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

NCT ID: NCT04220814

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2025-11-05

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.

Detailed Description

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".

The impact of the precise localisation of focal MS lesions on certain circuits particularly involved in ambulation, such as pyramidal or proprioceptive beams, has however been little studied in imaging, mainly due to technical limitations. Indeed, such studies require the acquisition of brain and spinal cord MRI images of sufficient spatial resolution to allow the localisation of focal lesions and pathways. Several previous studies have shown encouraging results by separately studying damage to the brain or spinal cord portion of the corticospinal bundle and relating it to disability. To our knowledge, no studies have analysed the lesional involvement of the cortico-spinal bundle or the entire proprioceptive bundle from the motor cortex to the medullary cone in patients with MS.

In a preliminary study, we studied the cerebral spinal cortex and cervical spinal cord bundle using data from the PHRC 2012 EMISEP and obtained encouraging results. In particular, we have shown that the cortico-spinal pathways are very frequently affected by focal lesions in the early years of the disease and that it is already correlated with the functional consequences in patients measured clinically and in electrophysiology.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients

Group Type: EXPERIMENTAL

MRI

Intervention Type: 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

Electrophysiology

Intervention Type: OTHER

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

Healthy Volunteer

Group Type: OTHER

MRI

Intervention Type: 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

Electrophysiology

Intervention Type: OTHER

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

Interventions

MRI

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

Intervention Type: RADIATION

Electrophysiology

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphael Chouteau, Md

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

AP-HM Timone

Marseille, , France

CHU Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC19_9769_MS-TRACTS

Identifier Type: -

Identifier Source: org_study_id