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

Primary Purpose

Sclerosis, Multiple

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Evaluation of degree chronic fatigue.
Questionnaires
Blood sample
Cardiopulmonary evaluation
Capacity of muscular oxygen extraction
Sleep assessment
Metabolic fatigue
Neuromuscular evaluation
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sclerosis, Multiple focused on measuring Sleep assessment, Neuromuscular Fatigability, Multiple sclerosis, Chronic fatigue

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Chu Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Patient with multiple sclerosis and lowly fatigued

Patient with multiple sclerosis and highly fatigued

Healthy subjects

Arm 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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Neuromuscular function during the dynamic strenuous exercise
Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials .
Muscle oxygen extraction capacity
Measured by near-infrared spectroscopy (NIRS)
Anemia
Measured by blood count in blood sample
Inflammation
Measured by C-reactiv protein in blood sample
VO2 max
Measured by effort test
Heart rate
Measured by heart rate monitor
Cognitive fatigue
Measured by Symbol Digit Modalities Test
Perceived fatigue
Measured by Borg scale
Thermoregulation
Measured by digestible thermometric pill (e-celcius Performance)
Sleep quality
Measured by actigraphy
Muscle volume
Measured by Magnetic Resonance Imaging
Metabolic fatigue
Measured by a Phosphorus 31 Nuclear Magnetic Resonance test

Full Information

First Posted
June 7, 2019
Last Updated
June 16, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03983720
Brief Title
Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Acronym
FatSEP
Official Title
Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sclerosis, Multiple
Keywords
Sleep assessment, Neuromuscular Fatigability, Multiple sclerosis, Chronic fatigue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with multiple sclerosis and lowly fatigued
Arm Type
Experimental
Arm 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
Arm Title
Patient with multiple sclerosis and highly fatigued
Arm Type
Experimental
Arm 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
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Evaluation of degree chronic fatigue.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Blood sample will be realized to evaluate anemia and inflammations.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary evaluation
Intervention Description
Cardiopulmonary evaluation will be realized with a cycle ergometer.
Intervention Type
Device
Intervention Name(s)
Capacity of muscular oxygen extraction
Intervention Description
Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Intervention Type
Device
Intervention Name(s)
Sleep assessment
Intervention Description
Sleep assessment will be measured by actigraphy during 15 days.
Intervention Type
Device
Intervention Name(s)
Metabolic fatigue
Intervention Description
Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
Intervention Type
Other
Intervention Name(s)
Neuromuscular evaluation
Intervention Description
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
Primary Outcome Measure Information:
Title
Voluntary maximum contraction
Description
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)
Time Frame
Day : 30
Secondary Outcome Measure Information:
Title
Neuromuscular function during the dynamic strenuous exercise
Description
Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials .
Time Frame
Day : 30
Title
Muscle oxygen extraction capacity
Description
Measured by near-infrared spectroscopy (NIRS)
Time Frame
Day : 30
Title
Anemia
Description
Measured by blood count in blood sample
Time Frame
Day : 30
Title
Inflammation
Description
Measured by C-reactiv protein in blood sample
Time Frame
Day : 30
Title
VO2 max
Description
Measured by effort test
Time Frame
Day : 30
Title
Heart rate
Description
Measured by heart rate monitor
Time Frame
Day : 30
Title
Cognitive fatigue
Description
Measured by Symbol Digit Modalities Test
Time Frame
Day : 30
Title
Perceived fatigue
Description
Measured by Borg scale
Time Frame
Day : 30
Title
Thermoregulation
Description
Measured by digestible thermometric pill (e-celcius Performance)
Time Frame
Day : 30
Title
Sleep quality
Description
Measured by actigraphy
Time Frame
Day : 30
Title
Muscle volume
Description
Measured by Magnetic Resonance Imaging
Time Frame
Day : 30
Title
Metabolic fatigue
Description
Measured by a Phosphorus 31 Nuclear Magnetic Resonance test
Time Frame
Day : 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe CAMDESSANCHE, MD PhD
Phone
(0)477120559
Ext
+33
Email
j.philippe.camdessanche@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine BAUDOT, CRA
Phone
(0)477829450
Ext
+33
Email
amandine.baudot@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe CAMDESSANCHE, MD PhD
Organizational Affiliation
CHU DE SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe CAMDESSANCHE, MD PhD
First Name & Middle Initial & Last Name & Degree
Florence ROBERT-VARVAT, MD
First Name & Middle Initial & Last Name & Degree
Arnaud LACOUR, MD
First Name & Middle Initial & Last Name & Degree
Laure MAZZOLA, MD
First Name & Middle Initial & Last Name & Degree
Mélanie FORESTIER, MD
First Name & Middle Initial & Last Name & Degree
Pierre CROISILLE, MD PhD
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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