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）：一种疗法工具，用于评估和启用Sci Neuroenabering Technologies，Inc。研究及相关的其他项目信息7。美国瘫痪大约1000万人的项目摘要。第一年 护理的价格从322,000美元至986,000美元不等，25岁受伤的人的终身费用为14-40万美元。除了可能造成毁灭性的感觉运动障碍外，还有巨大的经济成本，估计在全国范围内的医疗保健，治疗和生产力下降的费用为13.55亿美元。直到最近，从脊髓损伤（SCI）中恢复了惨淡，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，可以通过硬膜外刺激调节大鼠和猫的脊柱回路的生理状态，以在一系列速度，载荷和方向上产生自愿性的肢体运动功能，这一发现我们已扩展到人类。伤害后三年，马达完全脊髓受伤的人类受试者在腰椎脊髓上植入硬膜外电极阵列。在植入后不到一个月的时间里，受试者可以独立站立，在每天7个月进行硬膜外刺激和运动训练后，在存在硬膜外刺激的情况下，对双腿的自愿控制显而易见，而在没有硬膜外刺激的情况下仍保持完全麻痹。我们将通过使用非侵入性刺激腰椎绳来提高这些发现，从而在SCI后提高下肢功能。该提案的核心是我们发现了无痛的多通道（刺激脊髓的多个部分）近抑制剂工具，该工具可以应用于皮肤表面，称为皮肤脊髓电刺激（TESC），绕开了对外拟化学电子电极阵列的需求。在本提案的第一阶段，我们将证明原则上的证明，腰椎脊髓的刺激可以通过以下方式评估保存的脊髓运动功能：1）测试对脊髓损伤受试者的经皮电刺激的反应； 2）定义使用机器学习方案最有效的电刺激的操作参数，3）产生多通道商业原型。该商业产品将经过类似于原理设备的测试。然后，将在具有宫颈胸骨损伤的受试者中测试该设备，并通过机器学习方案进行评估。该阶段I建议将通过将特定的电刺激范式传递到腰s骨线，从而改善下肢的使用，从而无痛苦和非侵入性地帮助评估和恢复SCI的设备。