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

一种用于评估和启用 SCI 后备用脊髓运动功能的治疗诊断工具

• 批准号: 8735147
• 负责人: REGGIE EDGERTON
• 金额: $ 34.62万
• 依托单位: NEUROENABLING TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8735147
• 关键词: Address; Age-Years; Algorithms; American; Ankle; Bypass; Caring; Cervical; Cervical spinal cord injury; Chest; Chronic; Clinic; Clinical; Clinical Trials; Data; Devices; Diagnosis; Diagnostic; Electric Stimulation; Electrodes; Enrollment; Evaluation; Felis catus; Financial cost; Goals; Hip region structure; Human; Implant; Implanted Electrodes; Individual; Injury; Intervention; Joints; Knee; Leg; Life; Limb structure; Lower Extremity; Lumbar spinal cord structure; Machine Learning; Measurement; Medical; Modality; Motor; Movement; Nervous System Physiology; Neurologic; Neurostimulation procedures of spinal cord tissue; Outpatients; Painless; Paralysed; Paraplegia; Patients; Pharmaceutical Preparations; Phase; Physiological; Productivity; Protocols documentation; Rattus; Recovery; Residual state; Site; Skin; Speed; Spinal; Spinal Cord; Spinal Cord Part; Spinal Injuries; Spinal cord injury; Spinal cord injury patients; Stroke; Surface; Techniques; Technology; Testing; Therapeutic; Thoracic spinal cord structure; Time; Toes; Training; Transcutaneous Electric Nerve Stimulation; Translating; Upper Extremity; Weight-Bearing state; design; human subject; human subject protection; implantation; improved; improved functioning; injured; life time cost; meetings; motor control; motor function improvement; neural circuit; neuroregulation; prototype; public health relevance; response; theranostics; tool; transcutaneous stimulation

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.

描述（由申请人提供）：评估和启用SCI后脊髓运动功能的治疗诊断工具NeuroEnabled Technologies，Inc.研究及相关其他项目信息7.在美国约有1000万瘫痪患者中，每年有15，000人是脊髓损伤的结果。第一年 护理费用从322，000美元到986，000美元不等，25岁受伤者的终身费用为140万至400万美元。除了潜在的破坏性感觉运动障碍外，还有巨大的经济成本，估计全国范围内的医疗保健，治疗和生产力损失为135.5亿美元。直到最近，脊髓损伤（SCI）的恢复仍然是暗淡的，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，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，以在一定范围的速度，负荷和方向上产生随意肢体运动功能，我们已经将这一发现扩展到人类。损伤后三年，在运动完全脊髓损伤的人类受试者的腰骶脊髓上植入硬膜外电极阵列。在植入后不到一个月内，受试者可以独立站立，并且在每天硬膜外刺激和运动训练7个月后，在硬膜外刺激存在下双腿的自主控制明显，而在没有硬膜外刺激的情况下完全瘫痪。我们将通过对腰骶髓的非侵入性刺激来改善SCI后的下肢功能，从而推进这些发现。该提案的核心是我们发现了一种无痛电多通道（刺激脊髓的多个部分）治疗诊断工具，该工具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通过以下方式评估备用脊髓运动功能的原理证明：1）测试脊髓损伤受试者对经皮电刺激的反应; 2）使用机器学习协议定义最有效的电刺激操作参数，3）生产多通道商业原型。该市售产品将接受与原理验证器械相似的试验。然后，该设备将在颈胸脊髓损伤受试者中进行测试，并使用机器学习协议进行评估。该第一阶段提案将提供一种设备，该设备可以通过向腰骶髓提供特定的电刺激范例来无痛和非侵入性地帮助SCI的评估和恢复，从而改善下肢的使用。