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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00427-50 | Other Identifier | ID-RCB |
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low inclusion rates
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with multiple sclerosis and lowly fatigued | Experimental | Patient with multiple sclerosis and lowly fatigued will be included. They will have: Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue |
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| Patient with multiple sclerosis and highly fatigued | Experimental | Patient with multiple sclerosis and highly fatigued will be included. They will have: Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue |
|
| Healthy subjects | Active Comparator | Healthy subjects will be included. They will have: Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of degree chronic fatigue. | Other | Evaluation of degree chronic fatigue with the results of survey Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS). This result will allow to divide patients in groups : lowly fatigued and highly fatigued. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular function during the dynamic strenuous exercise | Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials . | Day : 30 |
| Muscle oxygen extraction capacity |
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Inclusion Criteria:
For Patients:
For Healthy volunteers:
Exclusion Criteria:
For Patients and Healthy volunteers:
For Patients only:
For Healthy volunteers:
- Neurological diseases, cardiovascular, musculoskeletal
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe CAMDESSANCHE, MD PhD | CHU DE SAINT ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | France |
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| Questionnaires | Other |
|
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| Blood sample | Biological | Blood sample will be realized to evaluate anemia and inflammations. |
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| Cardiopulmonary evaluation | Other | Cardiopulmonary evaluation will be realized with a cycle ergometer. |
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| Capacity of muscular oxygen extraction | Device | Measure the capacity of muscular oxygen extraction with a cycle ergometer. |
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| Sleep assessment | Device | Sleep assessment will be measured by actigraphy during 15 days. |
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| Metabolic fatigue | Device | Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI). |
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| Neuromuscular evaluation | Other | Neuromuscular evaluation will be measured by the composite of the results of:
|
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Measured by near-infrared spectroscopy (NIRS)
| Day : 30 |
| Anemia | Measured by blood count in blood sample | Day : 30 |
| Inflammation | Measured by C-reactiv protein in blood sample | Day : 30 |
| VO2 max | Measured by effort test | Day : 30 |
| Heart rate | Measured by heart rate monitor | Day : 30 |
| Cognitive fatigue | Measured by Symbol Digit Modalities Test | Day : 30 |
| Perceived fatigue | Measured by Borg scale | Day : 30 |
| Thermoregulation | Measured by digestible thermometric pill (e-celcius Performance) | Day : 30 |
| Sleep quality | Measured by actigraphy | Day : 30 |
| Muscle volume | Measured by Magnetic Resonance Imaging | Day : 30 |
| Metabolic fatigue | Measured by a Phosphorus 31 Nuclear Magnetic Resonance test | Day : 30 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
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