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. ]

Fatigue will be explored using tasks designed to create muscular and cognitive fatigue. PEM will be explored using an exercise stress and measuring the symptomatic and biological alterations that occur before and afterwards.


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