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: 10475583
• 负责人: EDELLE C. FIELD-FOTE
• 金额: $ 38.94万
• 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/10475583
• 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; biomechanical test; 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

项目负责人/主要研究者（最后，第一，中间）：FIELD-FOTE，Edelle Carmen 项目总结/摘要 虽然脊髓损伤（SCI）的发病率可能不像其他神经系统疾病， 许多SCI患者都是年轻人，他们可能会在残疾的情况下生活35 - 50年。基于这个理由， 即使是损伤的微小减少和功能的改善也会对健康产生重大影响， 生活质量和社会参与。痉挛可能是SCI患者的一个重要问题， 例如，与痉挛状态相关的肌肉痉挛可以如此强烈， 使用轻便的手动功能轮椅，有些人必须在一个笨重的权力保障 椅子上，以避免被抛出从椅子上的痉挛。痉挛的管理是具有挑战性的;它是 通常用抗痉挛药治疗，作为中枢神经系统抑制剂，有负面副作用 例如困倦、嗜睡和肌肉无力。除了痉挛，许多SCI患者还 神经性疼痛痉挛和疼痛的问题是除了肌肉麻痹，这是标志 SCI的。TSS为同时激活多个脊柱节段提供了一种可行的方法， 调节痉挛、疼痛和运动功能的脊髓神经回路。拟议的研究 校准经皮脊髓刺激（TSS）的痉挛，疼痛和运动功能在SCI有 对这些问题产生有意义影响的潜力。TSS有可能提供一个有价值的， 临床上可获得的神经调节形式，其益处在于提供：1）非药理学 管理痉挛状态的方法，2）管理疼痛的非药物干预，和3） 改善SCI患者意志运动功能的策略然而，在TSS被认为是 临床上可获得的神经调节的可行形式，需要了解更多关于剂量反应的信息 关于刺激强度、频率和模式的关系，以及这些如何影响痉挛， 伤害性反应和意志运动输出。这些研究将为更大规模的研究奠定基础 在完成以下目标后，将TSS与常用处方药进行比较： 具体目标1（第1阶段;第1年）量化早期和晚期对应用50 Hz TSS的痉挛状态的会话内影响 以3种不同强度（0.8xRT，0.8xRT-突发，1.2xRT）中的每一种来通知阶段2。 具体目标2（第2阶段;第2-5年）量化早期、晚期、累积和持续的多阶段效应， 3种不同TSS频率条件下的痉挛（30 Hz、50 Hz、80 Hz;强度/模式） 特定目标3（2期; 2-5年）量化3种不同TSS对伤害性感受的早期、晚期和持续影响 频率条件（30 Hz、50 Hz、80 Hz） 特定目标4（第2阶段;第2-5年）量化对下肢的每次刺激、早期和持续影响 3种不同TSS频率条件（30 Hz、50 Hz、80 Hz）的肌肉力量和运动控制 OMB编号0925-0001/0002（2018年1月修订版至2020年3月31日批准）第1页续格式第页