Implanted Neuroprosthesis for Restoring Arm and Hand Function after Stroke

描述（由申请人提供）：中风是美国老年人严重、长期残疾的主要原因。近三分之一的中风幸存者患有慢性偏瘫。中风最常见的持续性后果之一是手部功能受损。该研究项目的长期目标是开发一种植入式神经肌肉电刺激（NMES）神经假体，使中风幸存者能够再次使用他们麻痹的手臂和手进行日常生活活动。这项探索性研究建议在两名慢性中风幸存者（中风后6个月）中实施神经假体，该神经假体先前已成功地应用于四肢瘫痪脊髓损伤患者。具体目的是建立在中风幸存者中实施该系统的可行性，并评估神经假体对上肢运动障碍和活动限制的影响。参与者将接受植入神经假体的外科手术。植入的组件包括多通道刺激遥测器、刺激电极和肌电记录电极。刺激电极将被植入瘫痪的上肢肌肉。肌电记录电极将被植入受试者保持自主控制的上肢肌肉。个体将通过特定的肌肉收缩来控制他们受到刺激的手臂和手的运动。特别注意将致力于创造控制策略，是直观的对象，不需要不自然的运动或肌肉收缩。术后过程包括3-4周的固定，然后是4-6周的肌肉刺激强化，然后是两周的系统定制和训练。系统实施的可行性和有效性将通过技术性能、安全性和临床结果的评估进行评估，评估将在培训期后的3、6和9个月进行。临床评估将包括使用和不使用神经假体时上肢运动损伤和活动限制的测量，并将其与基线评估进行比较。神经假体有望使使用者能够执行无法独立完成的手工任务。本研究的成功完成将：a)证明植入式上肢神经假体用于偏瘫中风幸存者的可行性，b)为改进该技术提供有价值的信息，从而可以定义和扩展其在中风中的适用性，c)提供神经假体对运动损伤和活动限制的影响的初步估计，d)生成用于设计R01疗效试验的试点数据。

DESCRIPTION (provided by applicant): Stroke is the leading cause of severe, long-term disability among older adults in the United States. Nearly one third of stroke survivors have chronic hemiparesis. One of the most frequently persisting consequences of stroke is impaired hand function. The long-term objective of this research program is to develop an implanted neuromuscular electrical stimulation (NMES) neuroprosthesis that enables stroke survivors to use their paretic arm and hand again to perform activities of daily living. This exploratory study proposes to implement in two chronic stroke survivors (> 6 months post-stroke) a neuroprosthesis that has previously been successfully implemented in tetraplegic spinal cord injury patients. The specific aims are to establish the feasibility of implementing the system in stroke survivors and to evaluate the effect of the neuroprosthesis on upper extremity motor impairment and activity limitation. The participants will undergo a surgical procedure in which the neuroprosthesis will be implanted. The implanted components include a multi- channel stimulator-telemeter, stimulation electrodes, and EMG-recording electrodes. The stimulating electrodes will be implanted on paralyzed upper extremity muscles. The EMG-recording electrodes will be implanted on upper extremity muscles of which the subject retains voluntary control. The individual will control their stimulated arm and hand movements by making particular muscle contractions. Special attention will be devoted to creating control strategies that are intuitive to the subjects and do not require unnatural movements or muscle contractions. The post-surgical course includes 3-4 weeks of immobilization, then 4-6 weeks of muscle strengthening with stimulation, followed by a two-week period of system customization and training. Feasibility of system implementation and effectiveness will be evaluated with assessments of technical performance and safety and clinical outcomes, which will be made at 3, 6, and 9 months after the training period. The clinical assessments will include measurements of upper extremity motor impairment and activity limitation with and without using the neuroprosthesis, which will be compared to baseline assessments. The neuroprosthesis is expected to enable the users to perform bimanual tasks that cannot be independently achieved otherwise. The successful completion of this study will: a) demonstrate the feasibility of an implanted upper extremity neuroprosthesis for hemiplegic stroke survivors, b) provide valuable information for improving the technology so that its applicability in stroke may be defined and expanded, c) provide an initial estimate of the effect of the neuroprosthesis on motor impairment and activity limitation, and d) generate pilot data to be used to design an R01 efficacy trial.