Sclerosis, Multiple Clinical Trial
— FatSEPOfficial title:
Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Verified date | October 2023 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life. The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.
Status | Terminated |
Enrollment | 67 |
Est. completion date | July 31, 2021 |
Est. primary completion date | June 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: For Patients: - Aged = 18 and = 70 years - Men or women - With multiple sclerosis since 2 and 25 years - Affiliates or beneficiaries of social security scheme - Signed consent For Healthy volunteers: - Aged = 18 and = 70 years - Men or women - Matched in accordance with age, sex and level of physical activity Exclusion Criteria: For Patients and Healthy volunteers: - High heart rate resting - Blood pressure > 144/94 mmHg - Recent adjustment of drug or drug can have an impact on fatigue or stimulant for fatigue - Taking neuroactive substances that can alter corticospinal excitability - Contraindication at application magnetic field - Contraindication at Magnetic Resonance Imaging (MRI) - Currently participating in a structured exercise program - Pregnant For Patients only: - Spasticity or cerebellar ataxia - Abnormal range of motion (toe and/or ankle) - Musculoskeletal injuries that impedes pedaling - Appearance of symptoms of multiple sclerosis in the 90 days preceding the study For Healthy volunteers: - Neurological diseases, cardiovascular, musculoskeletal |
Country | Name | City | State |
---|---|---|---|
France | Chu Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Voluntary maximum contraction | Comparison the percentage of decrease in voluntary maximum contraction reported after the fatiguing task. Measured by an instrumented measuring pedal (PowerForce pedal, Model PF1.0.0.0, Radlabor GmbH, Freiburg, Germany) | Day : 30 | |
Secondary | Neuromuscular function during the dynamic strenuous exercise | Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials
. |
Day : 30 | |
Secondary | Muscle oxygen extraction capacity | Measured by near-infrared spectroscopy (NIRS) | Day : 30 | |
Secondary | Anemia | Measured by blood count in blood sample | Day : 30 | |
Secondary | Inflammation | Measured by C-reactiv protein in blood sample | Day : 30 | |
Secondary | VO2 max | Measured by effort test | Day : 30 | |
Secondary | Heart rate | Measured by heart rate monitor | Day : 30 | |
Secondary | Cognitive fatigue | Measured by Symbol Digit Modalities Test | Day : 30 | |
Secondary | Perceived fatigue | Measured by Borg scale | Day : 30 | |
Secondary | Thermoregulation | Measured by digestible thermometric pill (e-celcius Performance) | Day : 30 | |
Secondary | Sleep quality | Measured by actigraphy | Day : 30 | |
Secondary | Muscle volume | Measured by Magnetic Resonance Imaging | Day : 30 | |
Secondary | Metabolic fatigue | Measured by a Phosphorus 31 Nuclear Magnetic Resonance test | Day : 30 |
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