Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health

NCT02669212 | Completed Results

• 2 other identifiers: 16005816-N-0058
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Fatigue Syndrome

Keywords

Chronic Fatigue Syndrome; Lyme Disease; Healthy Volunteers; Movement Disorder

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary Exercise Test (CPET) - ATVO2rel

  The Relative Volume of Oxygen at the Anaerobic Threshold (ATVO2rel) was determined during a cardiopulmonary exercise test (CPET). ATVO2rel represents the volume of oxygen being consumed when a participant reaches AT, adjusted for their weight during the CPET. Results compared Healthy Volunteer Participants to ME/CFS Participants.

  At time of AT during CPET

• Cardiopulmonary Exercise Test (CPET) - RER

  The Respiratory Exchange Ratio (VCO2/VO2) was determined during a cardiopulmonary exercise test (CPET). VCO2/VO2 is calculated by measuring the volume of carbon dioxide and oxygen the participant breathes during CPET. When the volume of carbon dioxide exceeds that of oxygen, it reflects a change from aerobic metabolism to anaerobic metabolism. When a participant has a Respiratory Exchange Ratio (RER) during CPET that is equal or greater than 1.1 it is considered a sufficient exercise effort. Results compared Healthy Volunteer Participants to ME/CFS Participants.

  At time of AT during CPET

Other Outcomes (11)

• Characterization of Total Body Energy Use (Bioenergetics/Metabolic)

  12 hours

• Characterization of the Immune System and Inflammation - WBC

  Baseline

• Characterization of the Immune System and Inflammation - ESR

  Baseline

Study Arms (2)

Healthy Volunteer Participants

OTHER

Healthy volunteer participants

Behavioral: Cardiopulmonary Exercise Test (CPET)

ME/CFS Participants

OTHER

Participants with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Behavioral: Cardiopulmonary Exercise Test (CPET)

Interventions

Cardiopulmonary Exercise Test (CPET) BEHAVIORAL

All participants will undergo an exercise stress test

Healthy Volunteer Participants; ME/CFS Participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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 carcinoma) will be allowed. A history of malignancy that have fully resolved with surgical resection only (i.e. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.
• Current or previous long term immune suppressive or immunomodulatory therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment
• Any medical condition (eg, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, poorly controlled asthma) that would make the study procedures risky for the participant (e.g. exercise-induced angina and asthma) or that may confound the study results (e.g. untreated obstructive sleep apnea, severe osteoarthritis).
• Participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
• Inability to perform the bicycling exercise task.
• Clinically significant claustrophobia
• Not willing to allow for research samples to be shared with other researchers.
• Employees or staff at NIH that are directly supervised by the primary investigator or associate investigators.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Lyme Disease; Movement Disorders

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Results Point of Contact

• Title: Dr. Brian Walitt
• Organization: National Institutes of Health

brian.walitt@nih.gov

202-549-7669

Study Officials

• Avindra Nath, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 1, 2016
• Study Start: October 10, 2016
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2022-06-10

Locations

US (1)