OBJECTIVE:To investigate the feasibility of implanting microstimulators to deliver programmed nerve stimulation for sequenced muscle activation to recover arm-hand functions. DESIGN:By using a minimally invasive procedure and local anesthesia, 5 to 7 microstimulators can be safely and comfortably implanted adjacent to targeted radial nerve branches in the arm and forearm of 7 subjects with poststroke paresis. The microstimulators' position should remain stable with no tissue infection and can be programmed to produce effective personalized functional muscle activity with no discomfort for a preliminary 12-week study. Clinical testing, before and after the study, is reported in the accompanying study. SETTING:Microstimulator implantations in a sterile operating room. PARTICIPANTS:Seven adults, with poststroke hemiparesis of 12 months or more. INTERVENTION:Under local anesthesia, a stimulating probe was inserted to identify radial nerve branches. Microstimulators were inserted by using an introducer and were retrievable for 6 days by attached suture. Each device was powered via a radiofrequency link from 2 external cuff coils connected to a control unit. MAIN OUTCOME MEASURES:To achieve low threshold values at the target sites with minimal implant discomfort. Microstimulators and external equipment were monitored over 12 weeks of exercise. RESULTS:Seven subjects were implanted with 41 microstimulators, 5 to 7 per subject, taking 3.5 to 6 hours. Implantation pain levels were 20% more than anticipated. No infections or microstimulator failures occurred. Mean nerve thresholds ranged between 4.0 to 7.7 microcoulomb/cm(2)/phase over 90 days, indicating that cathodes were within 2 to 4 mm of target sites. In 1 subject, 2 additional microstimulators were inserted. CONCLUSIONS:Microstimulators were safely implanted with no infection or failure. The system was reliable and programmed effectively to perform exercises at home for functional restoration.

译文

目的:探讨植入微刺激器以提供程序性神经刺激以进行顺序肌肉激活以恢复手臂功能的可行性。
设计:通过微创手术和局部麻醉,可以安全舒适地将5至7种微刺激器植入7名卒中后轻瘫患者的手臂和前臂的radial骨目标神经分支附近。微刺激器的位置应保持稳定,没有组织感染,并且可以进行编程,以产生有效的个性化功能性肌肉活动,而不会进行为期12周的初步研究。在研究之前和之后的临床测试报告在随附的研究中。
地点:在无菌手术室中植入微刺激器。
参与者:七名成年人,卒中后偏瘫为12个月或更长时间。
干预:在局部麻醉下,插入刺激探针以识别radial神经分支。通过使用导引器插入微刺激器,并通过缝合线将其恢复6天。每个设备都通过射频链路由连接到控制单元的2个外部袖带线圈供电。
主要观察指标:在目标部位达到低阈值,并使植入物不适感降至最低。在运动的12周内对微刺激器和外部设备进行了监测。
结果:七名受试者植入了41种微刺激器,每名受试者5至7个,时间为3.5至6个小时。植入疼痛水平比预期高20%。没有发生感染或微刺激器故障。在90天内,平均神经阈值范围在4.0至7.7微库仑/ cm(2)/阶段之间,表明阴极位于目标部位的2至4 mm之内。在1名受试者中,插入了2个额外的微刺激器。
结论:微刺激器被安全植入,没有感染或失败。该系统可靠且编程有效,可以在家中进行锻炼以恢复功能。

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