NCT03983720

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

June 7, 2019

Last Update Submit

October 31, 2023

Conditions

Sclerosis, Multiple

Keywords

Sleep assessmentNeuromuscular FatigabilityMultiple sclerosisChronic fatigue

Outcome Measures

Primary Outcomes (1)

  • Voluntary maximum contraction

    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)

    Day : 30

Secondary Outcomes (12)

  • Neuromuscular function during the dynamic strenuous exercise

    Day : 30

  • Muscle oxygen extraction capacity

    Day : 30

  • Anemia

    Day : 30

  • Inflammation

    Day : 30

  • VO2 max

    Day : 30

  • +7 more secondary outcomes

Study Arms (3)

Patient with multiple sclerosis and lowly fatigued

EXPERIMENTAL

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.Other: QuestionnairesBiological: Blood sampleOther: Cardiopulmonary evaluationDevice: Capacity of muscular oxygen extractionDevice: Sleep assessmentDevice: Metabolic fatigueOther: Neuromuscular evaluation

Patient with multiple sclerosis and highly fatigued

EXPERIMENTAL

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.Other: QuestionnairesBiological: Blood sampleOther: Cardiopulmonary evaluationDevice: Capacity of muscular oxygen extractionDevice: Sleep assessmentDevice: Metabolic fatigueOther: Neuromuscular evaluation

Healthy subjects

ACTIVE COMPARATOR

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: QuestionnairesBiological: Blood sampleOther: Cardiopulmonary evaluationDevice: Capacity of muscular oxygen extractionDevice: Sleep assessmentDevice: Metabolic fatigueOther: Neuromuscular evaluation

Interventions

Evaluation of degree chronic fatigue.OTHER

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.

Patient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
QuestionnairesOTHER

* 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)

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
Blood sampleBIOLOGICAL

Blood sample will be realized to evaluate anemia and inflammations.

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
Cardiopulmonary evaluationOTHER

Cardiopulmonary evaluation will be realized with a cycle ergometer.

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
Capacity of muscular oxygen extractionDEVICE

Measure the capacity of muscular oxygen extraction with a cycle ergometer.

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
Sleep assessmentDEVICE

Sleep assessment will be measured by actigraphy during 15 days.

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
Metabolic fatigueDEVICE

Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued
Neuromuscular evaluationOTHER

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

Healthy subjectsPatient with multiple sclerosis and highly fatiguedPatient with multiple sclerosis and lowly fatigued

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Surveys and QuestionnairesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Officials

  • Jean-Philippe CAMDESSANCHE, MD PhD

    CHU DE SAINT ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 12, 2019

Study Start

January 21, 2020

Primary Completion

June 16, 2021

Study Completion

July 31, 2021

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)