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: 10351573
• 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/10351573
• 关键词: Adverse effects; Attention; Attenuated; Award; Behavior; Behavior Therapy; Bioinformatics; Biological; Biological Assay; CD44 Antigens; Chronic; Clinical; Clinical Trials; Coenzyme A; Cognitive; Cross-Sectional Studies; Custom; Development; Disease; Exercise; 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; Regulation; Research; Research Design; Research Personnel; Risk; Role; Scholarship; Scientist; Self Efficacy; Self Management; Serum; Severities; Sleep; Supervision; Systems Biology; Technology; Testing; Training; Validation; Vascular Permeabilities; acceptability and feasibility; adherence rate; base; behavioral adherence; behavioral clinical trial; biobehavior; candidate marker; career development; comorbidity; cost; design; efficacy testing; empowered; innovation; medication compliance; metabolomics; multiple omics; neuroinflammation; neurotransmission; non-drug; nondrug therapy; novel; patient engagement; predictive marker; prevent; prospective; recruit; satisfaction; side effect; single molecule; tool; usual care arm

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.

项目概述：该K01 NINDS奖将为Yohannes Woldeamanuel博士提供密集的，有监督的