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

Sclerosis, Multiple Clinical Trial

— FatSEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03983720
• Other study ID #: 19CH030
• Secondary ID: 2019-A00427-50
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis
• Sclerosis, Multiple

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