Functional and Neuroprotective Effects of Restoring Lower Limb Sensation after Diabetic Peripheral Neuropathy

糖尿病周围神经病变后恢复下肢感觉的功能和神经保护作用

• 批准号: 10184521
• 负责人: RONALD J TRIOLO
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10184521
• 关键词: Address; Adverse event; Affect; Amputation; Amputees; Anatomy; Attention; Biomechanics; Blood Circulation; Blood flow; Charge; Chronic; Chronic Disease; Clinical; Clinical Trials; Communities; Complication; Cutaneous; Diabetes Mellitus; Diagnosis; Disease; Distal; Electrodes; Enrollment; Environment; Equilibrium; Equipment and supply inventories; Esthesia; Exhibits; Feasibility Studies; Feedback; Fiber; Floor; Frequencies; Funding; Gait; General Population; Goals; Health; Home; Immunologics; Impaired healing; Implant; Individual; Intervention; Intuition; Joints; Knee; Laboratories; Length; Limb structure; Location; Lower Extremity; Measures; Mechanics; Medical; Nerve; Operative Surgical Procedures; Oxygen; Pain; Participant; Pattern; Perception; Perfusion; Peripheral Nerves; Peripheral Nervous System Diseases; Personal Satisfaction; Phantom Limb Pain; Pharmaceutical Preparations; Physiological; Population; Prosthesis; Psychophysics; Recording of previous events; Regulation; Reporting; Risk; Sensory; Severities; Site; Skin; Spatial Distribution; Surgical incisions; System; Temperature; Thigh structure; Time; Tissue Viability; Tissues; Translating; Veterans; Walking; Weight; Wireless Technology; afferent nerve; daily functioning; design; diabetic; fear of falling; foot; functional outcomes; gait examination; high risk; implantation; improved; improved mobility; innovation; limb amputation; limb loss; neural stimulation; neuroprosthesis; novel; preimplantation; pressure; prosthesis wearer; prosthetic socket; recruit; relating to nervous system; residual limb; residual limb health; resilience; restoration; satisfaction; sciatic nerve; sensory input; volunteer

Thus project addresses a gap in the available interventions for Veterans with Diabetic Peripheral Neuropathy (DPN), a large and growing chronic disease population within the VHA. Individuals with diabetes have a 10-times higher risk of amputations than the general population. We expect that discrete, meaningful sensations perceived to be arising from the missing foot can be chronically elicited by multi-contact peripheral nerve cuff electrodes installed on the nerves in the thigh above the knee of Veterans with lower-limb loss due to DPN. We anticipate that these electrically elicited sensations can maintain the health and resiliency of the residual limb and provide meaningful feedback during daily activities. We will rigorously document medical and medication history, and the interactions of the ongoing disease with the implanted components, and expect them to be well tolerated by volunteers with minimal clinical complications. Amputees pay less attention to their feet, are at risk for complications affecting the skin and underlying tissues of their residual limb due to routine prosthetic socket use. We expect that eliciting sensation perceived as arising from the missing foot via neural stimulation will improve the health of the residual limb tissues of Veterans with limb loss due to DPN, and make them more resilient to potentially damaging loads. That is, circulation and residual limb tissue health will improve, and the likelihood of developing complications will decrease with the restoration of appropriate sensation. Therefore, physiological measures of blood flow, temperature, transcutaneous oxygen and other indicators of underlying tissue health, as well as the and frequency and severity of phantom pain will change as a result of this unique intervention. The sensations perceived as related to physical interactions of the prosthesis with the environment elicited with neural stimulation will also improve standing balance, walking mechanics, and overall confidence and activity levels of Veterans with lower-limb loss due to DPN. Standing balance and sway, and the ability to adapt to challenging or changing environments, as well as subjective assessments of attention, balance confidence and fear of falling measured with and without sensory stimulation. We further anticipate that recipients of our Sensory Neuroprosthesis who have DPN will find it valuable in the home and community as evidenced by patterns of usage, total standing and walking time, and subjective ratings of satisfaction and effort. We expect users to have increased mobility, and cope more effectively with disturbances to gait and balance. We will recruit and enroll a total of five new participants who will receive the surgically implanted systems, and act as their own historical (pre- and post-implantation) and concurrent (with and without sensory stimulation) controls. The Sensory Neuroprosthesis previously developed by our group for traumatic trans-tibial amputees consisting of a wireless pressure sensitive insole and external neural stimulator will be adapted for the unique clinical needs of Veterans with DPN to deliver stimulation to the nerve via selected nerve electrode contacts at the appropriate intensity corresponding to physical input to the foot. The successful completion of this project will yield the information required to define the requirements for the design of a self-contained system for Veterans with limb loss due to DPN that will be suitable for larger scale clinical trials or commercially-sponsored projects.

因此，该项目解决了患有糖尿病的退伍军人可用干预措施的空白 周围神经病 (DPN) 是 VHA 内一个庞大且不断增长的慢性疾病群体。 糖尿病患者截肢的风险比一般人高10倍 人口。我们期望离散的、有意义的感觉被认为是由 多接触周围神经袖带电极可长期诱发足部缺失 安装在由于退伍军人的原因而导致下肢丧失的退伍军人膝盖以上大腿的神经上 DPN。我们预计这些电引起的感觉可以维持健康和 残肢的弹性并在日常活动中提供有意义的反馈。我们将 严格记录医疗和用药史，以及正在进行的相互作用 植入组件引起的疾病，并期望志愿者能够良好耐受 临床并发症极少。 截肢者不太注意自己的脚，有出现影响皮肤的并发症的风险 由于常规假肢接受腔的使用，残肢的底层组织受到影响。我们期望 通过神经刺激引发因缺失脚而产生的感觉将会改善 因 DPN 导致肢体丧失的退伍军人残肢组织的健康状况，并使他们 对潜在破坏性负载更具弹性。即循环和残肢组织健康 会有所改善，并且随着修复，发生并发症的可能性会降低 适当的感觉。因此，血流量、温度、 经皮氧气和其他底层组织健康指标，以及 这种独特的干预措施将改变幻痛的频率和严重程度。 与假肢与身体的物理相互作用相关的感觉 神经刺激引起的环境也会改善站立平衡、行走 由于以下原因导致下肢丧失的退伍军人的力学、整体信心和活动水平 DPN。站立平衡和摇摆，以及适应挑战或变化的能力 环境以及对注意力的主观评估，平衡信心和恐惧 在有或没有感官刺激的情况下测量跌倒。我们进一步预计接收者 拥有 DPN 的感觉神经假体会发现它在家庭和社区中很有价值 通过使用模式、总站立和行走时间以及主观评分来证明 满足感和努力。我们希望用户能够增强移动性，并更有效地应对 步态和平衡障碍。 我们将招募并招募总共五名新参与者，他们将接受手术 植入的系统，并充当自己的历史（植入前和植入后）和并发 （有或没有感官刺激）控制。之前的感觉神经假体 由我们团队为创伤性经胫骨截肢者开发，包括无线压力 敏感鞋垫和外部神经刺激器将适应独特的临床需求 患有 DPN 的退伍军人通过选定的神经电极触点向神经提供刺激 与足部物理输入相对应的适当强度。成功者 该项目的完成将产生定义需求所需的信息 为因 DPN 导致肢体丧失的退伍军人设计一个适合的自给式系统 用于更大规模的临床试验或商业赞助的项目。