Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
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|ClinicalTrials.gov Identifier: NCT02669212|
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : October 7, 2019
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.
To learn more about PI-ME/CFS.
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
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:
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.
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
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.
|Condition or disease|
|Chronic Fatigue Syndrome|
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).
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 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. Up to an additional 10 healthy volunteers and 10 ME/CFS patients may be enrolled to refine the protocol's electrophysiological and neuroimaging techniques.
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.
- Characterization of the immune system and inflammatory signaling in blood and cerebrospinal fluid (CSF)
- Characterization of the pattern of microbiome in gut, blood and CSF
- Characterization of physical and cognitive fatigue using functional magnetic resonance imaging and transcranial magnetic stimulation
- Effect of maximal exertion on neurocognition
- Effect of maximal exertion on brain function and connectivity
- Effect of maximal exertion on markers of immune dysfunction and inflammation
- Effect of maximal exertion on metabolic function
- Effect of maximal exertion on autonomic function
- Effect of maximal exertion on gene expression profiles in blood and CSF
|Study Type :||Observational|
|Estimated Enrollment :||346 participants|
|Official Title:||Myalgic Encephalomyelitis/Chronic Fatigue Syndrome|
|Actual Study Start Date :||October 10, 2016|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||June 30, 2024|
Focus Group participants
Documented Lyme infection asymptomatic participants
Post-infectious Myalgic Encephalomyelitis /Chronic Fatigue Syndrome participants
Technical Development sub-study
- Characterization of the immune system and inflammatory signaling inblood and CSF [ Time Frame: End of Study ]See measures
- Characterization of the pattern of microbiome in gut, blood and CSF [ Time Frame: End of Study ]See measures
- Characterization of physical and cognitive fatigue using functional magnetic resonance imaging and transcranial magnetic stimulation [ Time Frame: End of Study ]See measures
- Effect of maximal exertion on neurocognition [ Time Frame: End of Study ]See measures
- Effect of maximal exertion on brain function and connectivity [ Time Frame: End of Study ]See measures
- Effect of maximal exertion on markers of immune dysfunction and inflammation [ Time Frame: End of Study ]See measures
- Effect of maximal exertion on metabolic function [ Time Frame: End of Study ]See measures
- Effect of maximal exertion on autonomic function [ Time Frame: End of Study ]See measures
- Effect of maximal exertion on gene expression profiles in blood and CSF [ Time Frame: End of Study ]See measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669212
|Contact: Angelique Gavin||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Avindra Nath, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|