Can Fatigability Neuromuscular Explain Chronic Fatigue in People With

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

Stopped earlyPhase 2MS (type not specified)NCT03983720

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: low inclusion rates

This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Evaluation of degree chronic fatigue.

Given to everyone in the trial

  • Questionnaires
  • Blood sample
  • Cardiopulmonary evaluation
  • Capacity of muscular oxygen extraction
  • Sleep assessment
  • Metabolic fatigue
  • Neuromuscular evaluation

What it measured

Main measures

  • Voluntary maximum contraction

    Day : 30

Other measures (12)

  • Neuromuscular function during the dynamic strenuous exercise

    Day : 30

    Physical functionNerve conduction tests

  • Muscle oxygen extraction capacity

    Day : 30

  • Anemia

    Day : 30

  • Inflammation

    Day : 30

  • VO2 max

    Day : 30

    Physical function

  • Heart rate

    Day : 30

  • Cognitive fatigue

    Day : 30

    Thinking and memoryFatigue

  • Perceived fatigue

    Day : 30

    Fatigue

  • Thermoregulation

    Day : 30

  • Sleep quality

    Day : 30

    Mood and sleep

Who could take part

MS (type not specified) · 18 to 70

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2020

    2. Main results due

      Jun 2021

    3. Finished

      Jul 2021

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