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

NCT03983720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-11-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Jean-Philippe CAMDESSANCHE, MD PhD · CHU DE SAINT ETIENNE

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2021-06-16
Completion
2021-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983720 on ClinicalTrials.gov