NCT03983720

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sclerosis, Multiple

Interventions

Type	Name	Description
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	* Fatigue Severity Scale (FSS) * Modified Fatigue Impact Scale (MFIS) * Godin Leisure-Time Exercise Questionnaire (GLTEQ) * Scale of life quality of multiple sclerosis (SEP-59) * Center for Epidemiologic Studies Depression (CES-D) * Pittsburgh Sleep Quality Index (PSQ-I)
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: * Fatigue test * Measure of voluntary isometric force * Surface electromyography * Peripheral nerve stimulation * Transcranial Magnetic Stimulation (TMS) * Perceived fatigue * Cognitive fatigue * Thermoregulation

Timeline

• Start date: 2020-01-21
• Primary completion: 2021-06-16
• Completion: 2021-07-31
• First posted: 2019-06-12
• Last updated: 2023-11-02

Locations

1 site across 1 country: France