Calibrating Transcutaneous Spinal Stimulation for Spasticity, Pain, and Motor Function in SCI

校准 SCI 中痉挛、疼痛和运动功能的经皮脊髓刺激

• 批准号: 10116760
• 负责人: EDELLE C. FIELD-FOTE
• 金额: $ 42.2万
• 依托单位: SHEPHERD CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-27 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10116760
• 关键词: Address; Affect; Baclofen; Biomechanics; Central Nervous System Depressants; Cerebral Palsy; Chronic; Clinical; Dose; Drowsiness; Effectiveness; Electrophysiology (science); Foundations; Frequencies; Health; Human; Hyporeflexia; Impairment; Implant; Incidence; Individual; Interneurons; Intervention; Investigation; Late Effects; Leg; Lethargies; Lower Extremity; Manual wheelchair; Measures; Motor; Motor Neurons; Motor output; Movement; Multiple Sclerosis; Muscle; Muscle Contraction; Muscle Weakness; Neurologic; Neuromodulator; Nociception; Operative Surgical Procedures; Pain; Pain management; Paresis; Paresthesia; Participant; Patient Self-Report; Pattern; Persons; Pharmacologic Substance; Phase; Population; Principal Investigator; Production; Quality of life; Reflex action; Reporting; Respondent; Secure; Smooth Muscle; Spasm; Spasmolytics; Spinal; Spinal Cord; Spinal cord injury; Stretching; Stroke; Structure; Surveys; Testing; Traumatic Brain Injury; Volition; care burden; chronic pain; cost; disability; efficacy study; experience; improved; improved functioning; innovation; intervention refinement; light weight; motor control; motor impairment; muscle strength; nervous system disorder; neural circuit; neuroregulation; nociceptive response; painful neuropathy; programs; public health relevance; relating to nervous system; response; side effect; social engagement; spasticity; systematic review; young adult

Program Director/Principal Investigator (Last, First, Middle): FIELD-FOTE, Edelle Carmen PROJECT SUMMARY / ABSTRACT While the incidence of spinal cord injury (SCI) may not be as high as other neurological disorders such as stroke, many with SCI are young adults who can expect to live with disability for 35 – 50 years. For this reason, even small reductions of impairment and improvements in function can have a significant impact on health, quality of life, and social participation after SCI. Spasticity can be a significant problem for persons with SCI, for example, the muscle spasms associated with spasticity can be so strong that, despite having sufficient motor function to use a lightweight manual wheelchair, some individuals must be secured in a cumbersome power chair to avoid being thrown from the chair by their spasms. Management of spasticity is challenging; it is typically treated with antispasmodics that act as central nervous system depressants, with negative side-effects such as drowsiness, lethargy, and muscle weakness. In addition to spasticity, many individuals with SCI have neuropathic pain. The problems of spasticity and pain are in addition to the muscle paresis that is the hallmark of SCI. TSS offers an accessible approach to achieving activation of multiple spinal levels simultaneously, modulating the spinal neural circuits that underlie spasticity, pain, and motor function. The proposed studies Calibrating Transcutaneous Spinal Stimulation (TSS) for Spasticity, Pain, and Motor Function in SCI have the potential to make a meaningful impact on these problems. It is possible that TSS can offer a valuable, and clinically accessible form of neuromodulation with the benefits of providing a: 1) non-pharmacological approach for managing spasticity, 2) non-pharmacological intervention for management of pain, and 3) strategy to improve volitional motor function in persons with SCI. However before TSS can be considered a viable form of clinically accessible neuromodulation, much needs to be learned about dose-response relationships regarding intensity, frequency, and pattern of stimulation, and how these influence spasticity, nociceptive responses, and volitional motor output. These studies will be the foundation for larger studies comparing TSS to commonly prescribed pharmaceuticals, after completion of the following Aims: Specific Aim 1 (Phase 1; Year 1) Quantify early and late within-session effects on spasticity of 50Hz TSS applied at each of 3 different intensities (0.8xRT, 0.8xRT-burst, 1.2xRT) to inform Phase 2. Specific Aim 2 (Phase 2; Years 2–5) Quantify early, late, cumulative and persistent multi-session effects on spasticity of 3 different TSS frequency conditions (30Hz, 50Hz, 80Hz; at the intensity/pattern) Specific Aim 3 (Phase 2; Years 2–5) Quantify early, late, and persistent effects on nociception of 3 different TSS frequency conditions (30Hz, 50Hz, 80Hz) Specific Aim 4 (Phase 2; Years 2–5) Quantify per-stimulation, early, and persistent effects on lower extremity muscle strength and motor control of 3 different TSS frequency conditions (30Hz, 50Hz, 80Hz) OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page 1 Continuation Format Page

项目总监/首席研究员（最后，第一，中间）：野战，埃德尔·卡门（Edelle Carmen） 项目摘要 /摘要 虽然脊髓损伤的事件（SCI）可能不如其他神经系统疾病，例如 中风，许多患有SCI的人是年轻人，他们可以期望残疾人生活35至50年。为此原因， 即使是少量减少障碍和功能改善也会对健康产生重大影响， 科学后的生活质量和社会参与。对于患有SCI的人来说，痉挛可能是一个重要的问题 例如，与痉挛相关的肌肉痉挛可能是如此之强，以至于具有足够的电动机 使用轻巧的手动轮椅的功能，某些人必须以繁琐的力量固定 椅子以避免被痉挛从椅子上扔掉。痉挛管理是具有挑战性的；这是 通常用充当中枢神经系统抑制剂的反杂质治疗，负面副作用 例如嗜睡，嗜睡和肌肉无力。除痉挛外，许多SCI的人都有 神经性疼痛。痉挛和疼痛的问题是肌肉减少的补充 科学。 TSS提供了一种可访问的方法，可以简单地实现多个脊柱水平的激活 调节脊柱中性电路，其痉挛，疼痛和运动功能是基础的。提出的研究 校准经皮脊柱刺激（TSS），用于SCI中的痉挛，疼痛和运动功能 对这些问题产生有意义影响的潜力。 TSS可能会提供有价值的，并且 临床上可访问的神经调节形式，其优势是：1）非药物 管理痉挛的方法，2）疼痛管理的非药理学干预，3） 改善SCI人的自愿运动功能的策略。但是，在TSS可以视为 可行的临床上可访问神经调节形式，有关剂量反应需要很多学习 有关强度，频率和模式的关系，以及这些关系如何影响痉挛， 伤害性响应和自愿电动机输出。这些研究将成为大型研究的基础 在完成以下目的后，将TSS与常规药品进行比较： 特定的目标1（阶段1; 1年）量化了对应用50Hz TSS痉挛的早期和晚期的影响 在3个不同的强度（0.8xrt，0.8xrt-Burst，1.2XRT）中，每一个都在阶段2通知。 特定目标2（第2阶段； 2 - 5年）量化了早期，晚期，累积和持续的多协议对 3种不同TSS频率条件的痉挛（30Hz，50Hz，80Hz；在强度/模式下） 特定目标3（阶段2； 2 - 5年）量化了早期，晚期和持续的对3种不同TSS伤害感受的影响 频率条件（30Hz，50Hz，80Hz） 特定目标4（第2阶段； 2 - 5年）量化了对下肢的每刺，早期和持续的影响 3种不同TSS频率条件的肌肉强度和运动控制（30Hz，50Hz，80Hz） OMB No. 0925-0001/0002（修订版01/18通过03/31/2020批准）Page 1延续格式页面