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。第二个目标是探索疲劳和劳后不适(PEM)的病理生理学。 作为该方案的一部分，研究人群将最多录取186人。多达150名年龄在18-60岁之间的人将被分成3个研究组：50名在感染后开始疲劳的ME/CFS患者，50名有莱姆病暴露和治疗记录的非疲劳性参与者，以及50名健康志愿者。这项研究的目标是完成每组20名登记参与者的所有研究程序。另外，多达36名报告社区诊断为ME/CFS的人将被纳入重点小组，讨论劳后不适的经历。 设计这是一项关于PI-ME/CFS的单中心、探索性、横断面研究。参与者将进行表型检查，包括在NIH临床中心住院2-5天。ME/CFS参与者的病例状态将在表型访问后通过利用专家医师委员会和公布的指南进行病例裁决过程来确定。符合纳入标准的被判定参与者将被邀请回来参加运动应激访问，其中包括为期5-10天的住院治疗。详细的主观和客观测量和生物标本将在这次访问期间可能导致劳累后不适的高峰运动测试之前和之后连续收集96小时。所有三个研究组的所有程序都将完成，以便进行最佳的组间比较。 结果衡量标准 1.血液和脑脊液中免疫系统和炎症信号的特征 2.肠道、血液和脑脊液中微生物菌群类型的特征 3.使用功能磁共振成像和经颅磁刺激来表征身体和认知疲劳 4.最大强度运动对神经认知的影响 5.最大强度运动对大脑功能和连接性的影响 6.最大强度运动对免疫功能紊乱和炎症标志物的影响 7.最大强度运动对代谢功能的影响 8.最大强度运动对自主神经功能的影响 9.最大强度运动对血液和脑脊液基因表达谱的影响