Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial.
Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial.
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DOI：
10.2196/37836
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发表时间：
2022-06-15
影响因子：
1.7
通讯作者：
Herrold, Amy A.
中科院分区：
文献类型：
--
作者：
Krese, Kelly A.;Donnelly, Kyla Z.;Etingen, Bella;Pape, Theresa L. Bender;Chaudhuri, Sarmistha;Aaronson, Alexandra L.;Shah, Rachana P.;Bhaumik, Dulal K.;Billups, Andrea;Bedo, Sabrina;Wanicek-Squeo, Mary Terese;Bobra, Sonia;Herrold, Amy A.
关键词：
轻度创伤性脑损伤 (mTBI) 和慢性疼痛经常同时发生，并使康复结果恶化。需要改进的多模式非药物治疗，以改善这两种疾病的结果。瑜伽是治疗 mTBI 和慢性疼痛的一种有前途的基于活动的干预措施，而通过颅磁刺激进行神经调节是一种有前途的 mTBI 和慢性疼痛的无创、非药物治疗方法。间歇性 theta 突发刺激 (iTBS) 是一种模式化的兴奋性经颅磁刺激。 iTBS 可以诱导神经可塑性窗口，使其非常适合增强其后提供的治疗效果。因此，与单独提供干预措施相比，iTBS 可能会放大随后提供的干预措施的影响，并相应地增强其对结果的影响。本研究的目的是 (1) 开发一种针对 mTBI 和慢性疼痛的 iTBS+瑜伽联合干预措施，(2) 评估干预措施的可行性和可接受性，以及 (3) 收集有关生活质量、功能和疼痛的初步临床结果数据，以指导未来的研究。这是一项混合方法、试点、开放标签、受试者内干预研究。我们将招募20名美国退伍军人参加。 iTBS+瑜伽联合干预将在小组环境中每周提供一次，持续 6 周。瑜伽干预将遵循专为 TBI 患者开发的 LoveYourBrain 瑜伽方案。 iTBS 将在 LoveYourBrain 瑜伽课程之前进行。我们将在干预前后收集与生活质量（TBI-生活质量）、功能（梅奥-波特兰适应性指数）和疼痛（简要疼痛量表）相关的初步定量结果数据，为更大规模的研究提供信息。我们将通过半结构化访谈收集定性数据，重点关注干预完成后的可接受性。该研究方案得到了小爱德华·海因斯退伍军人管理局医院机构审查委员会 (Hines IRB 1573116-4) 的批准，并在 ClinicalTrials.gov (NCT04517604) 上前瞻性注册。本研究包括食品和药物管理局研究设备豁免（IDE：G200195）。制定了两年研究计划时间表。截至 2022 年 3 月，共有 6 名退伍军人参加了这项研究。数据收集工作正在进行中，将于 2022 年 11 月完成。我们预计这项研究的结果将于 2024 年 10 月公布。我们将能够提供初步证据，证明新型 iTBS 和瑜伽联合干预治疗 mTBI 和慢性疼痛（治疗需求未得到满足）的安全性、可行性和可接受性。 ClinicalTrials.gov NCT04517604； https://www.clinicaltrials.gov/ct2/show/NCT04517604 DERR1-10.2196/37836
Mild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved multimodal nonpharmacologic treatments that could improve outcomes for both conditions. Yoga is a promising activity-based intervention for mTBI and chronic pain, and neuromodulation through transcranial magnetic stimulation is a promising noninvasive, nonpharmacological treatment for mTBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory transcranial magnetic stimulation. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS may magnify the impacts of subsequently delivered interventions as compared to delivering those interventions alone and accordingly boost their impact on outcomes. The aim of this study is to (1) develop a combined iTBS+yoga intervention for mTBI and chronic pain, (2) assess the intervention’s feasibility and acceptability, and (3) gather preliminary clinical outcome data on quality of life, function, and pain that will guide future studies. This is a mixed methods, pilot, open-labeled, within-subject intervention study. We will enroll 20 US military veteran participants. The combined iTBS+yoga intervention will be provided in small group settings once a week for 6 weeks. The yoga intervention will follow the LoveYourBrain yoga protocol—specifically developed for individuals with TBI. iTBS will be administered immediately prior to the LoveYourBrain yoga session. We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semistructured interviews focused on intervention acceptability after completion of the intervention. This study protocol was approved by Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4) and was prospectively registered on ClinicalTrials.gov (NCT04517604). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G200195). A 2-year research plan timeline was developed. As of March 2022, a total of 6 veterans have enrolled in the study. Data collection is ongoing and will be completed by November 2022. We expect the results of this study to be available by October 2024. We will be able to provide preliminary evidence of safety, feasibility, and acceptability of a novel combined iTBS and yoga intervention for mTBI and chronic pain—conditions with unmet treatment needs. ClinicalTrials.gov NCT04517604; https://www.clinicaltrials.gov/ct2/show/NCT04517604 DERR1-10.2196/37836
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影响因子：
1.5
作者：
Betthauser LM;Forster JE;Bortz A;Penzenik M;Hernández TD;Bahraini N;Brenner LA
通讯作者：
Brenner LA
DOI：
10.1016/s0140-6736(18)32335-3
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期刊：
Lancet (London, England)
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