Peripheral Interfaces in Amputees for Sensorimotor Integration

在国家服役中失去上肢的退伍军人失去了手的功能和感觉 触摸。失去这些与世界的身体、操纵和情感联系的主要来源 导致终身的功能和社会缺陷。为了恢复手部的情感和功能， 作为一名老兵，我们开发了一种神经电极植入系统， 和肌内电极，以提供直观、长期、稳定的假体控制， 人手的功能。我们已经在四个受试者中成功部署了这些电极接口， 6年以上无重大不良事件。实验室中的几项病例系列研究表明， 感觉恢复和假肢控制的重要方面。一个为期五周的家庭病例系列表明， 即使是一个自由度的假体也具有恢复感觉的显著优点。超出 与传统假肢不同，新系统已连接到一只先进的、类似人手的手，该手具有 在九个位置处的传感器将与对用户的感觉反馈一起使用，并且具有 食指、拇指、手腕、中指至无名指作为一组。 最初的试验通过皮肤实现了电线连接到接口，但现在我们有了 完成了完全植入的蓝牙LE ™连接系统的开发，以消除这些连接。 下一步需要将这项新技术推向退伍军人的治疗， 一项随机临床试验（RCT），比较了植入神经和肌肉界面的先进假体治疗 到传统的、最先进的、临床上规定的假体治疗。具有感觉反馈的植入系统 和高自由度的控制，预计将改善受试者的结果比目前可用 选项.这项试点试验的结果将确定先进假体的可行性和重要性， 将支持后续的关键试验 这项研究有两个目的。目标1将决定功能成果、社会成果和 与受试者的临床处方、状态 艺术假肢治疗。8名受试者将参加一项随机、2 x 2交叉研究， 新的仿人手假肢与受试者的商业假肢植入接口。我们 主要假设是，在骨科和假体用户调查的受试者差异中- 使用高级假体系统后，寿命（OPUS-QOL）指标将显示显著改善。我们将 收集每周一次的心理社会结局调查，并记录受试者在家时的器械使用情况。科目 将每月来实验室进行功能测试和更大范围的调查，以了解 假体对患者日常生活的影响。目标2将确定是否恢复感觉反馈 单独或单独使用多个自由度可改善功能结局、社会结局和 假肢目标1交叉研究后，受试者将继续进行第二项2 x 2交叉研究 将具有受试者的商业假体的功能的感觉反馈与没有感觉的感觉反馈进行比较， 全功能先进假肢我们的主要假设是，在主题差异的措施， 将表明感觉反馈和植入控制均显著改善OPUS-QOL测量 与受试者的临床处方假体治疗相比，但不如两者一起强烈。我们 还将收集和分析与目标1相同的广泛数据集。 这项拟议中的研究将是第一个部署一个完全植入接口的假体治疗， 长期、家用、随机临床试验。预计这将是一个重大的飞跃， 先进的感官功能，直观，高自由度的假肢系统，可用于改善生活质量， 为失去上肢的退伍军人提供的选择。

Veterans who have lost an upper extremity in service of country have lost both hand function and the sense of touch. Losing these primary sources of physical, manipulative, and emotional connection to the world results in lifelong functional and social deficits. To restore the emotional and functional aspects of the hand to a veteran, we have developed an implanted system of nerve electrodes to restore touch and sense of movement and intramuscular electrodes to provide intuitive, long-term, stable control of prostheses with the look and functions of a human hand. We have successfully deployed these electrode interfaces in four subjects for more than six years without significant adverse events. Several case-series studies in-lab demonstrate multiple important aspects of sensory restoration and prosthesis control. A five-week, in-home case series demonstrated significant advantages to restoring sensation with even a one degree-of-freedom prosthesis. Beyond the traditional prostheses, the new system has been connected to an advanced, human hand-like hand that has sensors at nine locations to be used with the sensory feedback to the user and has individual motion of the index finger, thumb, wrist, and middle through ring finger as a single group. The initial trials implemented wires through the skin as connection to the interfaces, but now we have completed development of a fully-implanted, BluetoothLE™connected system to eliminate these connections. The next step required to move this new technology towards making the treatment available to veterans is a larger, pilot randomized clinical trial (RCT) comparing an advanced prosthesis treatment with implanted nerve and muscles interfaces to traditional, state-of-art, clinically-prescribed prosthesis treatment. The implanted system with sensory feedback and high degree-of-freedom control is expected to improve the subjects’ outcomes over currently-available options. The results of this pilot trial will establish the viability and importance of the advanced prostheses and will support a subsequent pivotal trial. The study has two aims. Aim 1 will determine the functional outcomes, social outcomes, and usage of an advanced prostheses with implanted electrodes compared to the subject’s clinically prescribed, state-of- art prosthesis treatment. Eight subjects will participate in a randomized, 2 x 2 cross-over study comparing the new human hand-like prosthesis with implanted interfaces to the subject’s commercial prosthesis. Our primary hypothesis is that within subject differences of the Othortics and Prosthetics User Survey - Quality of Life (OPUS-QOL) measure will show significant improvement with the advanced prosthesis system. We will collect weekly surveys for psychosocial outcomes and log device usage when subjects are at home. Subjects will come to the lab monthly for functional tests and a larger range of surveys to understand the explore the impact of the prosthesis on the subject’s daily life. Aim 2 will determine if restoration of sensory feedback alone or multiple degrees-of-freedom alone improves functional outcomes, social outcomes, and usage of the prosthesis. Following the Aim 1 cross-over study, subjects will continue in a second 2 x 2 cross-over study comparing sensory feedback with the function of the subject’s commercial prosthesis to no sensory with the fully functional advanced prosthesis. Our primary hypothesis is that within subject differences of the measures will show that both sensory feedback and implanted control significantly improve the OPUS-QOL measure compared to the subject’s clinically prescribed prosthesis treatment, but not as strongly as both together. We will also collect and analyze the same extensive data set as in Aim 1. The proposed research will be the first to deploy a prosthetic treatment with a fully-implanted interface in a long-term, home-use, randomized clinical trial. This is expected to make a significant leap forward toward making advanced sensory-enabled, intuitive, high degree-of-freedom prosthetic systems available to improve quality of life and options for veterans with upper limb loss.