Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

肌痛性脑脊髓炎/慢性疲劳综合症

基本信息

批准号：
9362239
负责人：
Avindra Nath
金额：
$ 12.72万
依托单位：
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9362239
关键词：
Admission activity Back Biological Blood Brain Cerebrospinal Fluid Chronic Fatigue Syndrome Clinical Cognitive Communities Cross-Sectional Studies Diagnosis Enrollment Exercise Exercise stress test Exertion Fatigue Focus Groups Functional Magnetic Resonance Imaging Functional disorder Gene Expression Guidelines Hour Immune System Diseases Immune system Infection Inflammation Inflammatory Inpatients Lyme Disease Malaise Measurement Measures Metabolic Molecular Profiling Muscle Neurocognition Outcome Measure Participant Patients Pattern Persons Phenotype Physicians Procedures Process Protocols documentation Publishing Recording of previous events Reporting Signal Transduction Specimen Stress Transcranial magnetic stimulation United States National Institutes of Health Visit adjudicate adjudication aged comparison group design experience healthy volunteer inclusion criteria meetings microbiome study population

项目摘要

Objective The primary objective is to explore the clinical and biological phenotypes of post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS). The secondary objective is to explore the pathophysiology of fatigue and post-exertional malaise (PEM). Study population Up to 186 persons will be enrolled as part of this protocol. Up to 150 persons aged 18-60 will be part of 3 study groups: 50 ME/CFS patients whose fatigue began after an infection, 50 non-fatigued participants with a documented history of Lyme disease exposure and treatment, and 50 healthy volunteers. The study has a target of completing all study procedures on 20 enrolled participants in each group. Up to an additional 36 persons reporting a community diagnosis of ME/CFS will be enrolled into focus groups to discuss the experience of post-exertional malaise. Design This is a single-center, exploratory, cross-sectional study of PI-ME/CFS. Participants will have a phenotyping visit, which will encompass a 2-5 day long inpatient admission at the NIH Clinical Center. Case status for ME/CFS participants will be determined after the phenotyping visit by a case adjudication process utilizing an expert physician committee and published guidelines. Adjudicated participants meeting inclusion criteria will be invited back to participate in an exercise stress visit, which will encompass a 5-10 day long inpatient admission. Detailed subjective and objective measurements and biological specimens will be serially collected before and up to 96 hours after a peak exercise test capable of inducing post-exertional malaise during this visit. All procedures will be completed on all three study groups to allow for optimal inter-group comparisons. Outcome measures 1. Characterization of the immune system and inflammatory signaling in blood and cerebrospinal fluid (CSF) 2. Characterization of the pattern of microbiome in gut, blood and CSF 3. Characterization of physical and cognitive fatigue using functional magnetic resonance imaging and transcranial magnetic stimulation 4. Effect of maximal exertion on neurocognition 5. Effect of maximal exertion on brain function and connectivity 6. Effect of maximal exertion on markers of immune dysfunction and inflammation 7. Effect of maximal exertion on metabolic function 8. Effect of maximal exertion on autonomic function 9. Effect of maximal exertion on gene expression profiles in blood and CSF

目的主要目标是探索感染后肌动脑膜炎/慢性疲劳综合征（PI-ME/CFS）的临床和生物表型。次要目标是探索疲劳和屈服后不适（PEM）的病理生理学。作为该协议的一部分，将招募多达186人的研究人群。最多150名18-60岁的人将是3个研究组的一部分：50例ME/CFS患者，他们的疲劳在感染后开始，有50名非受理参与者，有记录的莱姆病病史和治疗史，还有50名健康志愿者。该研究的目标是完成所有研究中的20名参与者的所有研究程序。最多有36人报告了对ME/CFS的社区诊断的人，将被纳入焦点小组，以讨论后期不适的经验。设计这是PI-ME/CFS的单中心，探索性的横断面研究。参与者将进行表型访问，该访问将包括在NIH临床中心进行2-5天的住院入院。我/CFS参与者的案件状态将在使用专家医师委员会的案件裁决程序进行表型访问后确定，并发布了指南。遵守纳入标准的裁决参与者将被邀请参加运动压力访问，这将包括5-10天长的住院入学。详细的主观和客观测量以及生物标本将在峰值运动测试后最多串行96小时，可在此访问期间诱发后期不适。所有程序将在所有三个研究组上完成，以允许进行最佳的组间比较。结果措施 1。血液和脑脊液（CSF）中免疫系统的表征和炎症信号传导 2。肠道，血液和CSF中微生物组模式的表征 3。使用功能磁共振成像和经颅磁刺激的物理和认知疲劳表征 4。最大运动对神经认知的影响 5。最大劳累对脑功能和连通性的影响 6。最大劳累对免疫功能障碍和炎症标记的影响 7。最大劳累对代谢功能的影响 8。最大劳累对自主功能的影响 9。最大劳累对血液和CSF基因表达谱的影响