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

描述(由申请人提供)：一种在SCI NeuroEnabling Technologies，Inc.研究和相关其他项目信息后评估和启用备用脊髓运动功能的Theranostic工具。7.项目摘要美国约有1000万瘫痪患者，每年有15,000人是脊髓损伤的结果。第一年 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。除了潜在的破坏性感觉运动障碍，还有巨大的经济成本，估计在医疗、治疗和全国范围内的生产力损失上花费135.5亿美元。直到最近，脊髓损伤(SCI)的恢复还很黯淡，恢复运动功能的希望微乎其微。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，以在一系列速度、负荷和方向上产生自愿的肢体运动功能，这一发现我们已经扩展到人类。损伤3年后，将一名运动性完全性脊髓损伤的受试者在腰骶段脊髓上植入硬膜外电极阵列。术后1个月内，受试者可以独立站立，经过7个月的日常硬膜外刺激和运动训练，在有硬膜外刺激的情况下，双腿自主控制明显，而在没有硬膜外刺激的情况下，完全瘫痪仍然存在。我们将通过使用非侵入性刺激腰骶髓来改善脊髓损伤后的下肢功能来推进这些发现。这项建议的核心是我们发现了一种无痛的多通道电刺激(刺激脊髓多个部分)治疗工具，可应用于皮肤表面，称为经皮脊髓电刺激(TESCS)，绕过了手术植入的电极阵列。在这项建议的第一阶段，我们将通过以下方式证明原则：刺激腰骶脊髓可以评估备用的脊髓运动功能：1)测试脊髓损伤受试者对经皮电刺激的反应；2)使用机器学习协议确定最有效的电刺激操作参数，以及3)产生多通道商业原型。这一商业产品将接受类似于原理证明装置的测试。然后，该设备将在颈胸段脊髓损伤的受试者中进行测试，并使用机器学习方案进行评估。这项第一阶段的提案将提供一种设备，通过向腰骶索提供特定的电刺激范例来改善下肢的使用，从而无痛和非侵入性地帮助评估和恢复脊髓损伤。

DESCRIPTION (provided by applicant): 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.