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Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis? (FatSEP)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sclerosis, Multiple | Other: Evaluation of degree chronic fatigue. Other: Questionnaires Biological: Blood sample Other: Cardiopulmonary evaluation Device: Capacity of muscular oxygen extraction Device: Sleep assessment Device: Metabolic fatigue Other: Neuromuscular evaluation | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Diagnostic |
| Official Title: | Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis? |
| Actual Study Start Date : | January 21, 2020 |
| Estimated Primary Completion Date : | November 2021 |
| Estimated Study Completion Date : | November 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Patient with multiple sclerosis and lowly fatigued
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 |
Other: Evaluation of degree chronic fatigue.
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.
Other: Questionnaires
Biological: Blood sample Blood sample will be realized to evaluate anemia and inflammations.
Other: Cardiopulmonary evaluation Cardiopulmonary evaluation will be realized with a cycle ergometer.
Device: Capacity of muscular oxygen extraction Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Device: Sleep assessment Sleep assessment will be measured by actigraphy during 15 days.
Device: Metabolic fatigue Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
Other: Neuromuscular evaluation Neuromuscular evaluation will be measured by the composite of the results of:
|
|
Experimental: Patient with multiple sclerosis and highly fatigued
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 |
Other: Evaluation of degree chronic fatigue.
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.
Other: Questionnaires
Biological: Blood sample Blood sample will be realized to evaluate anemia and inflammations.
Other: Cardiopulmonary evaluation Cardiopulmonary evaluation will be realized with a cycle ergometer.
Device: Capacity of muscular oxygen extraction Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Device: Sleep assessment Sleep assessment will be measured by actigraphy during 15 days.
Device: Metabolic fatigue Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
Other: Neuromuscular evaluation Neuromuscular evaluation will be measured by the composite of the results of:
|
|
Active Comparator: Healthy subjects
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 |
Other: Questionnaires
Biological: Blood sample Blood sample will be realized to evaluate anemia and inflammations.
Other: Cardiopulmonary evaluation Cardiopulmonary evaluation will be realized with a cycle ergometer.
Device: Capacity of muscular oxygen extraction Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Device: Sleep assessment Sleep assessment will be measured by actigraphy during 15 days.
Device: Metabolic fatigue Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
Other: Neuromuscular evaluation Neuromuscular evaluation will be measured by the composite of the results of:
|
- Voluntary maximum contraction [ Time Frame: Day : 30 ]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)
- Neuromuscular function during the dynamic strenuous exercise [ Time Frame: Day : 30 ]
Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials
.
- Muscle oxygen extraction capacity [ Time Frame: Day : 30 ]Measured by near-infrared spectroscopy (NIRS)
- Anemia [ Time Frame: Day : 30 ]Measured by blood count in blood sample
- Inflammation [ Time Frame: Day : 30 ]Measured by C-reactiv protein in blood sample
- VO2 max [ Time Frame: Day : 30 ]Measured by effort test
- Heart rate [ Time Frame: Day : 30 ]Measured by heart rate monitor
- Cognitive fatigue [ Time Frame: Day : 30 ]Measured by Symbol Digit Modalities Test
- Perceived fatigue [ Time Frame: Day : 30 ]Measured by Borg scale
- Thermoregulation [ Time Frame: Day : 30 ]Measured by digestible thermometric pill (e-celcius Performance)
- Sleep quality [ Time Frame: Day : 30 ]Measured by actigraphy
- Muscle volume [ Time Frame: Day : 30 ]Measured by Magnetic Resonance Imaging
- Metabolic fatigue [ Time Frame: Day : 30 ]Measured by a Phosphorus 31 Nuclear Magnetic Resonance test
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
| Contact: Jean-Philippe CAMDESSANCHE, MD PhD | (0)477120559 ext +33 | j.philippe.camdessanche@chu-st-etienne.fr | |
| Contact: Amandine BAUDOT, CRA | (0)477829450 ext +33 | amandine.baudot@chu-st-etienne.fr |
| France | |
| Chu Saint-Etienne | Recruiting |
| Saint-Étienne, France | |
| Principal Investigator: Jean-Philippe CAMDESSANCHE, MD PhD | |
| Sub-Investigator: Florence ROBERT-VARVAT, MD | |
| Sub-Investigator: Arnaud LACOUR, MD | |
| Sub-Investigator: Laure MAZZOLA, MD | |
| Sub-Investigator: Mélanie FORESTIER, MD | |
| Sub-Investigator: Pierre CROISILLE, MD PhD | |
| Sub-Investigator: Léonard FEASSON, MD PhD | |
| Principal Investigator: | Jean-Philippe CAMDESSANCHE, MD PhD | CHU DE SAINT ETIENNE |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 7, 2019 | ||||||||
| First Posted Date ICMJE | June 12, 2019 | ||||||||
| Last Update Posted Date | April 8, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 21, 2020 | ||||||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Voluntary maximum contraction [ Time Frame: Day : 30 ] 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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis? | ||||||||
| Official Title ICMJE | Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis? | ||||||||
| Brief Summary |
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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Diagnostic |
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| Condition ICMJE | Sclerosis, Multiple | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 2021 | ||||||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03983720 | ||||||||
| Other Study ID Numbers ICMJE | 19CH030 2019-A00427-50 ( Other Identifier: ID-RCB ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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