Clinical trial NCT03983720: Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Official title: Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sclerosis, Multiple
Keywords: Sleep assessment
Neuromuscular Fatigability
Multiple sclerosis
Chronic fatigue
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Voluntary maximum contraction
timeFrame: Day : 30
Secondary outcomes:
measure: Neuromuscular function during the dynamic strenuous exercise
timeFrame: Day : 30
measure: Muscle oxygen extraction capacity
timeFrame: Day : 30
measure: Anemia
timeFrame: Day : 30
measure: Inflammation
timeFrame: Day : 30
measure: VO2 max
timeFrame: Day : 30
measure: Heart rate
timeFrame: Day : 30
measure: Cognitive fatigue
timeFrame: Day : 30
measure: Perceived fatigue
timeFrame: Day : 30
measure: Thermoregulation
timeFrame: Day : 30
measure: Sleep quality
timeFrame: Day : 30
measure: Muscle volume
timeFrame: Day : 30
measure: Metabolic fatigue
timeFrame: Day : 30
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU DE SAINT ETIENNE
name: Jean-Philippe CAMDESSANCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: