Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Cardiopulmonary Exercise Test (CPET) - RER
研究概览
简要总结
Background:
Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes.
Objective:
To learn more about PI-ME/CFS.
Eligibility:
Adults ages 18-60 years who have finished at least 7th grade education and either:
have ME/CFS that started after an infection
OR had Lyme disease, were treated, and returned to normal health
OR are healthy volunteers
Design:
Participants will initially have a 2-5 day inpatient visit at the National Institutes of Health Clinical Center in Bethesda. During the visit, participants will have:
Medical history
Physical exam
Intravenous (IV) line. A thin plastic tube is inserted into a vein.
Blood and urine collected
Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.
Grip strength tested
Saliva, cheek swab, and stool collected
Tilt table test with measures of body functions such as sweating and breathing, blood pressure, and heart rate and blood and urine sample collection
Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.
Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
Heart monitoring
Sleep study for participants with PI ME/CFS
Questions about the participant s life and how they are feeling
Questions from a neuropsychologist
Questions from an occupational therapist for participants with PI ME/CFS
Questinos from a nutritionist
After the initial visit participants will return home. Participants evaluated for PI-ME/CFS during the first visit will have their information reviewed by an adjudication panel of experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate in the second study visit.
Eligible participants will be invited back for a second study visit. If a participant was taking certain medications during the first visit, they may be asked to taper off of them prior to the second visit and report any problems. They will also receive an activity monitor, fatigue diary, and nutrition log to use for at least one week prior to their second visit.
Participants who are eligible will return for a 5-10 day inpatient hospital visit at the National Institutes of Health Clinical Center. During the visit, participants will undergo measurements before and up to 96 hours after performing a stationary bike exercise test. The purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests will be performed before and after exercise testing. These include:
Sleeping in a room that measures how the body uses energy with EEG monitoring
Eating a controlled diet
Performing vigorous exercise for 10-15 minutes
Questions about how participants are feeling
Questions about what participants usually eat
Samples of saliva, blood, urine and stool
Wearing an activity monitor
Having an Xray that measures body composition
Thinking and memory tests
Heart monitoring
Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.
Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.
Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
详细描述
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 206 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 a full recovery from COVID-19 infection, 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. Up to an additional 10 healthy volunteers and 10 ME/CFS patients may be enrolled to refine the protocol's electrophysiological and neuroimaging techniques.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cardiopulmonary Exercise Test (CPET) - RER
时间窗: At time of AT during CPET
The Respiratory Exchange Ratio (VCO2/VO2) was determined during a cardiopulmonary exercise test (CPET). VCO2/VO2 is calculated by measuring the volume of carbon dioxide and oxygen the participant breathes during CPET. When the volume of carbon dioxide exceeds that of oxygen, it reflects a change from aerobic metabolism to anaerobic metabolism. When a participant has a Respiratory Exchange Ratio (RER) during CPET that is equal or greater than 1.1 it is considered a sufficient exercise effort. Results compared Healthy Volunteer Participants to ME/CFS Participants.
Cardiopulmonary Exercise Test (CPET) - ATVO2rel
时间窗: At time of AT during CPET
The Relative Volume of Oxygen at the Anaerobic Threshold (ATVO2rel) was determined during a cardiopulmonary exercise test (CPET). ATVO2rel represents the volume of oxygen being consumed when a participant reaches AT, adjusted for their weight during the CPET. Results compared Healthy Volunteer Participants to ME/CFS Participants.
次要结局
未报告次要终点
