Evaluating muscle function and fatigue in multiple sclerosis patients
Non-invasive Evaluation of Muscle Oxidative Capacity. Study of Its Relationship With Muscular Endurance and Fatigue in Patients With Multiple Sclerosis
This study is testing if better muscle oxygen levels can help people with multiple sclerosis have more endurance and less fatigue over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06083194 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between muscle oxidative capacity and muscular endurance in patients with multiple sclerosis (MS). Using near-infrared spectroscopy (NIRS), the study will measure muscle oxygenation and calculate maximal muscle oxidative capacity (mVO2) through non-invasive methods. The investigators hypothesize that higher mVO2 correlates with better muscular endurance and lower fatigue levels. Participants will be monitored over a six-month period to evaluate changes in these parameters.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with multiple sclerosis who have a specific disability status and meet certain health criteria.
Not a fit: Patients with severe psychiatric conditions or unstable cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of fatigue and endurance in multiple sclerosis patients.
How similar studies have performed: Previous studies have shown mixed results regarding muscle oxidative capacity in MS, indicating that this approach is both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Multiple Sclerosis (MS) with a diagnosis established by MRI. * Patients with a Kurtzke Expanded Disability Status Scale (EDSS) score \< 5. * Body mass index (BMI) \< 30 Kg/m². * Thickness of subcutaneous adipose tissue at the calf ≤ 20 mm. * MS patients without neurological signs of flare-up since 1 month. * MS patients who have not had any treatment modification during the last 2 months. * Subjects affiliated to French health care system (for France). * Volunteers who have given their written consent. Exclusion Criteria: * Patients suffering from progressive psychiatric pathologies (active psychosis, , etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.). * People with poorly controlled or unstable cardiovascular disease. * Major osteoarticular or neurological problems completely preventing the proper performance of the various tests. * Persons under guardianship, curatorship, deprived of liberty or safeguarding justice. * Pregnant or lactating women.
Where this trial is running
Clermont-Ferrand
- CHU clermont-ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Fréderic COSTES — fcostes@chu-clermontferrand.fr
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.