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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03983720
Other study ID # 19CH030
Secondary ID 2019-A00427-50
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 21, 2020
Est. completion date July 31, 2021

Study information

Verified date October 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 67
Est. completion date July 31, 2021
Est. primary completion date June 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
Sleep assessment
Sleep assessment will be measured by actigraphy during 15 days.
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

Locations

Country Name City State
France Chu Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Neuromuscular function during the dynamic strenuous exercise Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials
.
Day : 30
Secondary Muscle oxygen extraction capacity Measured by near-infrared spectroscopy (NIRS) Day : 30
Secondary Anemia Measured by blood count in blood sample Day : 30
Secondary Inflammation Measured by C-reactiv protein in blood sample Day : 30
Secondary VO2 max Measured by effort test Day : 30
Secondary Heart rate Measured by heart rate monitor Day : 30
Secondary Cognitive fatigue Measured by Symbol Digit Modalities Test Day : 30
Secondary Perceived fatigue Measured by Borg scale Day : 30
Secondary Thermoregulation Measured by digestible thermometric pill (e-celcius Performance) Day : 30
Secondary Sleep quality Measured by actigraphy Day : 30
Secondary Muscle volume Measured by Magnetic Resonance Imaging Day : 30
Secondary Metabolic fatigue Measured by a Phosphorus 31 Nuclear Magnetic Resonance test Day : 30
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