Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) as defined by the Institute of Medicine is "an acquired, chronic multi-systemic disease characterized by significant relapse after physical, cognitive, or emotional exertion of any sort. The disease includes immune, neurological and cognitive impairment, sleep abnormalities, and autonomic dysfunction, resulting in significant functional impairment accompanied by a pathological level of fatigue. The cause of the disease remains unknown, although in many cases symptoms may have been triggered by an infection or other prodromal event".  There are no approved diagnostics tests or treatments.
The objective of this research study is to begin to understand the clinical and biological characteristics of ME/CFS. Participants in the study will not receive treatment. However, insights obtained may lead to the development of new and effective treatments as well as diagnostic tests for this condition.
In this first phase of research, we will focus on patients who developed symptoms of ME/CFS after an infection, which we refer to as 'post-infectious ME/CFS' (PI-ME/CFS). Information obtained from those with ME/CFS will be compared to those in 2 control groups: 1) people with documented treated Lyme disease and 2) healthy volunteers. The study will be conducted at the NIH Clinical Center in Bethesda, Maryland, to capitalize on the multi-disciplinary state-of-the art research and diagnostic facilities uniquely available in this location. We anticipate that information obtained in this first study will inform future studies of ME/CFS, both at the National Institutes of Health (NIH) and at academic centers world-wide, that study the entire range of ME/CFS clinical presentations.
Initial screening of potential participants is expected to begin in summer 2016.
We plan to study three different groups of people. All participants must be 18-60 years old and have finished at least 7th grade education. Volunteers must fit into one of the four groups below:
- Have ME/CFS that started after an episode of infection and severe symptoms based on the study evaluation for more than 6 months and less than 5 years;
- Have a history of Lyme disease that was treated resulting in resolution of symptoms; or
- Be a healthy volunteer.
Participation in this study includes an initial phone screening, an in-person screening visit, and a one-week inpatient stay at the NIH Clinical Center. A brief description of the procedures that will be performed is provided below.
Screening procedures: Interested individuals will initially complete a telephone screening with the study staff, to determine if they might be eligible and for which participant group.
Those who may be eligible and are interested in participating will be asked to visit the NIH Clinical Center outpatient clinic for screening procedures, which include:
- An explanation of the study and signing of the research study consent form
- Medical history
- Physical exam
- Blood and urine collection
- Questions about the participant’s life and their quality of life
- Questions about the participant’s mental health
Eligible participants will also have the following procedures during the outpatient evaluation:
- Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through an intravenous (IV) line that is placed in their arm. (A thin plastic tube inserted into a vein).
- Hand grip strength test
- Saliva test for virus testing
- Tests of body functions such as sweating and breathing, blood pressure while standing upright, sitting and lying, and heart rate.
- 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 participants' vein.
- An explanation on how to wear an activity monitor and complete a fatigue diary. Participants will use these tools to record their activity and fatigue symptoms for at least one week once they are back at home.
- Review of medications. Participants may be asked to taper off certain medicines that affect the brain and nerves.
The screening visit will take two to three days.
After screening, participants will return home. They will taper off medications and report any problems to the study team. They will also use the activity monitor and fatigue diary that they received at the screening visit for at least one week. Participants will return for a 1-week inpatient hospital visit within six months of the first visit. During the inpatient visit, participants will perform a stationary bike exercise test twice. The purpose of the exercise test is to make participants tired and to try to evoke symptoms, such as 'post-exertional malaise'. Tests will be performed before and after exercise testing.
The tests include:
- Questions about how participants are feeling
- Samples of saliva, stool, and a cheek swab to test stress hormones and the types of bacteria living in the mouth and gut.
- Thinking and memory tests
- Overnight heart monitoring
- Transcranial magnetic stimulation. A brief magnetic pulse from a magnet held over the scalp can affect brain activity and will be used to examine what brain excitability changes occur with muscle fatigue.
- Imaging studies such as an X-ray and magnetic resonance imaging (MRI). During an MRI participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI to examine what changes in brain activity occur with different types of fatigue.
- Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
1: CFSAC recommendations (http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf)