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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03983720
Acronym
FatSEP
Enrollment
67
Registered
2019-06-12
Start date
2020-01-21
Completion date
2021-07-31
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sclerosis, Multiple

Keywords

Sleep assessment, Neuromuscular Fatigability, Multiple sclerosis, Chronic fatigue

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.

Interventions

OTHEREvaluation 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.

OTHERQuestionnaires

* 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)

BIOLOGICALBlood sample

Blood sample will be realized to evaluate anemia and inflammations.

OTHERCardiopulmonary evaluation

Cardiopulmonary evaluation will be realized with a cycle ergometer.

DEVICECapacity of muscular oxygen extraction

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

DEVICESleep assessment

Sleep assessment will be measured by actigraphy during 15 days.

DEVICEMetabolic fatigue

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

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Voluntary maximum contractionDay : 30Comparison 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

MeasureTime frameDescription
Muscle oxygen extraction capacityDay : 30Measured by near-infrared spectroscopy (NIRS)
AnemiaDay : 30Measured by blood count in blood sample
InflammationDay : 30Measured by C-reactiv protein in blood sample
VO2 maxDay : 30Measured by effort test
Heart rateDay : 30Measured by heart rate monitor
Neuromuscular function during the dynamic strenuous exerciseDay : 30Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials .
Perceived fatigueDay : 30Measured by Borg scale
ThermoregulationDay : 30Measured by digestible thermometric pill (e-celcius Performance)
Sleep qualityDay : 30Measured by actigraphy
Muscle volumeDay : 30Measured by Magnetic Resonance Imaging
Metabolic fatigueDay : 30Measured by a Phosphorus 31 Nuclear Magnetic Resonance test
Cognitive fatigueDay : 30Measured by Symbol Digit Modalities Test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026