Scientists scan brains to unravel why effort hurts in chronic fatigue
NCT ID NCT06472622
First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 6 times
Summary
This study uses functional MRI to see how the brain processes unpleasant sensations like pain and physical effort in people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) compared to healthy volunteers. Researchers will apply mild heat and ask participants to squeeze a bar while scanning their brains. The goal is to identify which brain regions are linked to the feeling of unpleasantness, which may help explain symptoms of ME/CFS.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help explain why people with ME/CFS find pain and effort more unpleasant, potentially guiding future treatments.
- What could go wrong
- This is a very early, small study (47 people) focused on measuring brain activity, not testing a treatment. It may not lead to direct benefits for patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 47 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2025
- Expected to finish
-
Jun 2034
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Healthy Controls: In order to be eligible to participate in this study as a healthy control, an individual must meet all the following criteria: 1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18-50 (inclusive). 4. Good general health as evidenced by medical history and/or physical examination. ME/CFS Patients: In order to be eligible to participate in this study as an ME/CFS patient, an individual must meet all the following criteria: 1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18-50 (inclusive). 4. Has a diagnosis of ME/CFS, meeting at least one of three ME/CFS criteria: the 1994 Fukuda Criteria, the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or the Institute of Medicine Diagnostic Criteria. EXCLUSION CRITERIA: Healthy Controls: 1. Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder. 2. Any other current major medical disorder, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively affect the individual s ability to cooperate with study procedures. 3. Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc. 4. Use of opioid medications for more than two weeks within the last two years or any use in the last month. 5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week). 6. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire. 7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire. 8. Condition or injury affecting grip. 9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated. 10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, known pregnancy, or plans to become pregnant during the study. 11. Members of the NINDS BNU and their family members. 12. Non-English speakers will be excluded from the study as several study instruments do not have validated translations. ME/CFS Patients: 1. Any current major neurological or psychiatric disorder, other than ME/CFS, such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder. 2. Any other current major medical disorder, other than ME/CFS, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively affect the individual s ability to cooperate with study procedures. 3. Current use of psychomotor stimulants, antipsychotics, or benzodiazepines. 4. Use of opioid medications for more than two weeks within the last two years or any use in the last month. 5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week). 6. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire. 7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire. 8. Condition or injury affecting grip. 9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated. 10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, known pregnancy, or plans to become pregnant during the study. 11. Members of the NINDS BNU and their family members. 12. Non-English speakers will be excluded from the study as several study instruments do not have validated translations.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Fatigue syndrome, chronic are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ancient remedy meets modern prebiotic: a new hope for Shift-Worker fatigue?
- Could a laser beam ease the pain of Ehlers-Danlos syndrome?
- Personalized exercise trial for chronic fatigue ends early
- Testosterone shot may ease fatigue in young cancer survivors
- Light strokes, big relief? touch therapy eases cancer fatigue
- Can a simple exercise test tell ME/CFS apart from heart disease?