Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
NCT ID: NCT03983720
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
67 participants
INTERVENTIONAL
2020-01-21
2021-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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
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.
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)
Blood sample
Blood sample will be realized to evaluate anemia and inflammations.
Cardiopulmonary evaluation
Cardiopulmonary evaluation will be realized with a cycle ergometer.
Capacity of muscular oxygen extraction
Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Sleep assessment
Sleep assessment will be measured by actigraphy during 15 days.
Metabolic fatigue
Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
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
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
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.
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)
Blood sample
Blood sample will be realized to evaluate anemia and inflammations.
Cardiopulmonary evaluation
Cardiopulmonary evaluation will be realized with a cycle ergometer.
Capacity of muscular oxygen extraction
Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Sleep assessment
Sleep assessment will be measured by actigraphy during 15 days.
Metabolic fatigue
Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
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
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
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)
Blood sample
Blood sample will be realized to evaluate anemia and inflammations.
Cardiopulmonary evaluation
Cardiopulmonary evaluation will be realized with a cycle ergometer.
Capacity of muscular oxygen extraction
Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Sleep assessment
Sleep assessment will be measured by actigraphy during 15 days.
Metabolic fatigue
Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
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
Interventions
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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.
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)
Blood sample
Blood sample will be realized to evaluate anemia and inflammations.
Cardiopulmonary evaluation
Cardiopulmonary evaluation will be realized with a cycle ergometer.
Capacity of muscular oxygen extraction
Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Sleep assessment
Sleep assessment will be measured by actigraphy during 15 days.
Metabolic fatigue
Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jean-Philippe CAMDESSANCHE, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU DE SAINT ETIENNE
Locations
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Chu Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2019-A00427-50
Identifier Type: OTHER
Identifier Source: secondary_id
19CH030
Identifier Type: -
Identifier Source: org_study_id
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