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

评估和启用SCI后脊髓运动功能的治疗诊断工具 神经赋能技术公司 研究及相关其他项目信息 7.项目摘要 在美国大约1000万瘫痪患者中，15,000人是脊髓损伤的结果。 年第一年的护理费用从322，000美元到986，000美元不等，25岁受伤的人的终身费用为140万至400万美元 岁的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 在全国范围内，医疗保健，治疗和生产力损失将达到135.5亿美元。直到最近，从脊髓中恢复 损伤（SCI）是暗淡的，几乎没有希望恢复运动功能。为了解决这个问题，我们已经证明， 大鼠和猫的脊髓回路的生理状态可以用硬膜外刺激来调制，以产生自主神经刺激。 肢体运动功能在一定范围的速度、负荷和方向上，我们已经将这一发现扩展到人类。三年 损伤后，在运动完全脊髓损伤的人类受试者的脊髓上植入硬膜外电极阵列。 腰骶脊髓植入后不到一个月，受试者可以独立站立，7个月后， 月的日常硬膜外刺激和运动训练，双腿的自主控制是明显的， 硬膜外刺激，而完全瘫痪仍然在没有硬膜外刺激。我们将推进这些 使用腰骶髓的非侵入性刺激来改善下肢功能的发现， SCI.这项建议的核心是我们发现了一种无痛的电多通道（刺激大脑的多个部位）。 脊髓）治疗诊断工具，其可以应用于皮肤表面，称为经皮脊髓电 刺激（TESCS），绕过了对植入式电极阵列的需要。在本提案的第一阶段，我们 将证明腰骶脊髓刺激可以评估备用脊髓运动功能的原理证明 通过：1）测试脊髓损伤受试者对经皮电刺激的反应; 2）定义 使用机器学习协议最有效的电刺激的操作参数，以及3） 生产多通道商业样机。该商业产品将接受类似于 原理装置然后将在颈胸脊髓损伤受试者中测试该器械，并使用 机器学习协议第一阶段的提案将提供一种设备，可以无痛和非侵入性地帮助 通过向腰骶脊髓提供特定的电刺激范例， 改善下肢的使用。

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.