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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 (MS-TRACTS)

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ClinicalTrials.gov Identifier: NCT04220814
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Radiation: MRI Other: Electrophysiology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : May 28, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients Radiation: 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

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

Healthy Volunteer Radiation: 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

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




Primary Outcome Measures :
  1. association ratio between EDSS score and focal injury fraction at inclusion [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220814


Contacts
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Contact: Raphael Chouteau, Md 2 99 28 42 94 ext 33 raphael.chouteau@chu-rennes.fr
Contact: Elise Bannier, PhD 2.99.28.42.27 ext 33 elise.bannier@chu-rennes.fr

Locations
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France
CHU Rennes Recruiting
Rennes, France
Contact: Raphaël Chouteau, Md    +33 2 99 28 42 94 ext +33    raphael.chouteau@chu-rennes.fr   
Principal Investigator: Raphaël Chouteau, Md         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Raphael Chouteau, Md Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04220814    
Other Study ID Numbers: 35RC19_9769_MS-TRACTS
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Multiple sclerosis
MRI
pronostic
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases