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

项目摘要：K01 NINDS奖将为Yohannes Woldeamanuel博士提供密集的，有监督的 培训，以帮助他成为一个独立的研究科学家，专注于头痛医学，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。使用此K01奖， 博士Woldeamanuel将得到必要的支持，以完成以下目标：（a）成为熟练的临床 涉及控制偏头痛的行为干预的试验，（B）统计和生物信息学方法的培训， (c)获得质谱，分析和定量的熟练程度，（d）发展活动和奖学金 旨在职业发展目标成为一名独立调查员。为了实现这些目标，博士。 Woldeamanuel组建了一个导师团队：Robert科万博士（初级导师），Oxana Palesh博士（合作导师）， 导师），Jamie Zeitzer（联合导师），Michael Snyder（联合导师），Ying Lu（顾问），Allis Chien（顾问）。 研究：越来越多的偏头痛患者更喜欢非药物治疗方案，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导致的治疗。目前，没有直接证据表明 展示常规生活方式行为（RLB，即有规律的睡眠、锻炼、进餐时间）的效用， 慢性偏头痛本建议是首次就按区拨款计划在管理方面的可行性及试验性研究， 慢性偏头痛使用以下具体目标。主要目的：确定以下方法的可行性和可接受性 慢性偏头痛患者的RLB。次要目的：检查RLB在管理 慢性偏头痛，通过每月偏头痛天数的减少来测量。机械探索目的：检查 预测慢性偏头痛患者的候选生物标志物，这些患者是RLB应答者。发展，试点 测试和验证基于RLB的偏头痛治疗将在头痛领域产生积极的影响， 制定有效的基于生活方式的自我管理协议的框架。通过展示给 与日常药物等效，生活方式药物可以具有避免药物风险的附加价值 以及慢性偏头痛患者常见的不良副作用。该研究具有创新性 因为它的成功完成将试点测试一种新的方法，利用RLB作为自我管理工具， 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机制， RLB疗法的机制。系统生物学技术的应用将创造一个范式转变， 令人头痛研究集中在单个分子上。这一做法将在头痛医头、脚痛医脚中开先河 该领域提供了基于个性化生活方式的方案可用于管理偏头痛的原理证明。 这项研究将成为K奖结束前R01申请全面临床试验的基础。

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.