Clinical trial

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

ID

Name

19CH030

Description

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.

Trial arms

Trial start

2020-01-21

Estimated PCD

2021-06-16

Trial end

2021-07-31

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly 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)

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

Blood sample

Blood sample will be realized to evaluate anemia and inflammations.

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

Cardiopulmonary evaluation

Cardiopulmonary evaluation will be realized with a cycle ergometer.

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

Capacity of muscular oxygen extraction

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

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

Sleep assessment

Sleep assessment will be measured by actigraphy during 15 days.

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

Metabolic fatigue

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

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

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

Arms:

Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued

Size

67

Primary endpoint

Voluntary maximum contraction

Day : 30

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}

Updated at

2023-11-02

1 organization

1 product

2 indications

Organization

Centre Hospitalier Universitaire de Saint Etienne

Product

Indication

Indication