Peripheral Interfaces in Amputees to Restore Sensation

描述(由申请人提供)： 我们的手是我们探索和操纵环境的主要手段。它们执行数千个复杂的动作，没有意识的思考，甚至没有视觉上的注意。感觉反馈是这些复杂活动的关键要素。在肌电上肢假体中缺乏感觉反馈使流体和复杂的运动变得困难，并要求使用者在假肢上保持视觉注意力以执行即使是最简单的任务。在这个项目中，我们将通过在残留的上肢神经上植入非穿透性袖带电极来解决感觉反馈的需求。我们的中心假设是，用选择性、非穿透性袖带电极对残存的上肢神经进行直接神经刺激，可以在知觉手的多个位置产生分级感觉和本体感觉。此外，使用袖带电极恢复感觉反馈将减少假体使用过程中的视觉和认知负荷，改善功能性能，从而实现假体的具体化。在第一次资助的优点审查中，电极和刺激技术被开发出来，并为临床实施做好了充分的准备。FDA和当地IRB批准了在调查设备豁免IDE#G110043下对截肢者进行该系统的调查。第一个受试者于2012年5月植入。在第一个受试者中，通过19个主动接触的刺激在受试者的知觉手上产生了19个独特的感觉知觉位置。知觉和刺激参数的位置继续保持稳定，在本提案提交时已超过六个月。此外，通过调节刺激模式，可以在幻影上的每个位置产生几种感觉，包括压力、滑倒、刺痛和刺痛。我们第一次证明，周围神经刺激在肢体丧失患者的模体上的许多地方产生高度选择性的、稳定的和正常的感觉。本项目的目的是在五名受试者中研究这些结果，演示感觉反馈在家庭中的使用，并演示自然感觉反馈带来的更好的用法和体现感。我们与奥托·博克和衣架诊所有着牢固的工作关系，提供了一支坚实的团队，随时准备对退伍军人、受伤战士和整个上肢丧失社区产生重大而真实的影响。具体地说，这个项目的目标是：目标1：表征感官知觉。上肢周围神经刺激在幻肢上的一个以上位置引起分级的感觉，并且这种感觉至少稳定两年。目标2：展示功能改善。由袖带电极产生的稳定感觉将减少足够的假体控制所需的注意力和视觉负荷，并将改善功能表现。目标3：展示化身。袖带电极与施加在假肢上的物理刺激同步地产生稳定的感觉，从而实现假肢的具体化。目标4：设计和验证植入式刺激器 永久性的感觉恢复。为了接触到更多的人口，将需要一个完全植入的系统。虽然现在投资于完全植入的设备还为时过早，但刺激回路将在台式系统中开发，为未来的植入开发做准备。通过与奥托博克的合作，米开朗基罗AxonBus手腕系统将成为我们的假体开发平台。与Hanger诊所的合作将提供有价值的以患者为中心的指导，并接触到大量的候选者。随着所提出的工作的成功实施，我们预计由于通过周围神经的永久的、自然的感觉反馈，上肢假体的性能和用户体验将得到永久性的改善。

DESCRIPTION (provided by applicant): Our hands are the primary means by which we explore and manipulate our environment. They perform thousands of intricate movements without conscious thought or even visual attention. Sensory feedback is a critical element of these complex activities. Lack of sensory feedback in myoelectric upper limb prostheses makes fluid and complex motions difficult and requires the user to maintain visual attention on the prosthesis to perform even the simplest task. In this project, we will address the need for sensory feedback by implanting non-penetrating cuff electrodes on the residual upper limb nerves. Our central hypothesis is that direct nerve stimulation with selective, non-penetrating cuff electrodes on the residual upper limb nerves can elicit graded sensation and proprioception at multiple locations in the perceptual hand. Further, restoration of sensory feedback with cuff electrodes will reduce visual and cognitive load during prosthesis usage, improve functional performance, and result in embodiment of the prosthesis. In the first funded merit review, the electrode and stimulation technology was developed and fully prepared for clinical implementation. The FDA and local IRB approved investigation of the system in amputees under an investigational device exemption, IDE #G110043. The first subject was implanted in May of 2012. In the first subject, stimulation through 19 active contacts produced 19 unique locations of sensory perception on the subject's perceptual hand. The locations of the perception and the stimulation parameters continue to remain stable, which is more than six month at time of this proposal submission. Further, by modulating stimulation patterns, several perceptions can be produced at each location on the phantom, including pressure, slip, tingling, and pricking. We have, for the first time, shown peripheral nerve stimulation produces highly selective, stable, and normal sensory perception in many places on the phantom of the person with limb loss. The purpose of this project is to study these results in a full cohort of five subjects, demonstrate home use of sensory feedback, and demonstrate improved usage and sense of embodiment resulting from natural sensory feedback. We have a strong working relationship with Otto Bock and Hanger Clinic, providing a solid team poised to make a significant and real impact on veterans, wounded warriors, and the upper limb loss community, as a whole. Specifically, the aims for this project are: Aim 1: Characterize sensory perception. Upper extremity peripheral nerve stimulation elicits graded sensory perceptions in more than one location on the phantom limb and the perceptions are stable up to at least two years. Aim 2: Demonstrate functional improvement. Stable sensory perception elicited by cuff electrodes will reduce attention and visual load required for adequate prosthesis control and will improve functional performance. Aim 3: Demonstrate embodiment. Stable sensory perception elicited by cuff electrodes in synchrony with physical stimuli applied to the artificial limb will result in embodiment of the artificial limb. Aim 4: Design and verify an implantable stimulator for permanent sensory restoration. To reach a larger population, a fully implanted system will be required. While it is premature for investment in a fully implanted device, the stimulation circuity will be developed in a bench-top system to prepare for future implant development. In collaboration with Otto Bock, the Michelangelo AxonBus hand and wrist system will be our prosthesis development platform. Collaboration with Hanger Clinic will provide valuable patient-centric guidance and access to a substantial candidate pool. Following successful execution of the work proposed, we expect to show permanent improvement in upper limb prosthesis performance and user embodiment due to permanent, natural sensory feedback through peripheral nerves.