Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans with Mild Traumatic Brain Injury and Chronic Pain

对患有轻度创伤性脑损伤和慢性疼痛的退伍军人进行神经调节和瑜伽联合干预的可行性

• 批准号: 10282457
• 负责人: Amy Herrold
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10282457
• 关键词: Address; Afghanistan; Behavior Therapy; Brain; Breathing Exercises; Chronic; Clinical; Clinical Practice Guideline; Clinical Trials; Cognition; Common Data Element; Complementary Health; Conflict (Psychology); Data; Effectiveness; Foundations; Frequencies; Future; Goals; Health; High Prevalence; Hospitals; Impairment; Integrative Medicine; Intervention; Interview; Iraq; Knowledge; Lead; Literature; Logistics; Meditation; Mental Health; Military Personnel; Motor Cortex; National Institute of Neurological Disorders and Stroke; Nervous System Trauma; Neuronal Plasticity; Neuropathy; Opioid; Outcome; Pain; Pain intensity; Participant; Patient Self-Report; Pattern; Persons; Pilot Projects; Prevalence; Quality of life; Randomized Controlled Trials; Rehabilitation Outcome; Research; Risk; Safety; Sample Size; Sampling; Services; Stretching; Structure; TBI Patients; TBI treatment; Testing; Time; Transcranial magnetic stimulation; Traumatic Brain Injury; United States; Veterans; Yoga; acceptability and feasibility; base; chronic pain; chronic pain management; cohort; design; effective therapy; evidence base; implementation efforts; improved; mild traumatic brain injury; mindfulness; neurological rehabilitation; neuroregulation; non-opioid analgesic; novel; opioid epidemic; opioid therapy; opioid use disorder; pain outcome; pain reduction; physical conditioning; programs; psychoeducation; repetitive transcranial magnetic stimulation; satisfaction; treatment effect; treatment-resistant depression

Over 340,000 people have incurred a mild traumatic brain injury (mTBI) as a result of the military conflicts in Iraq and Afghanistan. mTBI leads to a host of poor rehabilitation outcomes including impairments in cognition, physical health, and psychological health. These impairments among people with TBI lead to poor quality of life (QOL). Worsening this clinical picture, the prevalence of chronic pain is estimated to be 51.5% among civilians with TBI and 43.1-70% among Veterans with TBI. Opioids are used for treating chronic pain including among people with TBI. Thus, given the ongoing opioid epidemic in the United States, it is very timely to develop alter- native, non-pharmacologic treatments for chronic pain among Veterans with mTBI. Yoga is a promising activ- ity-based intervention for TBI and chronic pain. Yoga is an activity generally comprised of breathing exercises, gentle stretching, and meditation. Neuromodulation through transcranial magnetic stimulation (TMS) is a prom- ising non-invasive, non-pharmacological treatment for TBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS shows promise to prime the brain for combined interventions and may magnify the impacts that these interventions would have when used alone, in order to boost outcomes. The purpose of this SPiRE project is to develop a novel, combined neuromodulation and yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain, and to examine the inter- vention’s feasibility and acceptability. Using an existing, evidence-based, yoga program created specifically for people with TBI (LoveYourBrain Yoga), we will first develop a neurorehabilitation intervention that combines iTBS with yoga (iTBS+yoga), and then collect pilot data about its feasibility and acceptability. Aim 1 will de- velop a novel, combined iTBS+yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain. Aim 2 will examine the feasibility and acceptability of the iTBS+yoga intervention for Veterans with mTBI and chronic pain. Aim 3 will gather preliminary data to provide the foundation for sample size and power considera- tions for a future clinical trial to examine the effectiveness of iTBS+yoga on Veterans’ quality of life, function and pain outcomes. The combined intervention will be provided in small group settings once a week for 6 weeks. iTBS will be administered immediately prior to the LoveYourBrain Yoga session. Emphasizing National Institute of Neurological Disorders and Stroke (NINDS) Traumatic Brain Injury Common Data Elements (TBI CDEs), we will collect preliminary outcome data related to quality of life, function and pain to inform a future Merit application, should the intervention prove feasible. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. TMS is now offered at 30 VA hospitals nationwide for treatment-resistant depression, and yoga is among the complementary and integrative health programs being rolled out as a part of VAs nation-wide Whole Health implementation efforts, with classes offered through VA service lines such as recreational therapy. Therefore, should iTBS+yoga ultimately prove to be efficacious and effective, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain, increased risk of opioid therapy, and increased risk of developing opioid use disorders.

年的军事冲突导致超过34万人遭受轻度创伤性脑损伤(MTBI) 伊拉克和阿富汗。MTBI导致一系列不良的康复结果，包括认知障碍， 身体健康和心理健康。脑外伤患者的这些损伤会导致生活质量下降 (QOL)。更糟糕的是，据估计，慢性疼痛在平民中的患病率为51.5% 在退伍军人中，有43.1%~70%的人患有脑损伤。阿片类药物用于治疗慢性疼痛，包括 患有脑外伤的人。因此，鉴于阿片类药物在美国的流行，现在开发替代药物是非常及时的。 患有mTBI的退伍军人慢性疼痛的本地、非药物治疗。瑜伽是一项很有前途的运动- 基于ITE的脑外伤和慢性疼痛的干预。瑜伽是一种通常由呼吸练习组成的活动， 温和的伸展和冥想。经颅磁刺激(TMS)的神经调节是一种PROM- 对脑外伤和慢性疼痛进行非侵入性、非药物治疗。间歇性theta爆发刺激 (ITBS)是一种图案化、兴奋性TMS。ITBS可以诱导神经可塑性窗口，使其成为理想的 适合于提高在此之后提供的治疗的效果。因此，ITBS展示了为大脑做好准备的前景 联合干预措施，并可能放大这些干预措施单独使用时的影响 以提高结果。这个尖顶项目的目的是开发一种新的、组合的神经调节 以及瑜伽神经康复干预对患有mTBI和慢性疼痛的退伍军人的影响，并检查 发明的可行性和可接受性。使用现有的、以证据为基础的、专门为 患有脑损伤(LoveYourBrain Yoga)的人，我们将首先开发一种结合了 ITBS和瑜伽(ITBS+瑜伽)，然后收集关于其可行性和可接受性的试点数据。目标一号将去- 为患有脑外伤和慢性疼痛的退伍军人开发一种新颖的、结合了ITBS和瑜伽的神经康复干预措施。 目标2将检查ITBS+瑜伽干预退伍军人合并mTBI的可行性和可接受性 慢性疼痛。AIM 3将收集初步数据，为样本规模和功率考虑提供基础- 关于未来临床试验的建议，以检验ITBS+瑜伽对退伍军人生活质量、功能的有效性 以及疼痛的结果。联合干预将在小组环境中提供，每周一次，共6次 几周。ITBS将在LoveYourBrain瑜伽课程之前立即实施。强调国家性 神经疾病和中风研究所(NINDS)创伤性脑损伤通用数据元素(TBI) ，我们将收集与生活质量、功能和疼痛相关的初步结果数据，以告知未来 如果干预被证明是可行的，那么就值得申请。这个尖顶项目将直接惠及退伍军人和 退伍军人重型颅脑损伤的非药物神经康复治疗 以及需要非阿片类药物治疗的慢性疼痛。TMS目前在全国30家退伍军人医院提供 难治性抑郁症，瑜伽是补充和综合的健康计划之一 作为VAS全国整体健康实施工作的一部分推出，通过退伍军人管理局提供课程 娱乐治疗等服务线。因此，如果ITBS+瑜伽最终被证明是有效的和 有效的，退伍军人管理局将做好准备提供这种治疗。一种新颖的、基于活动的、非药理学的 鉴于慢性疼痛的高患病率，对患有mTBI和慢性疼痛的退伍军人非常需要治疗， 增加阿片类药物治疗的风险，并增加发生阿片类药物使用障碍的风险。