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

慢性偏头痛行为干预的可行性、可接受性和试点测试

• 批准号: 10708137
• 负责人: Yohannes Woubishet Woldeamanuel
• 金额: $ 24.04万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708137
• 关键词: Adverse effects; Attention; Attenuated; Award; Behavior; Behavior Therapy; Bioinformatics; Biological; Biological Assay; CD44 Antigens; Chronic; Clinical; Clinical Trials; Coenzyme A; Cross-Sectional Studies; Development; Disease Management; Endowment; Exercise; Frequencies; Future; Glutathione; Goals; Headache; Health Promotion; Informal Social Control; Intervention; Intervention Studies; K-Series Research Career Programs; Life Style; Lifestyle Therapy; Mass Spectrum Analysis; Measures; Medicine; Mentored Research Scientist Development Award; Mentors; Methods; Migraine; National Institute of Neurological Disorders and Stroke; Outcome; Oxidative Stress; Participant; Patients; Perception; Pharmaceutical Preparations; Pharmacotherapy; Phenotype; Pilot Projects; Placebo Control; Proteomics; Protocols documentation; Provider; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Research; Research Design; Research Personnel; Risk; Role; Scholarship; Scientist; Self Efficacy; Self Management; Serum; Severities; Sleep; Systems Biology; Technology; Testing; Training; Validation; Vascular Permeabilities; acceptability and feasibility; adherence rate; allostatic load; arm; base; behavioral adherence; behavioral clinical trial; biobehavior; candidate marker; career development; cognitive control; comorbid depression; comparison control; coping; cost; design; efficacy testing; empowerment; feasibility testing; innovation; medication compliance; metabolomics; migraine treatment; multiple omics; neuroinflammation; neurotransmission; non-drug; nondrug therapy; novel; patient engagement; pilot test; predictive marker; prevent; prospective; recruit; satisfaction; side effect; single molecule; skills; tool; treatment as usual

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.

项目摘要：K01 NINDS 奖将为 Yohannes Woldeamanuel 博士提供强化的、受监督的 培训帮助他成为一名专注于头痛医学的独立研究科学家，更具体地说 使用促进健康的生活方式（例如定期锻炼）来控制偏头痛。利用这个K01奖， Woldeamanuel 博士将获得完成以下目标所需的支持：(a) 熟练掌握临床技能 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培训， (c) 熟练掌握质谱、分析和定量， (d) 开展活动和学术研究 旨在成为一名独立调查员的职业发展目标。为了实现这些目标，博士。 Woldeamanuel 组建了一个导师团队：博士。 Robert Cowan（主要导师）、Oxana Palesh（联合导师） 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，并且经常停药 由于不良反应、依从性差和费用问题而进行治疗。目前尚无直接证据 展示规律的生活方式行为（RLB，即规律的睡眠、锻炼、进餐）对管理的效用 慢性偏头痛。该方案首次对RLB在管理方面进行可行性和试点研究。 慢性偏头痛的具体使用目的如下。主要目标：确定可行性和可接受性 慢性偏头痛患者的 RLB。次要目标：检验 RLB 在管理方面的初步功效 慢性偏头痛通过每月偏头痛天数的减少来衡量。机制探索目标：检验 预测慢性偏头痛患者是否有 RLB 反应的候选生物标志物。开发、试点 测试和验证基于 RLB 的偏头痛疗法将通过提供以下功能对头痛领域产生积极影响： 制定有效的基于生活方式的自我管理协议的框架。通过演示它 与日常药物等效，生活方式医学可以具有消除药物风险的附加值 以及慢性偏头痛患者中常见的不良副作用。所提出的研究具有创新性 因为它的成功完成将试点测试一种利用 RLB 作为自我管理工具的新方法 管理偏头痛。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疗法的机制。系统生物学技术的应用将创造一个范式转变 头痛研究集中于单分子。这种方法将是首个解决头痛问题的方法 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验证。 这项研究将构成 K 奖结束前全面临床试验 R01 申请的基础。

项目成果

Computerized migraine diagnostic tools: a systematic review.

• DOI: 10.1177/20406223211065235
• 发表时间: 2022
• 期刊: Therapeutic advances in chronic disease
• 影响因子: 3.5
• 作者: Woldeamanuel YW;Cowan RP
• 通讯作者: Cowan RP

What is the efficacy of aerobic exercise versus strength training in the treatment of migraine? A systematic review and network meta-analysis of clinical trials.

• DOI: 10.1186/s10194-022-01503-y
• 发表时间: 2022-10-13
• 期刊: The journal of headache and pain