Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

项目总结：这个K01 NINDS奖将为Yohannes Woldeamanuel博士提供密集的、有监督的 培训帮助他成为一名独立的研究科学家，专注于头痛药物，更具体地说 使用促进健康的生活方式行为(例如，定期锻炼)来管理偏头痛。利用这个K01奖， Woldeamanuel博士将获得必要的支持，以完成以下目标：(A)掌握临床技能 涉及行为干预以控制偏头痛的试验，(B)统计和生物信息学方法方面的培训， (C)精通质谱学、分析和定量，(D)开展活动和提供奖学金 瞄准职业发展目标，成为一名独立的调查员。为了实现这些目标，Dr。 Woldeamanuel组建了一支导师团队：Robert Cowan博士(主要导师)，Oxana Palesh(联合导师) Mentor)、Jamie Zeitzer(共同导师)、Michael Snyder(共同导师)、Ying Lu(顾问)、Allis Chien(顾问)。 研究：越来越多的偏头痛患者倾向于非药物治疗选择，并经常停止药物治疗 由于不良反应、依从性差和费用问题而进行的治疗。目前，没有直接证据表明 展示有规律的生活方式行为(RLB，即有规律的睡眠、锻炼、用餐时间)管理的效用 慢性偏头痛。这项建议是第一次对注册银行在管理方面进行可行性和中试研究。 慢性偏头痛使用以下具体目标。主要目的：确定以下项目的可行性和可接受性 慢性偏头痛患者的RLB。次要目的：检验RLB在管理中的初步效果 通过每月偏头痛天数的减少来衡量慢性偏头痛。机械探索性目标：检验 预测慢性偏头痛患者的候选生物标记物，这些患者是RLB反应者。开发、试点 测试和验证基于RLB的偏头痛疗法将在头痛领域产生积极影响，因为 开发有效的基于生活方式的自我管理协议的框架。通过将其演示给 生活方式药物等同于日常药物，具有避免用药风险的附加值。 以及慢性偏头痛患者常见的不良副作用。建议的研究具有创新性。 因为它的成功完成将对一种新的方法进行试点测试，该方法利用RLB作为一种自我管理工具 治疗偏头痛。此外，这项拟议的研究将使用多组学来阐明潜在的生物学 RLB治疗的机制。系统生物学技术的应用将从目前的模式转变为 头痛研究集中在单分子上。这种方法将是令人头疼的第一种方法 在提供个性化的基于生活方式的治疗方案可以用于治疗偏头痛的原则证明方面。 这项研究将为在K奖结束前应用R01进行全面的临床试验奠定基础。

Project Summary: This K01 NINDS Award will provide Dr. Yohannes Woldeamanuel with intensive, supervised training to help him become an independent research scientist focusing on headache medicine, more specifically on managing migraine using health-promoting lifestyle behaviors (e.g. regular exercise). Using this K01 Award, Dr. Woldeamanuel will get the support necessary to complete the following goals: (a) become skilled in clinical trials involving behavioral interventions to manage migraine, (b) train in statistical and bioinformatics methods, (c) to gain proficiency in mass spectrometry, assays, and quantification, (d) develop activities and scholarship aimed at career development goals to become an independent investigator. To achieve these goals, Dr. Woldeamanuel has assembled a team of mentors: Drs. Robert Cowan (Primary Mentor), Oxana Palesh (Co- Mentor), Jamie Zeitzer (Co-Mentor), Michael Snyder (Co-Mentor), Ying Lu (Advisor), Allis Chien (Advisor). Research: Increasingly, migraine patients prefer non-drug treatment options and often discontinue drug treatment due to adverse effects, poor compliance, and cost issues. Currently, there is no direct evidence demonstrating the utility of regular lifestyle behavior (RLB i.e. regular sleep, exercise, mealtime) to manage chronic migraine. This proposal is the first to conduct a feasibility and pilot testing study of RLB in managing chronic migraine using the following specific aims. Primary Aim: To determine the feasibility and acceptability of RLB in chronic migraine patients. Secondary Aim: To examine the preliminary efficacy of RLB in managing chronic migraine as measured by reduction in monthly migraine days. Mechanistic Exploratory Aim: To examine candidate biomarkers that predict chronic migraine patients who are RLB-responders. The development, pilot testing, and validation RLB-based migraine therapy will have a positive impact in the headache field by providing a framework for development of efficacious lifestyle-based self-management protocols. By demonstrating it to be equipotent to daily medications, lifestyle medicine can have the added value of obviating medication risks and unwanted side-effects common among chronic migraine sufferers. The proposed research is innovative because its successful completion will pilot test a novel method by utilizing RLB as a self-management tool in managing migraine. In addition, this proposed research will use multi-omics to elucidate underlying biological mechanisms of RLB therapy. Application of system biology technology will create a paradigm shift from current headache research concentrating on single molecule. This approach will be the first of its kind in the headache field in providing proof-of-principle that personalized lifestyle-based protocols can be used to manage migraine. This research will form the basis for an R01 application of a full-scale clinical trial before the end of the K award.