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

项目主任/首席调查员(最后、第一、中间)：FIELD-FOTE，Edelle Carmen 项目摘要/摘要 虽然脊髓损伤(SCI)的发生率可能没有其他神经疾病高，如 中风，许多患有脊髓损伤的人是年轻人，他们有望与残疾生活35-50年。因为这个原因， 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， SCI后的生活质量和社会参与。痉挛对脊髓损伤患者来说可能是一个严重的问题， 例如，与痉挛相关的肌肉痉挛可能非常强烈，即使有足够的运动 使用轻便手动轮椅的功能，有些人必须用笨重的动力固定 坐在椅子上，避免被痉挛从椅子上摔下来。痉挛的管理是具有挑战性的；它是 通常使用作为中枢神经系统抑制剂的抗痉挛药治疗，具有负面副作用 如嗜睡、嗜睡和肌肉无力。除了痉挛，许多脊髓损伤患者还有 神经性疼痛。痉挛和疼痛是除标志的肌肉麻痹之外的问题。 关于SCI的。TSS提供了一种可访问的方法来实现同时激活多个脊柱节段， 调节作为痉挛、疼痛和运动功能基础的脊髓神经回路。建议进行的研究 经皮脊髓刺激(TSS)对脊髓损伤后痉挛、疼痛和运动功能的校准 有可能对这些问题产生有意义的影响。TSS可能会提供有价值的 临床上可获得的神经调节形式，其好处是提供：1)非药理学 治疗痉挛的方法，2)治疗疼痛的非药物干预，以及3) 改善脊髓损伤患者意志运动功能的策略。然而，在TSS可以被认为是 临床可获得的神经调节的可行形式，需要对剂量反应有很多了解 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。这些研究将成为更大规模研究的基础 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50 HzTSS治疗痉挛的早期和晚期影响 3种不同强度(0.8xRT、0.8xRT-Burst、1.2xRT)中的每一种，以通知阶段2。 具体目标2(第二阶段；第二至第五年)量化早期、后期、累积和持续的多期会议影响 3种不同TSS频率条件(30赫兹、50赫兹、80赫兹；在强度/模式下)的痉挛 具体目标3(第二阶段；第二年-第五年)量化三种不同TS对伤害性感觉的早期、晚期和持续性影响 频率条件(30赫兹、50赫兹、80赫兹) 具体目标4(第二阶段；第二至第五年)量化每次刺激、早期和持续的对下肢的影响 3种不同TSS频率(30 Hz、50 Hz、80 Hz)下的肌力和运动控制 OMB编号0925-0001/0002(01/18修订版批准至2020年3月31日)第1页续格式页