Clinical Trial: Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Brief Summary:
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
Detailed Summary:
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 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.
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 a
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Current Primary Outcome: To explore the clinical and biological phenotypes of post-infectious chronic fatigue syndrome (PI-ME/CFS) [ Time Frame: Week 1: Single time point measurement ]
Original Primary Outcome:
- Effect of exercise on neurocognition, brain connectivity, markers of immune dysfunction and inflammation, metabolic function, autonomic function, and gene expression profiles in blood and CSF [ Time Frame: End of partcipation ]
- Characterization of the pattern of microbiome in gut, blood and CSF, and 2) sleep dysfunction [ Time Frame: End of participation ]
Current Secondary Outcome: To explore the pathophysiologies of fatigue and post-exertional malaise (PEM). [ Time Frame: Week 2: Pre-exercise stress, 4 hours, 24 hours, and 48 hours. Additional measurement for PI-ME/CFS at 72 and 96 hrs. ]
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: January 29, 2016
Date Started: January 20, 2016
Date Completion: September 15, 2018
Last Updated: April 21, 2017
Last Verified: March 29, 2017