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

NCT04220814 | Completed

• 1 other identifier: 35RC19_9769_MS-TRACTS
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple sclerosis; MRI; pronostic

Outcome Measures

Primary Outcomes (1)

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

  EDSS score is a specific multiple sclerosis scale, named Expanded Disability Status Scale, from 0 (normal neurological status) to 10 (death kinked to sclerosis). Focal injury fraction is focal injury volume divided by the volume of goal zone and will be assessed by MRI analysis.

  24 months

Secondary Outcomes (12)

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

  24 months

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

  24 months

• Differences in central conduction times between patients and healthy volunteers

  1 day

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

  24 months

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

  24 months

Study Arms (2)

Patients

EXPERIMENTAL

Radiation: MRI; Other: Electrophysiology

Healthy Volunteer

OTHER

Radiation: MRI; Other: Electrophysiology

Interventions

MRI RADIATION

MRI protocol is different, a little bit longer than MRI in routine for patients. For healthy volunteer, a specific MRI for this study is done

Healthy Volunteer; Patients

Electrophysiology OTHER

Electrophysiology will be done during routine visits for patients and during inclusion visit to healthy volunteers

Healthy Volunteer; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients :
• More than 18 years old
• relapsing-remitting multiple sclerosis according to Mac Donald criteria (2010)
• 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

You may not qualify if:

• Patients
• progressive MS ;
• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

AP-HM Timone

Marseille, France

Location

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Raphael Chouteau, Md

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: November 3, 2020
• Primary Completion: October 3, 2023
• Study Completion: November 5, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)