Myalgic encephalomyelitis, chronic fatigue syndrome chronic fatigue syndrome
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years but <65. - Willing and be able to complete all study procedures. - Able to provide informed consent Additional inclusion criteria for ME/CFS patients: - ME/CFS patients must meet international concensus criteria (ICC) or Canadian consensus criteria (CCC). - A self-reported illness narrative of the development of persistent fatigue. - Existence of 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
Exclusion criteria: Exclusion criteria for all subjects: - 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 anaemia, 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. - 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 pregnant 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. - Having claustrophobia - Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability. 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 - colour blindness 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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular measures: - Values obtained during T1 and T2 during prone and standing conditions of Heart rate (HR), Blood pressure (BP), Oxy- and deoxygenated hemoglobine concentration (oxy-Hb, deoxy-Hb) Neuromuscular measures - Absolute values and changes over time during T1 and T2 of maximal index finger abduction force, voluntary activation of the index finger abductor - Absolute values and changes over time during T3, and T4 of maximal index finger abduction force Cognitive measures: - Absolute values and changes over time during T1 and T2 of reaction times and percentage of correct responses -Absolute values and changes over time during T3 and T4 of reaction times and percentage of correct responses MRI measures during T3 and T4: -BOLD activation at rest and during a cognitive and physical tasks. -Arterial spin labelling (ASL) at rest and during physical task. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes over time, during physical and cognitive task performance of heart rate, blood pressure, oxygen and deoxygenated hemoglobin concentration - Metabolites - Patient-reported outcome measures (PEM questionnaires, Chalder fatigue scale, SSS questionnaire, EQ-5D questionnaire, DPEMQ, SF-36, HADS, Bell_CFDIS scale, COMPASS-31, PSQI, MFIS - Scores of daily activity and sleep patterns: o time spent at different activity intensities and sedentary time. o sleep parameters such as time in bed, sleep time, waking up after sleep onset, waking time. o Heart rate variability (HRV) measured during cognitive and physical tasks in the lab and for 7 days during daily activities - Number of repetitions in the two 30 chair to stand tests (30CST) - Handgrip strength - Knee extensor force Neuromuscular measures - Absolute values and changes over time during T1 vs T2 and T3 vs T4 of the index finger abductor force decline (fatigability) during sustained contraction | — |
Countries
Netherlands
Outcome results
None listed