Brain mechanisms for clinical placebo in chronic pain

慢性疼痛临床安慰剂的脑机制

基本信息

批准号：
9308812
负责人：
Apkar Vania Apkarian
金额：
$ 55.29万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9308812
关键词：
Absence of pain sensation Acute Pain Address Adverse effects Algorithms Analgesics Anatomy Automobile Driving Behavioral Biological Markers Blinded Brain Brain imaging Brain scan Caring Cellular Phone Clinic Clinical Clinical Management Clinical Trials Coupled Data Degenerative polyarthritis Development Discrimination Double-Blind Method Eligibility Determination Healthcare Human Imaging Techniques Individual Instruction Internist Knowledge Link Measurement Measures Methods Monitor Neurobiology Neurosciences Neurotransmitters Pain Pain intensity Pain management Pain quality Participant Patient Self-Report Patients Pattern Personality Pharmaceutical Preparations Physicians Placebo Effect Placebos Population Prevalence Procedures Property Quality of life Randomized Reproducibility Research Surveys Techniques Technology Testing Therapeutic Time Translating active method base chronic back pain chronic pain clinically relevant clinically significant design duloxetine expectation experimental study gabapentin instrument neuroimaging neuroimaging marker neuromechanism neurotransmitter release novel novel strategies outcome prediction predicting response prediction algorithm predictive tools public health relevance responders and non-responders response rheumatologist tool treatment response

项目摘要

DESCRIPTION (provided by applicant): This application is designed to examine brain properties for placebo responses in chronic back pain patients. We have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) and osteoarthritis patients can be subdivided into placebo responders and non- responders and these differences are PREDICTABLE a priori by brain activity. The results imply that CBP placebo response may have clinical utility and that its properties can be studied by human brain imaging techniques. We address these issues in three specific aims, where CBP placebo response properties are studied in a double blind clinical trial (RCT) setting. In Aim 1, we will examine the reproducibility and predictability of the propensity to placebo response in CBP patients. Brain anatomy and function are assessed prior to the start of the RCTs and at different time points during the trial. Additionally, pain and quality of life profilesare collected throughout the trial, using smart phone technology monitoring to acquire these parameters in a naturalistic setting. Brain biomarker outcomes and predictions are contrasted between CBP placebo responders and non- responders, and compared to no treatment. Washout periods are used to test for reversibility of placebo responses. In Aim 2, we study the interaction between placebo and medication treatment, and validate the predictability of placebo propensity in CBP. In Aim 3, we develop a self-report measure to predict placebo propensity based on correlations with neuro-imaging biomarkers. Overall, these studies are designed to critically assess the neurobiology of placebo analgesia for chronic pain within the setting of clinical trials, and creating a readily available clinically useful instrument to identify placebo responders. If successful, the completion of the outlined studies has the potential to dramatically alter health care in chronic pain.

描述（由申请人提供）：该应用程序旨在检查慢性背痛患者的安慰剂反应的大脑特性。我们的初步数据表明，在关于治疗的中立指导的盲法临床试验研究中，慢性背痛（CBP）和骨关节炎患者可以细分为安慰剂反应者和无反应者，并且这些差异是可以通过大脑活动先验预测的。结果表明，CBP 安慰剂反应可能具有临床实用性，并且其特性可以通过人脑成像技术进行研究。我们通过三个具体目标解决这些问题，其中在双盲临床试验 (RCT) 环境中研究 CBP 安慰剂反应特性。在目标 1 中，我们将检查 CBP 患者安慰剂反应倾向的再现性和可预测性。在随机对照试验开始之前以及试验期间的不同时间点对大脑解剖结构和功能进行评估。此外，在整个试验过程中收集疼痛和生活质量概况，使用智能手机技术监控在自然环境中获取这些参数。将 CBP 安慰剂应答者和无应答者之间的脑生物标志物结果和预测进行对比，并与未治疗者进行比较。清除期用于测试安慰剂反应的可逆性。在目标 2 中，我们研究安慰剂和药物治疗之间的相互作用，并验证 CBP 中安慰剂倾向的可预测性。在目标 3 中，我们开发了一种自我报告测量方法，根据与神经影像生物标志物的相关性来预测安慰剂倾向。总体而言，这些研究旨在在临床试验的背景下严格评估安慰剂镇痛治疗慢性疼痛的神经生物学，并创建一种现成的临床有用工具来识别安慰剂反应者。如果成功，完成概述的研究有可能显着改变慢性疼痛的医疗保健。