Scientists probe the mysterious crash that defines ME/CFS
NCT ID NCT07715838
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study investigates post-exertional malaise (PEM), the hallmark symptom of ME/CFS, where even minor activity triggers severe symptom worsening. Researchers will compare 50 ME/CFS patients with 50 healthy volunteers matched by age, sex, and activity level. Participants undergo physical and mental tasks while their heart rate, blood pressure, brain activity, muscle function, and blood markers are measured before, during, and after exertion. The goal is to uncover the biological roots of PEM and pave the way for objective diagnostic tests.
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 this study succeeds, it could reveal the biological mechanisms behind post-exertional malaise in ME/CFS, pointing toward objective diagnostic criteria and potential treatment targets.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly help patients. The findings may be complex and not lead to immediate clinical changes.
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.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with diagnosed ME/CFS according to the international consensus criteria or the canadian consensus criteria and 50 controls matched on group level for age, sex, and activity.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Willing and be able to complete all study procedures * Able to provide informed consent Additional inclusion criteria for ME/CFS patients * ME/CFS patients have to meet the criteria of the ICC OR CCC. * A self-reported illness narrative of the development of persistent fatigue and post-exertional malaise according to the DSQ-2. The persistent fatigue may have an acute onset or become progressively worse over 6 months. Exclusion Criteria: * Use of immune-modulating drugs in the past 3 months. * A serious medical condition that may explain symptoms similar to ME/CFS, such as cancer, coronary artery disease, uncontrolled diabetes, chronic infection (hepatitis B and C, tuberculosis, HIV), inflammatory diseases, autoimmune diseases (e.g. such as rheumatoid arthritis, lupus or polymyositis), severe COPD or other severe persistent respiratory disease, severe anemia, renal failure, Addison's or Cushing's disease or severe neurological disease (such as Parkinson's disease). * History of head injury with loss of consciousness or amnesia lasting greater than a few seconds within last 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. * Suspected, probable, or confirmed Lyme disease * Current or substance use disorder within last 5 years * A mood disorder or other psychiatric diagnosis prior to a diagnosis of ME/CFS. * Pregnant, actively seeking to become or breastfeeding in the past 12 months. * BMI \>35. * having cognitive or communication problems which reduces the capacity to understand instructions. * planned a change in medication during the testing period. * Use of medication that affects the blood pressure (e.g. Beta-blockers, fludrocortisone, vasoconstrictors). * 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. * Claustrophobia * Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the visits. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications. * Use of B12 high dosage injections * Being colorblind Additional exclusion criteria for control subjects: * performing high intensity or moderate intensity activities more than 30 minutes per week * substantial fatigue as determined using MFIS fatigue questionnaire \>30
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UMC Groningen
RECRUITINGGroningen, 9713VB, Netherlands
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