Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

肌痛性脑脊髓炎/慢性疲劳综合症

• 批准号: 10684595
• 负责人: Avindra Nath
• 金额: $ 109.51万
• 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/10684595
• 关键词: Admission activity; Area; Back; Bioenergetics; Biological; Brain; Chronic Fatigue Syndrome; Clinical; Cognitive; Communities; Cross-Sectional Studies; Diagnosis; Electrophysiology (science); Enrollment; Exercise; Exercise Test; Exertion; Fatigue; Focus Groups; Functional Magnetic Resonance Imaging; Functional disorder; Gene Expression; Generations; Guidelines; Hour; Immune system; Infection; Inflammatory; Inpatients; Lyme Disease; Malaise; Measurement; Measures; Metabolic; Muscle; Neurocognition; Outcome Measure; Participant; Patients; Pattern; Persons; Phenotype; Physicians; Procedures; Process; Protocols documentation; Publishing; Recording of previous events; Reporting; Sampling; Signal Transduction; Specimen; Stress; Techniques; Transcranial magnetic stimulation; United States National Institutes of Health; Visit; adjudicate; adjudication; aged; clinical center; comparison group; design; experience; healthy volunteer; inclusion criteria; meetings; microbiome; neuroimaging; 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 346 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 176 persons reporting a community diagnosis of ME/CFS will be enrolled into focus groups to discuss the experience of post-exertional malaise. Up to an additional 10 healthy volunteers and 10 ME/CFS patients may be enrolled to refine the protocols' electrophysiological and neuroimaging techniques. 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: The primary purpose of this protocol is to perform exploratory analysis of collected samples for the generation of new hypotheses regarding ME/CFS. The types of analyses to be performed will be wide ranging. Planned areas of focus include: 1. Characterization of the immune system and inflammatory signaling in collected samples at baseline and following maximal exercise exertion. 2. Characterization of the pattern of microbiome in collected samples at baseline and following maximal exercise exertion. 3. Characterization of bioenergetics, autonomic, and metabolic function in collected samples at baseline and following maximal exercise exertion. 4. Characterization of physical and cognitive fatigue using functional magnetic resonance imaging and transcranial magnetic stimulation at baseline and following maximal exercise exertion. 5. Characterization of neurocognition at baseline and following maximal exercise exertion. 6. Characterization of brain function and connectivity at baseline and following maximal exercise exertion. 7. Characterization of autonomic function at baseline and following maximal exercise exertion. 8. Characterization of gene expression profiles in collected samples at baseline and following maximal exercise exertion.

目的：主要目的是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346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。多达176人报告ME/CFS的社区诊断将被纳入焦点小组，以讨论运动后不适的经验。最多可招募10名健康志愿者和10名ME/CFS患者，以完善方案的电生理和神经成像技术。 设计：这是一项PI-ME/CFS的单中心、探索性、横断面研究。 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。 结果测量：本方案的主要目的是对采集的样本进行探索性分析，以生成关于ME/CFS的新假设。要进行的分析类型将是广泛的。计划的重点领域包括： 1. 在基线和最大运动消耗后收集的样品中的免疫系统和炎症信号的表征。 2. 在基线和最大运动强度后收集的样品中微生物组模式的表征。 3. 基线和最大运动强度后采集样本的生物能量学、自主神经和代谢功能表征。 4. 使用功能性磁共振成像和经颅磁刺激在基线和最大运动强度后表征身体和认知疲劳。 5. 基线和最大运动强度后神经认知的特征。 6. 基线和最大运动强度后的脑功能和连通性表征。 7. 基线和最大运动强度后自主神经功能的表征。 8. 在基线和最大运动强度后收集的样品中的基因表达谱的表征。