N/A N=52 Screening

Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health

Chronic Fatigue Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02669212 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Cardiopulmonary Exercise Test (CPET) - ATVO2rel — 16.0; 10.6 mL/kg/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cardiopulmonary Exercise Test (CPET) (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Cardiopulmonary Exercise Test (CPET) - ATVO2rel	16.0; 10.6	—
PRIMARY Cardiopulmonary Exercise Test (CPET) - RER	1.3011; 1.2415	—

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 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.

Eligibility Criteria

INCLUSION CRITERIA:
Inclusion criteria for all participants
Adult participants aged 18-60 years at the time of enrollment.
Self-reported completion of at least the 7th grade of school.
Ability to speak, read, and understand English.
Willing and able to complete all study procedures
Participant has a primary care physician at the time of enrollment.
Able to provide informed consent.
Additional inclusion criteria for participants with PI-ME/CFS for the phenotyping visit:
A self-reported illness narrative of the development of persistent fatigue and post-exertional malaise as the consequence of an acute infection. The persistent fatigue may have an acute onset or become progressively worse over 6 months.
Licensed Independent Practitioner documentation of ME/CFS onset:
Medical documentation of absence of symptoms within one year of ME/CFS onset. This may include medical records, letters, or information gathered from telephone calls with study personnel.
Documentation of a medical evaluation for symptoms of an acute infection or documentation of a medical evaluation of persistent symptoms within 2 months following an assumed infection.
Persistent fatigue and PEM onset less than 5 years prior to enrollment.
Additional inclusion criteria for participants with PI-ME/CFS for the exercise stress visit:
Be unanimously considered to be a case of PI-ME/CFS by the protocol s adjudication committee.
Meet the 1994 Fukuda Criteria or the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome or the Institute of Medicine Diagnostic Criteria..
Have moderate to severe clinical symptom severity:
Severe fatigue as determined using the Multidimensional Fatigue Inventory (MFI): score of greater than or equal to 13 on the general fatigue subscale or greater than or equal to 10 on the reduced activity subscale.
Functional impairment as determined using the Short-Form 36 (SF-36): score of less than or equal to 70 physical function subscale, or less than or equal to 50 on role physical subscale, or less than or equal to 75 on social function subscale
Additional inclusion criteria for healthy volunteer group:

None

Additional inclusion criteria for COVID-19 Healthy Volunteers: documented prior COVID19 infection as evidenced by:
A history of clinical manifestations compatible with COVID-19
Laboratory evidence of Covid-19 infection:
Detectionof SARS-CoV-2RNA or antigen in nasopharyngeal swab, sputum, other sample source with Emergency Use Authorization/approval from the FDA; OR
A positive antibody test using an assay that has received Emergency Use Authorization/approval from the FDA
Has been recovered from the COVID-19 infection for at least six months and no more than five years.

EXCLUSION CRITERIA

Exclusion criteria for all participants:
Current or past psychotic disorder including depression with psychosis, bipolar disorder, and schizophrenia
Current DSM-5-defined major depression disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen
Current or prior substance use disorder as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5).
Current suicidal ideation
History of head injury with loss of consciousness or amnesia lasting greater than a few seconds within lasta five years or lasting greater than 5 minutes at any point during their lifetime. Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.

Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.

Women who are pregnant, actively seeking to become pregnant, or have been pregnant in the year prior to study enrollment.
Current or previous malignancy. Certain dermatologic malignancies (e.g. basal cell carcin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02669212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.