Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis? (FatSEP)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Terminated; Phase 2

Conditions: Sclerosis, Multiple

Treatments: Biological: Blood sample; Other: Cardiopulmonary evaluation; Other: Questionnaires; Other: Neuromuscular evaluation; Device: Metabolic fatigue; Device: Sleep assessment; Device: Capacity of muscular oxygen extraction; Other: Evaluation of degree chronic fatigue.

Study type: Interventional

Funder types: Other

Identifiers

NCT03983720

19CH030

2019-A00427-50 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 3 patient groups

Patient with multiple sclerosis and lowly fatigued

Experimental group

Description:

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

Treatment:

Device: Capacity of muscular oxygen extraction

Device: Sleep assessment

Other: Neuromuscular evaluation

Device: Metabolic fatigue

Other: Evaluation of degree chronic fatigue.

Other: Cardiopulmonary evaluation

Biological: Blood sample

Other: Questionnaires

Patient with multiple sclerosis and highly fatigued

Experimental group

Description:

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

Treatment:

Device: Capacity of muscular oxygen extraction

Device: Sleep assessment

Other: Neuromuscular evaluation

Device: Metabolic fatigue

Other: Evaluation of degree chronic fatigue.

Other: Cardiopulmonary evaluation

Biological: Blood sample

Other: Questionnaires

Healthy subjects

Active Comparator group

Description:

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

Treatment:

Device: Capacity of muscular oxygen extraction

Device: Sleep assessment

Other: Neuromuscular evaluation

Device: Metabolic fatigue

Other: Cardiopulmonary evaluation

Biological: Blood sample

Other: Questionnaires