Evaluation of the Impact of Lesions of the Motor and Proprioceptive Brain and Pan-medullary Pathways on Their Clinically and Electrophysiologically Assessed Function in Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT04220814

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • MRI
  • Electrophysiology

What it measured

Main measures

  • association ratio between EDSS score and focal injury fraction at inclusion

    24 months

    Disability progressionMRI lesions

Other measures (12)

  • Correlation between focal lesion load and changes in Expanded Disability Status Scale (EDSS)

    24 months

    Disability progressionMRI lesions
  • Correlation between the severity of lesions and changes in Expanded Disability Status Scale (EDSS)

    24 months

    Disability progressionMRI lesionsMyelin repair
  • Differences in central conduction times between patients and healthy volunteers

    1 day

    Myelin repair
  • Correlation between focal lesion load and changes in Timed 25-Foot Walk Test (T25W)

    24 months

    Disability progressionMRI lesionsWalking and mobility
  • Correlation between the severity of lesions and changes in Timed 25-Foot Walk Test (T25W)

    24 months

    Disability progressionMRI lesionsMyelin repairWalking and mobility
  • Correlation between focal lesion load and changes in Nine Hole Peg Test (9HPT)

    24 months

    Disability progressionMRI lesionsArm and hand function
  • Correlation between the severity of lesions and changes in Nine Hole Peg Test (9HPT)

    24 months

    Disability progressionMRI lesionsMyelin repairArm and hand function
  • Correlation between focal lesion load and changes in walking distance

    24 months

    MRI lesionsWalking and mobility
  • Correlation between the severity of lesions and changes in walking distance

    24 months

    MRI lesionsMyelin repairWalking and mobility
  • Correlation between focal lesion load and changes in 12-Item Multiple Sclerosis Walking Scale (MSWS12) score

    24 months

    MRI lesionsWalking and mobilityPainMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over · EDSS 0 to 4

Show the full criteria

Inclusion criteria

Patients : * More than 18 years old * relapsing-remitting multiple sclerosis according to Mac Donald criteria (2010) * EDSS score at the inclusion from 0 to 4 * With at least 1 symptom of pyramidal injury during clinical exam * Written informed consent * Affiliated to a Health Care system Healthy Volunteers: * More than 18 years old * Written informed consent * Affiliated to a Health Care system

Exclusion criteria

Patients * progressive MS ; * Corticoids during the last 60 days before inclusion ; * Other neurological disease or Other progressive systemic disease * adults subject to legal protection or persons deprived of liberty * Contraindications to MRI * Contraindications to motor evoked potentials * Current pregnancy or breast-feeding Healthy volunteers: * History of disease affecting central nervous system * Familial history of MS * History of medullar injury * Spinal osteoarthritis which can lead to a spinal hypersignal ; * adults subject to legal protection or persons deprived of liberty * Contraindications to MRI * Contraindications to motor evoked potentials * Current pregnancy or breast-feeding

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

About this trial

In the sponsor's words

Multiple Sclerosis (MS) is the most common acquired neurological disease leading to disability, especially ambulatory, in young adults. To date, the correlation between the number or volume of white matter lesions seen on conventional MRI and the degree of disability of patients remains low to moderate. This phenomenon is known as the "clinical-radiological paradox". In this new project, we hypothesize that an evaluation of the corticospinal pathways including their thoracic medullary portion, as well as taking into account the severity of the lesions using quantitative MRI, will allow the investigators to refine the correlation with ambulatory disability in MS patients. We will complete the evaluation of motor pathways with those of the proprioceptive pathways also strongly involved in ambulation.

Papers

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History

    1. Started

      Nov 2020

    2. Main results due

      Oct 2023

    3. Finished

      Nov 2025

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