录音/刺激平台，NCAN 自动化算法和MUSC的临床方法。通过正式的临床可用性测试，我们将优化 该系统并确认其鲁棒性和可用性。 AIM 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系统控制下，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。 II阶段 - AIM 1将验证新系统对患有慢性不完整SCI的人的有效性。我们 期望使用新系统的反射调节将等于或超过旧系统的反射调节。 AIM 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 福利将等于或超过旧系统的收益。这些研究将确定大型后期II的指标 学习。 AIM 3将收集有关SCI使用的FDA 510（k）提交的安全性数据的初始数据。 该项目将产生强大的临床实用反射调节系统，使这种无创 新疗法以补充传统疗法并增强SCI和其他疾病患者的康复。