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，项目解决了糖尿病退伍军人的可用干预措施的差距 周围神经病（DPN），VHA内的大而增长的慢性疾病人群。 糖尿病患者的截肢风险比一般高10倍 人口。我们期望这种离散的，有意义的感觉会源于 可以通过多连接外围神经袖口电极长期引起缺失的脚 安装在退伍军人膝盖上方的大腿上的神经上，由于 DPN。我们预计这些电气引起的感觉可以维持健康， 残留肢体的弹性，并在日常活动中提供有意义的反馈。我们将 严格记录医学和药物病史，以及正在进行的相互作用 带有植入成分的疾病，并期望它们能够得到志愿者的良好耐受性 临床并发症最小。 截肢者对脚的关注更少，面临影响皮肤和的并发症的风险 由于常规的假肢使用，其残留肢体的基础组织的基础组织。我们期望这一点 引起因缺失的脚部神经刺激而引起的感觉会改善 由于DPN引起的肢体损失的退伍军人的残留肢体组织的健康 对潜在损害负载的弹性更大。也就是说，循环和残留的肢体组织健康 会有所改善，随着修复的恢复，发展并发症的可能性将降低 适当的感觉。因此，血流，温度的生理测量 经皮氧和其他组织健康以及其他指标以及 由于这种独特的干预，幻影疼痛的频率和严重程度将改变。 感知与假体的物理相互作用有关的感觉 神经刺激引起的环境也将改善站立平衡，步行 机械师以及由于较低LIMB损失的退伍军人的整体信心和活动水平 DPN。站立平衡和摇摆，以及适应挑战或改变的能力 环境以及对关注，平衡信心和恐惧的主观评估 跌落以有或没有感觉刺激的情况下测量。我们进一步期望接收者 我们拥有DPN的感官神经假体在家庭和社区中都很有价值 通过使用模式，全面站立时间和步行时间以及主观评级来证明 满足和努力。我们希望用户提高移动性，并更有效地应对 与步态和平衡的干扰。 我们将招募和注册五名新参与者，他们将通过外科手术接受这一 植入系统，充当其自己的历史（植入前后）和并发 （带有和没有感觉刺激）对照。先前的感觉神经假体 由我们的小组开发用于由无线压力组成的创伤性跨腹膜截肢器 敏感的鞋垫和外部神经刺激器将适应独特的临床需求 具有DPN的退伍军人通过选定的神经电极接触向神经传递刺激 适当的强度对应于脚的物理输入。成功 该项目的完成将产生定义要求的信息 DPN造成的肢体损失的退伍军人的独立系统设计，这将是合适的 用于大规模的临床试验或商业化的项目。