Subgrouping Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Linking the Powerhouses of Cells to the Autonomic Nervous System
Key facts
- Who runs it
- Vrije Universiteit Brussel
- Where
- Belgium1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 105 people, planned
- Started
- 21 Oct 2024
- Expected to end
- 1 May 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Exercise test
- Active standing test
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Between the ages of 18 and 70
- Speak Dutch
- ME/CFS syndrome (confirmed by a medical diagnosis)
- Healthy individuals wishing to participate must be currently pain-free and healthy (i.e., participants must not be ill during the period of study participation)
Who cannot take part
- Persons taking medications that affect the autonomic nervous system such as beta blockers
- Persons with a chronic illness such as a rheumatological, endocrine, neurological or psychiatric condition
- Persons with a history of cancer or heart disease
- Pregnant women or women who were pregnant in the past year
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this study is to investigate whether mitochondrial dysfunction is present in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) by subgrouping them into autonomic phenotypes. The main questions it aims to answer are:
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* When patients with ME/CFS are exposed to situations stressing the mitochondria and autonomic nervous system, is the response of their mitochondria and autonomic nervous system dependent on to which autonomic profile the patients belong? * Is the presence of mitochondrial dysfunction dependent on to which autonomic profile a patient with ME/CFS belongs? Researchers will compare healthy control subjects because very little is known about the link between mitochondria and the autonomic nervous system. It is therefore important that this is also investigated in healthy control subjects to gain a better understanding of which biological changes are normal and which changes may be involved in the symptoms of patients with ME/CFS.
Participants will:
* Undergo an exercise test (to stress the mitochondria) and an orthostatic test (to stress the autonomic nervous system) * Fill in questionnaires * Undergo blood collection
The 2 groups in the trial
- Healthy controlsTreatment being tested
Study participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing us to determine whether autonomic phenotype and mitochondrial function can predict PEM severity.
Treatment: Exercise test and Active standing test
- ME/CFS patientsTreatment being tested
Study participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing us to determine whether autonomic phenotype and mitochondrial function can predict PEM severity.
Treatment: Exercise test and Active standing test
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mitochondrial Dysfunction in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Are Autonomic Phenotypes Necessary to Clear Conflicting Results?
- Record updated
- 9 November 2026