Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals with Acute Spinal Cord Injury

急性脊髓损伤患者运动和膀胱功能的系统间闭环控制

• 批准号: 10259668
• 负责人: Claudia Angeli
• 金额: $ 163.92万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10259668
• 关键词: Activities of Daily Living; Acute; Address; Autonomic Dysreflexia; Autonomic nervous system; Awareness; Bladder; Blood Pressure; Blood Pressure Monitors; Cardiovascular system; Catheterization; Chronic; Chronic Phase; Clinical Trials; Communication; Communities; Data; Development; Devices; Diastolic blood pressure; Educational Intervention; Evaluation; Feedback; Heart Rate; Home; Impairment; Implant; Incidence; Individual; Injury; Intestines; Laboratories; Locomotion; Locomotor training; Manuals; Measures; Monitor; Motor; Movement; Participant; Patients; Persons; Phase; Physiological; Positioning Attribute; Publishing; Quality of life; Rain; Randomized; Recovery; Regulation; Reporting; Series; Spinal Cord; Spinal cord injury; Symptoms; System; Systolic Pressure; Technology; Testing; Time; Training; Training Programs; United States; Walking; base; blood pressure regulation; design; experience; flexibility; implementation facilitation; improved; intimate behavior; learning algorithm; locomotor control; locomotor tasks; motor function recovery; neural circuit; neuroregulation; normotensive; prediction algorithm; prevent; sensor; sensory system; therapeutic evaluation; tool; treadmill; treatment effect; wireless communication; wireless sensor

SUMMARY ABSTRACT More than 1.2 million people in the United States have a spinal cord injury (SCI), and each year there are 10,000 new cases. In the last few years, we have shown that neuromodulation using epidural stimulation of the lumbosacral spinal cord can activate latent neural circuits and restore voluntary movement, standing and stepping in individuals with chronic SCI. One participant in this study also reported gains in bladder function following training with spinal cord epidural stimulation. However, there are persistent gaps that need to be filled in order to advance the field of neuromodulation forward. Technological advances to upgrade the stimulator’s programming and wireless communication platforms are critically needed in order to integrate multiple training paradigms across multiple systems (i.e. motor and autonomic), as well as take advantage of wireless monitoring technology that could improve the patient experience. For this study, first we will acquire data necessary for the implementation of learning algorithms and closed-loop systems with the implanted neurostimulator. Second, 8 additional individuals will be randomized into training interventions for locomotion and bladder. The purpose of this phase is to implement the closed-loop controls and learning algorithms developed with data from phase 1. This two phase design will allow us to acquire necessary data for the development of technical tools with a group of 8 individuals, and test the closed-loop controls with a second group of individuals that have not received prior to training. This trial will upgrade technology for epidural stimulation and make it specific for use by individuals with spinal cord injury.

摘要 美国有超过120万人患有脊髓损伤（SCI），每年有1万人 新案子在过去的几年里，我们已经证明，使用硬膜外刺激的神经调节， 腰骶脊髓可以激活潜在的神经回路，恢复自主运动，站立和 介入慢性脊髓损伤患者这项研究的一名参与者还报告了膀胱功能的改善 在脊髓硬膜外刺激训练后。然而，仍然存在需要填补的空白 以推动神经调节领域的发展。技术进步升级刺激器的 为了整合多种训练，迫切需要编程和无线通信平台 跨多个系统的范例（即运动和自主），以及利用无线监控 可以改善患者体验的技术。在这项研究中，首先我们将获得必要的数据， 使用植入式神经刺激器实现学习算法和闭环系统。第二，8 另外的个体将被随机分配到运动和膀胱的训练干预中。的目的 该阶段是实施闭环控制和利用来自阶段1的数据开发的学习算法。 这两个阶段的设计将使我们能够获得必要的数据，与一个小组开发技术工具， 的8个人，并测试与第二组的人，没有收到事先闭环控制 训练。这项试验将升级硬膜外刺激技术，并使其具体用于个人 脊髓损伤