Peripheral Interfaces in Amputees for Sensorimotor Integration

为国家服务而失去上肢的退伍军人失去了手功能和感觉 触觉的力量。失去这些与世界的身体、操控和情感联系的主要来源 导致终生的功能和社会缺陷。将手的情感和功能恢复到 作为一名老兵，我们已经开发出一种植入的神经电极系统，以恢复触摸和运动感 和肌肉内电极，提供直观、长期、稳定的假体控制，外观和 人类手的功能。我们已经成功地在四个受试者中部署了这些电极接口 超过六年没有发生重大不良事件。实验室内的几个案例系列研究证明了 感觉恢复和假体控制的重要方面。为期五周的居家案例系列展示了 即使只有一个自由度的假体也能恢复感觉。超越了 传统的假肢，新的系统已经连接到一个先进的，人类的手一样的手，它有 九个位置的传感器用于向用户提供感官反馈，并具有 食指、拇指、手腕、中指至无名指为一组。 最初的试验实现了通过皮肤连接到接口，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。 推动这项新技术向退伍军人提供治疗所需的下一步是更大规模的试点 比较植入神经和肌肉界面的先进假体治疗的随机临床试验(RCT) 到传统的、最先进的、临床处方的假体治疗。具有感觉反馈的植入式系统 高自由度控制有望改善受试者的结果，而不是目前可用的 选择。这项试点试验的结果将确定先进假体的可行性和重要性，并 将支持随后的关键试验。 这项研究有两个目的。目标1将确定功能结果、社会结果和使用 植入电极的先进假体与受试者的临床处方、状态- 艺术假体治疗。8名受试者将参加一项随机的2x2交叉研究，比较 这种新型的手形假体与受试者的商业假体有植入的接口。我们的 基本假设是，在骨科和假体使用者调查的受试者差异内-质量 随着先进的假体系统的出现，生活质量(OPUS-QOL)将会有显著的改善。我们会 每周收集心理社会结果调查，并在受试者在家时记录设备使用情况。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 假体对受试者日常生活的影响。目标2将确定是否恢复感觉反馈 单独或多个自由度单独改善功能结果、社会结果和使用 假肢。在目标1交叉研究之后，受试者将继续进行第二次2×2交叉研究 将感觉反馈与受试者的商业假体的功能与无感觉与 功能齐全的先进假体。我们的主要假设是，在测量的主体差异内 将显示感觉反馈和植入控制都显著改善了OPUS-QOL测量 与受试者的临床处方假体治疗相比，但不像两者加在一起那么强烈。我们 还将收集和分析与目标1相同的广泛数据集。 这项拟议的研究将是第一个将完全植入界面的假体治疗部署在 长期、家庭使用、随机的临床试验。预计这将实现重大飞跃，实现 先进的感官、直观、高自由度假肢系统，可提高生活质量和 为失去上肢的退伍军人提供选择。

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.