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。 次要目标是探索疲劳和劳力后不适 (PEM) 的病理生理学。 研究人群：作为本方案的一部分，最多将招募 346 人。最多 150 名 18-60 岁的人将被分成 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史的非疲劳参与者，以及 50 名健康志愿者。该研究的目标是完成每组 20 名注册参与者的所有研究程序。另有 176 名报告社区诊断为 ME/CFS 的人将被纳入焦点小组，讨论劳累后不适的经历。最多可招募 10 名健康志愿者和 10 名 ME/CFS 患者来完善方案的电生理学和神经影像技术。 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，其中包括在 NIH 临床中心住院 2-5 天。 ME/CFS 参与者的病例状态将在表型分析访问后通过病例裁决程序利用专家医师委员会和已发布的指南来确定。符合纳入标准的评审参与者将被邀请回来参加运动压力访问，其中包括为期 5-10 天的住院治疗。将在峰值运动测试之前和之后 96 小时内连续收集详细的主观和客观测量结果以及生物样本，该测试能够在本次访问期间引起运动后不适。所有程序将在所有三个研究组中完成，以实现最佳的组间比较。 结果测量：本协议的主要目的是对收集的样本进行探索性分析，以生成有关 ME/CFS 的新假设。要执行的分析类型范围广泛。计划的重点领域包括： 1. 在基线和最大运动强度后收集的样本中免疫系统和炎症信号的表征。 2. 基线时和最大运动强度后收集样本中微生物组模式的表征。 3. 在基线和最大运动强度后收集的样本中的生物能量学、自主神经和代谢功能的表征。 4. 使用功能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的神经认知特征。 6. 基线和最大运动强度后大脑功能和连接性的表征。 7. 基线和最大运动强度后自主神经功能的表征。 8. 基线时和最大运动强度后收集样本中基因表达谱的表征。