Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

肌痛性脑脊髓炎/慢性疲劳综合症

• 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
• 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

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

目的探讨感染后肌痛性脑脊髓炎/慢性疲劳综合征（PI-ME/CFS）的临床和生物学表型。 次要目的是探索疲劳和运动后不适（PEM）的病理生理学。 研究人群作为本方案的一部分，最多将入组186人。多达150名年龄在18-60岁之间的人将参加3个研究组：50名ME/CFS患者，他们在感染后开始疲劳，50名非疲劳参与者，有莱姆病暴露和治疗记录，以及50名健康志愿者。本研究的目标是每组20例入组受试者完成所有研究程序。另外36名报告ME/CFS社区诊断的人将被纳入焦点小组，以讨论运动后不适的经历。 设计这是一项单中心、探索性、横断面研究的PI-ME/CFS。 参与者将进行表型分析访视，包括在NIH临床中心住院2-5天。ME/CFS受试者的病例状态将在表型访视后通过病例裁定过程确定，该过程使用专家医师委员会和已发表的指南。将邀请符合入选标准的裁定受试者参加运动应激访视，其中包括5-10天的住院治疗。在此次访视期间，将在能够诱导劳力后不适的峰值运动试验之前和之后96小时内连续采集详细的主观和客观测量值以及生物标本。将在所有三个研究组中完成所有程序，以便进行最佳组间比较。 观察指标 1. 血液和脑脊液（CSF）中免疫系统和炎症信号的表征 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表征身体和认知疲劳 4. 极量运动对神经认知功能的影响 5. 最大运动量对脑功能和连通性的影响 6. 最大运动量对免疫功能障碍和炎症标志物的影响 7. 极量运动对代谢功能的影响 8. 极量运动对植物神经功能的影响 9. 极量运动对血液和脑脊液中基因表达谱的影响