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

超过340，000人因军事冲突而遭受轻度创伤性脑损伤（mTBI）。 伊拉克和阿富汗mTBI导致许多不良的康复结果，包括认知障碍， 身体健康和心理健康。TBI患者的这些损伤导致生活质量低下 （QOL）。更糟糕的是，在平民中，慢性疼痛的患病率估计为51.5%， TBI和43.1-70%的退伍军人TBI。阿片类药物用于治疗慢性疼痛，包括 TBI患者因此，鉴于美国阿片类药物的流行，现在是非常及时的发展改变- mTBI退伍军人慢性疼痛的天然非药物治疗。瑜伽是一种很有前途的活动， TBI和慢性疼痛的基于城市的干预。瑜伽是一种活动，通常包括呼吸练习， 轻柔的伸展和冥想通过经颅磁刺激（TMS）进行神经调节是一种有效的方法。 为TBI和慢性疼痛提供非侵入性、非药物治疗。间歇性Theta爆发刺激 （iTBS）是一种模式化的兴奋性TMS。iTBS可以诱导神经可塑性窗口，使其成为理想的 因此，iTBS显示出有希望为大脑做好准备， 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， 以提高成果。这个SPiRE项目的目的是开发一种新的， 和瑜伽神经康复干预的退伍军人与mTBI和慢性疼痛，并检查间- 的可行性和可接受性。使用现有的，以证据为基础的瑜伽课程， 对于患有TBI（爱你的大脑瑜伽）的人，我们将首先开发一种神经康复干预， iTBS与瑜伽（iTBS+瑜伽），然后收集有关其可行性和可接受性的试点数据。目标1将- velop是一种新型的，结合iTBS+瑜伽神经康复干预的退伍军人与mTBI和慢性疼痛。 目标2将研究iTBS+瑜伽干预对mTBI退伍军人的可行性和可接受性， 慢性疼痛目标3将收集初步数据，为样本大小和功效评估提供基础。 未来的临床试验，以检查iTBS+瑜伽对退伍军人的生活质量，功能， 和疼痛结果。联合干预将在小组环境中提供，每周一次，持续6 周iTBS将在LoveYourBrain瑜伽课程之前立即进行。强调国家 神经疾病和中风研究所（NINDS）创伤性脑损伤通用数据元素（TBI CDE），我们将收集与生活质量、功能和疼痛相关的初步结果数据， 如果干预措施证明可行，则应适用功绩。这个SPiRE项目将直接使退伍军人受益， VA服务，为患有mTBI的退伍军人开发一种新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现已在全国30家退伍军人管理局医院提供， 治疗性抑郁症，瑜伽是补充和综合健康计划， 作为VA全国范围内的整体健康实施工作的一部分推出，通过VA提供课程 服务线，如休闲治疗。因此，iTBS+瑜伽是否最终被证明是有效的， 有效的，VA设施将做好准备提供这种治疗。一种新的、基于活性的、非药理学的 对于患有mTBI和慢性疼痛的退伍军人的治疗是非常需要的， 阿片类药物治疗的风险增加，以及发生阿片类药物使用障碍的风险增加。

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.