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: 10390351
• 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/10390351
• 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; 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; wireless

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，该项目解决了糖尿病退伍军人可用干预措施的差距。 周围神经病（DPN）是VHA中一种庞大且不断增长的慢性疾病人群。 糖尿病患者截肢的风险比一般人高10倍 人口我们期待着离散的，有意义的感觉，被认为是从 通过多触点外周神经袖带电极可以慢性地诱发缺失足 安装在膝盖以上的大腿神经的退伍军人与下肢损失，由于 DPN。我们预计这些电引起的感觉可以维持健康， 恢复残肢的弹性，并在日常活动中提供有意义的反馈。我们将 严格记录病史和用药史，以及正在进行的 植入组件的疾病，并期望志愿者能够良好耐受 临床并发症最少。 截肢者不太注意他们的脚，有可能出现影响皮肤的并发症， 由于常规假肢接受腔的使用，他们的残肢下面的组织。我们预计 通过神经刺激引起感觉， DPN肢体缺损退伍军人的残肢组织的健康，并使他们 对潜在的破坏性负载更有弹性。即循环和残肢组织健康 会得到改善，并发症的可能性也会随着修复而降低。 适当的感觉。因此，血液流量，温度， 经皮氧和其他潜在组织健康的指标，以及 幻痛的频率和严重性将由于这种独特的干预而改变。 感觉与假体与假体之间的物理相互作用有关， 神经刺激引发的环境也将改善站立平衡，步行 机械，整体信心和活动水平的退伍军人与下肢损失，由于 DPN。站立平衡和摇摆，以及适应挑战或变化的能力 环境，以及注意力的主观评估，平衡信心和恐惧， 在有和没有感觉刺激的情况下测量跌倒。我们进一步预计， 我们的感觉神经假体谁有DPN会发现它在家庭和社区的价值 如使用模式、总站立和行走时间以及 满足和努力。我们希望用户能够增加移动性，并更有效地科普 步态和平衡障碍。 我们将招募并登记总共五名新参与者，他们将接受手术治疗。 植入系统，并作为其自身的历史（植入前和植入后）和并发 (with并且没有感觉刺激）控制。感觉神经假体以前 由我们的小组为创伤性经胫骨截肢者开发的， 敏感的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输送刺激， 适当的强度对应于对脚的物理输入。成功 完成这一项目将产生所需的信息，以确定要求的 为因DPN而失去肢体的退伍军人设计适合的独立系统 用于更大规模的临床试验或商业赞助的项目。