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

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ClinicalTrials.gov Identifier: NCT03983720
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Sclerosis, Multiple Other: Evaluation of degree chronic fatigue. Other: Questionnaires Biological: Blood sample Other: Cardiopulmonary evaluation Device: Capacity of muscular oxygen extraction Device: Sleep assessment Device: Metabolic fatigue Other: Neuromuscular evaluation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient with multiple sclerosis and lowly fatigued

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.
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

Experimental: Patient with multiple sclerosis and highly fatigued

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.
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

Active Comparator: Healthy subjects

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: 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




Primary Outcome Measures :
  1. Voluntary maximum contraction [ Time Frame: Day : 30 ]
    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 :
  1. Neuromuscular function during the dynamic strenuous exercise [ Time Frame: Day : 30 ]

    Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials

    .


  2. Muscle oxygen extraction capacity [ Time Frame: Day : 30 ]
    Measured by near-infrared spectroscopy (NIRS)

  3. Anemia [ Time Frame: Day : 30 ]
    Measured by blood count in blood sample

  4. Inflammation [ Time Frame: Day : 30 ]
    Measured by C-reactiv protein in blood sample

  5. VO2 max [ Time Frame: Day : 30 ]
    Measured by effort test

  6. Heart rate [ Time Frame: Day : 30 ]
    Measured by heart rate monitor

  7. Cognitive fatigue [ Time Frame: Day : 30 ]
    Measured by Symbol Digit Modalities Test

  8. Perceived fatigue [ Time Frame: Day : 30 ]
    Measured by Borg scale

  9. Thermoregulation [ Time Frame: Day : 30 ]
    Measured by digestible thermometric pill (e-celcius Performance)

  10. Sleep quality [ Time Frame: Day : 30 ]
    Measured by actigraphy

  11. Muscle volume [ Time Frame: Day : 30 ]
    Measured by Magnetic Resonance Imaging

  12. Metabolic fatigue [ Time Frame: Day : 30 ]
    Measured by a Phosphorus 31 Nuclear Magnetic Resonance test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983720


Contacts
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Contact: Jean-Philippe CAMDESSANCHE, MD PhD (0)477120559 ext +33 j.philippe.camdessanche@chu-st-etienne.fr
Contact: Amandine BAUDOT, CRA (0)477829450 ext +33 amandine.baudot@chu-st-etienne.fr

Locations
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France
Chu Saint-Etienne Not yet recruiting
Saint-Étienne, France
Principal Investigator: Jean-Philippe CAMDESSANCHE, MD PhD         
Sub-Investigator: Florence ROBERT-VARVAT, MD         
Sub-Investigator: Arnaud LACOUR, MD         
Sub-Investigator: Laure MAZZOLA, MD         
Sub-Investigator: Mélanie FORESTIER, MD         
Sub-Investigator: Pierre CROISILLE, MD PhD         
Sub-Investigator: Léonard FEASSON, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Jean-Philippe CAMDESSANCHE, MD PhD CHU DE SAINT ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03983720     History of Changes
Other Study ID Numbers: 19CH030
2019-A00427-50 ( Other Identifier: ID-RCB )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Sleep assessment
Neuromuscular Fatigability
Multiple sclerosis
Chronic fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms