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NCT02669212 · ClinicalTrials.gov registry record · NA
Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
A NA study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT02669212: Completed NA study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02669212 is a NA study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02669212, a NA study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- BEHAVIORAL Cardiopulmonary Exercise Test (CPET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2016-10-10 |
| Est. Completion | 2022-01-11 |
| Phase | NA |
What the finished NCT02669212 record still lists
NCT02669212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cardiopulmonary Exercise Test (CPET) is the first listed.
NCT02669212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02669212 about?
NCT02669212 is a clinical study titled "Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health". 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 mo...
What is the current status of trial NCT02669212?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2016-10-10. Estimated completion is 2022-01-11.
What interventions are being tested in trial NCT02669212?
The interventions under investigation include: Cardiopulmonary Exercise Test (CPET) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02669212?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02669212's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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