A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI

一种评估和启用脊髓损伤后备用脊髓运动功能的体视学工具 NeuroEnabling Technologies公司 研究及相关其他项目信息 7.项目总结 在美国约1000万瘫痪患者中，有15000人是脊髓损伤的结果 年。第一年的护理费用从32.2万美元到98.6万美元不等，25岁受伤的人一生的费用为140万美元到400万美元 几年前。除了可能具有破坏性的感觉运动干扰外，还有巨大的经济成本，估计 在全国范围内，医疗、治疗和生产力损失将达到135.5亿美元。直到最近，脊髓的恢复 损伤(SCI)是黯淡的，几乎没有恢复运动功能的希望。为了解决这个问题，我们已经证明了 大鼠和猫的脊髓回路的生理状态可以通过硬膜外刺激来调节，以产生自愿的 肢体运动在一系列速度、负荷和方向上都能发挥作用，这一发现我们已经推广到人类身上。三年 损伤后，将硬膜外电极阵列植入运动损伤的完全性脊髓损伤的人体受试者的 腰骶部脊髓。在植入后不到1个月的时间内，受试者可以独立站立，7个月后 几个月的每日硬膜外刺激和运动训练，双腿的自愿控制是明显的存在 硬膜外刺激，而完全瘫痪在没有硬膜外刺激的情况下仍然存在。我们将推进这些 使用非侵入性刺激腰骶髓改善患者术后下肢功能的发现 SCI。这一提议的核心是我们发现了一种无痛电多通道(刺激大脑的多个部位 脊髓)可应用于皮肤表面的治疗工具，称为经皮脊髓电 刺激(TESCS)，不需要外科植入的电极阵列。在这项建议的第一阶段，我们 将证明刺激腰椎脊髓可以评估备用的脊髓运动功能的原则 通过：1)测试脊髓损伤受试者对经皮电刺激的反应；以及2)确定 使用机器学习协议最有效的电刺激的操作参数，以及3) 生产多渠道商业原型。该商业产品将接受类似于- 原理装置。然后，该装置将在颈胸段脊髓损伤的受试者中进行测试，并进行评估 机器学习协议。这项第一阶段计划将提供一种设备，可以无痛和非侵入性地帮助患者 通过将特定的电刺激范例传递到腰骶髓来评估和恢复脊髓损伤 改善了对下肢的使用。

A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI NeuroEnabling Technologies, Inc. RESEARCH & RELATED Other Project Information 7. PROJECT SUMMARY Of the approximately 10 million people in the US living with paralysis, 15,000 are the result of spinal cord injury each year. The first year of care can range from $322,000-$986,000, with lifetime costs of $1.4-4M for someone injured at 25 years of age. In addition to potentially devastating sensorimotor disturbances, there is a huge financial cost, estimated to be $13.55B in medical care, therapy, and lost productivity nationwide. Until very recently, the recovery from spinal cord injury (SCI) was bleak, with little hope of restoring motor function. To address this we have demonstrated that the physiological state of the spinal circuitry of rats and cats can be modulated with epidural stimulation to generate voluntary limb motor function over a range of speeds, loads, and directions, a finding we have extended to humans. Three years post-injury, a motor complete spinal cord injured human subject was implanted with an epidural electrode array over the lumbosacral spinal cord. In less than one month after implantation, the subject could stand independently, and after 7 months of daily epidural stimulation and motor training, voluntary control of both legs was evident in the presence of epidural stimulation, whereas complete paralysis remained in absence of epidural stimulation. We will advance these discoveries with the use of non-invasive stimulation of the lumbosacral cord to improve lower limb function following SCI. Central to this proposal is our discovery of a painless electrical multi-channel (stimulation of multiple parts of the spinal cord) theranostic tool that can be applied to the surface of the skin, termed transcutaneous spinal cord electrical stimulation (TESCS), bypassing the need for a surgically-implanted electrode array. In the first phase of this proposal we will demonstrate proof-of-principle that stimulation of the lumbosacral spinal cord can assess spared spinal motor function by: 1) Testing responses to transcutaneous electrical stimulation in subjects with spinal cord injury; and 2) defining the operational parameters of electrical stimulation that that are most effective using a machine-learning protocol, and 3) produce a multi-channel commercial prototype. This commercial product will undergo testing similar to the proof-of- principle device. This device will then be tested in subjects with cervicothoracic spinal cord injury and evaluated with a machine-learning protocol. This Phase I proposal will deliver a device that can painlessly and non-invasively aid in the assessment and recovery of SCI by delivering a specific electrical stimulation paradigm to the lumbosacral cord that improves use of the lower limbs.