Randomized Double-Blind Placebo-Controlled Trial: fMRI Assessment of Cranial Electrical Stimulation for Fibromyalgia in Veterans

随机双盲安慰剂对照试验：功能磁共振成像评估退伍军人纤维肌痛的颅脑电刺激

• 批准号: 10680416
• 负责人: Anna Woodbury
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10680416
• 关键词: Acupuncture Therapy; Address; Affect; Aftercare; Age; American; Analgesics; Anxiety; Area; Autonomic nervous system; Award; Biological Markers; Board Certification; Brain; Brain region; Cephalic; Chronic; Clinical; Clinical Research; Clinical Trials; Complex; Consumption; Controlled Clinical Trials; Controlled Environment; Cranial Nerves; Data; Data Analyses; Dependence; Development; Development Plans; Devices; Diagnosis; Double-Blind Method; Ear; Educational Curriculum; Electric Stimulation; Environment; External Ear; FDA approved; Feasibility Studies; Female; Fibromyalgia; Foundations; Functional Magnetic Resonance Imaging; Functional disorder; Future; Gender; Goals; Grant; Gulf War; Gulf War veteran; Human Resources; Incidence; International; Investigation; Knowledge; Learning; Learning Skill; Long-Term Effects; Magnetic Resonance Imaging; Master of Science; Measurable; Measures; Mentors; Methods; Military Personnel; Moods; Nature; Nerve; Neuroanatomy; Neurocognitive; Neuronal Plasticity; Nonpharmacologic Therapy; Opioid; Outcome; Pain; Pain Measurement; Pain Research; Pain intensity; Pain management; Pain quality; Patient Self-Report; Patients; Placebo Control; Placebos; Prediction of Response to Therapy; Quality of life; Randomized; Registries; Research; Research Personnel; Rest; Rheumatology; Risk; Science; Scientist; Series; Sleep; Sleeplessness; Symptoms; Synapses; Syndrome; System; Techniques; Testing; Time; Training; Treatment outcome; Universities; Variant; Veterans; Visual; Visualization; Work; arm; biceps brachii muscle; career; career development; central pain; chronic pain; chronic pain management; chronic painful condition; clinical biomarkers; clinical pain; clinical predictors; college; double-blind placebo controlled trial; experience; experimental study; feasibility trial; fibromyalgia pain; fibromyalgia patients; follow-up; functional improvement; global health; imaging approach; improved; male; neural; neural correlate; neuroimaging; neuroimaging marker; neurophysiology; neurotransmission; non-opioid analgesic; novel; opioid epidemic; opioid sparing; opioid use; opioid withdrawal; pain outcome; pain processing; pain relief; predictive marker; primary outcome; responders and non-responders; secondary outcome; side effect; skills; symposium; tool; treatment effect; treatment response; trend

CANDIDATE: Dr. Woodbury is an 8/8 VA-paid employed double-board certified anesthesiologist and pain management clinician who seeks protected time to develop advanced neuroimaging and clinical trials expertise following successful completion of a CDA-1 feasibility study. ENVIRONMENT: The Center for Visual and Neurocognitive Research (CVNR) is a VA RR&D Center of Excellence (COE) in research and provides a robust clinical research environment in conjunction with nearby Emory University. RESEARCH PLAN: In the setting of the opioid epidemic, it is crucial to develop non-pharmacologic treatments for pain and biomarkers to accurately assess pain treatment outcomes. In the present investigation, we assess a novel non- pharmacologic approach to chronic pain treatment in patients suffering from fibromyalgia (a notoriously difficult to treat pain syndrome), utilizing neuroimaging as a biomarker. Resting state functional connectivity MRI (rs- fcMRI), a specific neuroimaging technique, has emerged as a reliable research tool to objectively assess, understand, and predict clinical pain in syndromes such as fibromyalgia. Preliminary results from our CDA-1 investigation reveal a trend towards improved pain and function with a FDA-approved, non-pharmacologic therapy - auricular percutaneous electrical neural field stimulation (PENFS) - over standard therapy control, correlating to altered network connectivity on rs-fcMRI. PENFS-related improvements continued through 12 weeks following the completion of treatment and correlated to changes in cross-network connectivity, which differed between groups. OBJECTIVE: The proposed CDA-2, a randomized, sham-controlled trial of auricular PENFS, evaluates 1) the clinical utility of PENFS for fibromyalgia as compared to sham placebo control, 2) short- and long-term PENFS-related neural changes visualized on rs-fcMRI and 3) the ability of rs-fcMRI to predict PENFS treatment response. HYPOTHESIS: True PENFS results in non-placebo-related short- and long-term pain and functional improvements that can be correlated with altered connectivity and predicted by baseline rs-fcMRI. METHODS: Fifty total subjects (male and female veterans, age 20-60 years old) will be randomized to either sham (n=25) or true (n=25) auricular PENFS. Neuroimaging data, self-reported pain, and function will be assessed at baseline and at 1 and 12 weeks post-treatment to evaluate neural correlates of PENFS-related treatment. Subjects who meet study criteria will receive baseline assessments including rs- fcMRI, Defense and Veterans Pain Rating Scale (DVPRS) measures, PROMIS measures, arm curl, 30-s chair stand, handgrip strength tests, and baseline analgesic consumption. Subjects will be block-randomized, stratified based on gender, to either true or sham PENFS (series of 4, weekly) treatments and assessed for rs- fcMRI and functional changes at 1 and 12 weeks post-treatment. This study addresses the critical need to identify and understand neural correlates of pain and non-opioid pain management. CAREER DEVELOPMENT PLAN: Mentors and collaborators provide direct guidance related to neuroanatomy, neuroimaging acquisition and analysis, and clinical trials research and data analysis. Didactic coursework and conference attendance provide clinical trials research (completion of Masters of Science in Clinical Research curriculum) and advanced neuroimaging skills. Experience and skills gained from the CDA-2 training will be used to apply for future proposals such as a VA Merit to gain academic independence. IMMEDIATE GOALS: 1) to build upon a foundation of knowledge gained from my CDA-1 in using neuroimaging as a biomarker to examine the neural correlates of pain and analgesic outcomes, and 2) to leverage the skills learned through my MSCR and CDA-1 training to conduct a randomized, double-blind, placebo-controlled clinical trial. LONG- TERM GOAL: to become a successful investigator and international leader in pain research, focusing on 1) understanding neural correlates of pain, 2) developing more reliable and objective biomarkers for chronic pain assessment, and 3) assessing non-pharmacologic and opioid-sparing therapies for pain.

候选人：Woodbury博士是一名8/8 va付费雇佣双板认证麻醉师和疼痛师

项目成果

Evolving Understanding of the Classification of Fibromyalgia Following Surgery.

对手术后纤维肌痛分类的理解不断发展。

• DOI: 10.1093/pm/pnab158
• 发表时间: 2022
• 期刊: Pain medicine (Malden, Mass.)
• 作者: Meka,Arjun;Ji,Dabin;Woodbury,Anna
• 通讯作者: Woodbury,Anna

Waste not, want not: upcycling research data from chronic pain trials.

• DOI: 10.1097/pr9.0000000000001070
• 发表时间: 2023-05
• 期刊: Pain reports
• 影响因子: 4.8