Multiple Sclerosis, Relapsing-RemittingMS-TRACTSNCT04220814
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
A study testing MRI and Electrophysiology in people with Multiple Sclerosis, Relapsing-Remitting, run by Rennes University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- MRI and Electrophysiology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Nov 2020to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Affiliated to a Health Care system
- Healthy Volunteers:
- More than 18 years old
- Written informed consent
- Affiliated to a Health Care system
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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
- Being tested
- MRI, Electrophysiology
- Keywords
- Multiple sclerosis, MRI, pronostic
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
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
ElectrophysiologyOther
Electrophysiology will be done during routine visits for patients and during inclusion visit to healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Radiation: MRI; Other: Electrophysiology |
| Healthy Volunteer | Other | Not described Receives: Radiation: MRI; Other: Electrophysiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (12)
Correlation between focal lesion load and changes in Expanded Disability Status Scale (EDSS)
Correlation between focal lesion load and changes in Expanded Disability Status Scale (EDSS) during patients follow up. The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Measured: 24 months
Correlation between the severity of lesions and changes in Expanded Disability Status Scale (EDSS)
Correlation between the severity of lesions and changes in Expanded Disability Status Scale (EDSS) during patients follow up. The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
The severity of the lesions will be assessed by the volume of the focal lesion load on the motor and sensory pathways, and by the value of the average magnetization transfer ratio (MTR) within the lesions
Measured: 24 months
Differences in central conduction times between patients and healthy volunteers
Significance of the differences in central conduction time values of motor and somaesthetic evoked potentials and in mean MTR values of motor and sensory pathways, between patients and healthy volunteers. Central conduction time values of motor and somaesthetic evoked potentials in healthy subjects and patients as well as on the averages of MTR (magnetic transfer ratio) values of motor and sensory pathways at the encephalic and medullary level, between patients and healthy volunteers
Measured: 1 day
Correlation between focal lesion load and changes in Timed 25-Foot Walk Test (T25W)
Correlation between focal lesion load and changes in Timed 25-Foot Walk Test (T25W) during patients follow up. The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible. he task is immediately administered again by having the patient walk back the same distance. The score for the T25-FWis the average of the two completed trials.
Measured: 24 months
Correlation between the severity of lesions and changes in Timed 25-Foot Walk Test (T25W)
Correlation between the severity of lesions and changes in Timed 25-Foot Walk Test (T25W) during patients follow up. The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible. he task is immediately administered again by having the patient walk back the same distance. The score for the T25-FWis the average of the two completed trials.The severity of the lesions will be assessed by the volume of the focal lesion load on the motor and sensory pathways, and by the value of the average magnetization transfer ratio (MTR) within the lesions
Measured: 24 months
Correlation between focal lesion load and changes in Nine Hole Peg Test (9HPT)
Correlation between focal lesion load and changes in Nine Hole Peg Test (9HPT) during patients follow up. The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnose. Scores are based on the time taken to complete the test activity, recorded in seconds
Measured: 24 months
Correlation between the severity of lesions and changes in Nine Hole Peg Test (9HPT)
Correlation between the severity of lesions and changes in Nine Hole Peg Test (9HPT) during patients follow up. The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnose. Scores are based on the time taken to complete the test activity, recorded in seconds. The severity of the lesions will be assessed by the volume of the focal lesion load on the motor and sensory pathways, and by the value of the average magnetization transfer ratio (MTR) within the lesions
Measured: 24 months
Correlation between focal lesion load and changes in walking distance
Correlation between focal lesion load and changes in walking distance using 6-minutes walk test (6MWT) during patients follow up. The score of the test is the distance a patient walks in 6 minutes.
Measured: 24 months
Correlation between the severity of lesions and changes in walking distance
Correlation between the severity of lesions and changes in walking distance using 6-minutes walk test (6MWT) during patients follow up. The score of the test is the distance a patient walks in 6 minutes. The severity of the lesions will be assessed by the volume of the focal lesion load on the motor and sensory pathways, and by the value of the average magnetization transfer ratio (MTR) within the lesions
Measured: 24 months
Correlation between focal lesion load and changes in 12-Item Multiple Sclerosis Walking Scale (MSWS12) score
Correlation between focal lesion load and changes in 12-Item Multiple Sclerosis Walking Scale (MSWS12) during patients follow up. The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a patient-reported outcome that assesses the impact of walking impairment in people with multiple sclerosis. The EQ-5D-3L is a validated, generic, preference-based, health-status measure consisting of five descriptive questions encompassing five domains of HRQoL (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each question is answered based on three response options (1= "no problems", 2= "moderate problems", 3= "severe problems"), with the 243 potential patterns of responses enabling classification of a participant into a distinct health state associated with a specific index score.
Measured: 24 months
Correlation between the severity of lesions and all limbs electrophysiology parameters
Correlation between the severity of lesions and all limbs electrophysiology parameters : Electrophysiology (all 4 limbs) with the central conduction time of motor evoked potentials and the central conduction time of somesthetic evoked potentials. The severity of the lesions will be assessed by the volume of the focal lesion load on the motor and sensory pathways, and by the value of the average magnetization transfer ratio (MTR) within the lesions
Measured: 24 months
Correlation between in focal lesion load of pathways and changes in Expanded Disability Status Scale
The amount of focal lesion load in the motor and proprioceptive pathways will be correlated with the change in Expanded Disability Status Scale (EDSS) score during patients follow up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start3 Nov 2020
- Primary completion3 Oct 2023
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael Chouteau, Md, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220814
- Sponsor's protocol ID
- 35RC19_9769_MS-TRACTS
- Acronym
- MS-TRACTS
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2020
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04220814
- Acronym / sponsor ID
- MS-TRACTS / 35RC19_9769_MS-TRACTS
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple sclerosis, MRI, pronostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Radiation: MRI, Other: Electrophysiology |
| Healthy Volunteer | Other | Radiation: MRI, Other: Electrophysiology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI protocol is different, a little bit longer than MRI in routine for patients. For healthy volunteer, a specific MRI for this study is done | Radiation | Healthy Volunteer, Patients |
| ElectrophysiologyElectrophysiology will be done during routine visits for patients and during inclusion visit to healthy volunteers | Other | Healthy Volunteer, Patients |
Primary outcome
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.
12 secondary outcomes
Correlation between focal lesion load and changes in Expanded Disability Status Scale (EDSS)
Time frame: 24 months
Correlation between the severity of lesions and changes in Expanded Disability Status Scale (EDSS)
Time frame: 24 months
Differences in central conduction times between patients and healthy volunteers
Time frame: 1 day
Correlation between focal lesion load and changes in Timed 25-Foot Walk Test (T25W)
Time frame: 24 months
Correlation between the severity of lesions and changes in Timed 25-Foot Walk Test (T25W)
Time frame: 24 months
Correlation between focal lesion load and changes in Nine Hole Peg Test (9HPT)
Time frame: 24 months
Correlation between the severity of lesions and changes in Nine Hole Peg Test (9HPT)
Time frame: 24 months
Correlation between focal lesion load and changes in walking distance
Time frame: 24 months
Correlation between the severity of lesions and changes in walking distance
Time frame: 24 months
Correlation between focal lesion load and changes in 12-Item Multiple Sclerosis Walking Scale (MSWS12) score
Time frame: 24 months
Correlation between the severity of lesions and all limbs electrophysiology parameters
Time frame: 24 months
Correlation between in focal lesion load of pathways and changes in Expanded Disability Status Scale
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Chouteau, Md principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Electrophysiology in people with Multiple Sclerosis, Relapsing-Remitting, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association ratio between EDSS score and focal injury fraction at inclusion (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.