Multiple Sclerosis, Primary ProgressiveMAP-MSNCT04918225
Motor Asymmetry in Progressive Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, Primary Progressive and Multiple Sclerosis, Secondary Progressive, run by Rennes University Hospital at 1 site in France.
Trial summary
Project Rational A better understanding of the causes of physical disability is an important unmet need in progressive Multiple Sclerosis patients. Progressive Multiple Sclerosis patients most often present a worsening pyramidal syndrome of lower and, to a lesser extent, upper limbs (Lublin et al., 2014) suggesting a… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- What is being tested?
- Magnetic Resonance Imaging, Neurological examination and Multiple Sclerosis Functional Composite
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2021to 10 Feb 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patient population will consist of progressive Multiple Sclerosis patients (both Primary Progressive Multiple Sclerosis and Secondary Progressive Multiple Sclerosis), a population for whom a better understanding of the causes of disability is an unmet need.
- - Inclusion Criteria: 1.1/ Patients:
- Aged between 18 and 60 years.
- Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by Mac Donald revised criteria in 2017.
- Expanded Disability Status Scale lower or equal to 8.0, at inclusion.
- asymmetric motor deficit. The motor deficit asymmetry will be defined by a difference of 3 or more at the American Society Injury. Association motor sub-score per limb between the right lower limb and the left lower limb.
- No evidence of focal inflammatory activity for at least 3 years (no clinical relapse, no gadolinium enhancement on an Magnetic Resonance Imaging scan and no new T2 lesion)
- Provided written informed consent according to the Institutional review board approval
- Affiliated to the French healthcare system. 1.2 / Controls:
- Aged between 18 and 60 years, sex and age matched with patients.
- Provided written informed consent according to the Institutional review board approval
- Affiliated to the French healthcare system.
- - Non-inclusion criteria:
2.1 /Patients:
- cerebellar Expanded Disability Status Scale sub score higher than pyramidal Expanded Disability Status Scale sub score.
- Relapse or corticosteroids in the 30 days preceding inclusion.
- Other neurological diseases.
- Lack of ability to understand the Institutional review board consent form.
- Magnetic Resonance contraindications.
- Pregnancy and breastfeeding.
- Major persons subject to legal protection (legal safeguards, guardianship,curatorship), persons deprived of their liberty
2.2 / Controls:
- Personal history of central nervous related disease
- Familial history of Multiple Sclerosis.
- Personal history of spinal cord injury.
- Personal history of spondylotic myelopathy.
- Magnetic Resonance Imaging contraindication.
- Lack of ability to understand the Institutional review board form.
- Major persons subject to legal protection (legal safeguards, guardianship, curatorship), persons deprived of their liberty
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Project Rational
A better understanding of the causes of physical disability is an important unmet need in progressive Multiple Sclerosis patients. Progressive Multiple Sclerosis patients most often present a worsening pyramidal syndrome of lower and, to a lesser extent, upper limbs (Lublin et al., 2014) suggesting a strong corticospinal tract involvement. The systematic high resolution Magnetic Resonance Imaging exploration of lesions location and severity, as well as extra-lesional tissue, on pan-medullar and encephalic motor tracts offers the opportunity to better understand the pathological mechanism associated with motor impairment.
Read more
Scientific aims
This project will follow a twofold approach. First, the investigators will consider an "inter-patient" approach where independent and absolute Magnetic Resonance metrics for each limb will be related to disability. Second, the investigators will consider an "intra-patient" approach (i.e. comparing differences of Magnetic Resonance metric and of clinical score from the left and the right side in the same patient). For this purpose, progressive Multiple Sclerosis patients with asymmetric motor impairment will be studied. Confronting clinical and Magnetic Resonance Imaging metric value asymmetries indeed offers the unique opportunity to free oneself from many confounding factors such as genetics, age, duration of disease evolution, acquisition bias, etc. These two approaches will allow us to precisely study the impact of local factors such as Multiple Sclerosis lesions located on motor tracts on motor disability.
Methodology
The investigators propose an observational multicenter cross-sectional and prognostic study. This study will involve two French centers (Rennes, Marseille) and will include a total of 40 progressive Multiple Sclerosis patients with an asymmetrical motor deficit. Twenty sex and age matched controls will be needed to calibrate quantitative Magnetic Resonance imaging (magnetization transfer ratio). Encephalic and pan medullar structural and quantitative Magnetic Resonance images will be acquired at inclusion and clinical follow-up examinations will be performed at inclusion and 24 months. Detailed motor evaluation "per limb" will be performed, including the motor American Society Injury. Association sub-score and upper and lower limbs muscle strength measurements using a dynamometer.
- Being tested
- Magnetic Resonance Imaging, Neurological examination, Multiple Sclerosis Functional Composite, Physiotherapist examination
- Keywords
- motor disability, Magnetic Resonance Imaging
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingRadiation
Encephalic (about 30 minutes*)
- lesion location assessment: 3D FLAIR, 3DT1, 3DT2 (standard OFSEP protocol)
- lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1)
- tract location assessment: 30 directions diffusion imaging (standard OFSEP protocol)
- B0 and B1 mapping to correct for B0 and B1 inhomogeneities ● Spinal cord (about 50 minutes*)
- lesion location assessment: cervical and thoracic sagittal T2 TSE (0.7x0.7x2.5mm3), axial cervical MEDIC T2* (0.7x0.7x3mm3), axial thoracic T2 (0.5x0.5x3mm3)
- lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1, 0.7x0.7x3mm3) on the cervical cord and on the thoracic cord
- tract location assessment: performed from registration on atlas
- B0 and B1 mapping to correct for B0 and B1 inhomogeneities
Neurological examinationDiagnostic test
Global disability will be scored using the Expanded Disability Status Scale score
Multiple Sclerosis Functional CompositeDiagnostic test
- Walking disability will be scored using the 25-foot timed-walked test
- Arm disability will be scored using the nine-hole peg test
Physiotherapist examinationDiagnostic test
- American Society Injury. Association motor subscore for each limb
- The muscle strength using a dynamometer. Two muscle groups will be tested for the upper (elbow flexors and extensors) and lower limbs (hip flexors and ankle dorsiflexion).
- The Ashworth Scale and the Tardieu Scale to assess spasticity.
- 6 minutes walking test
- Fatigue Severity Scale
- MFIS : Modified Fatigue Impact Scale
| Study group | Role | What they receive |
|---|---|---|
| Progressive Multiple Sclerosis patients | Progressive Multiple Sclerosis patients Receives: Radiation: Magnetic Resonance Imaging; Diagnostic Test: Neurological examination; Diagnostic Test: Multiple Sclerosis Functional Composite; Diagnostic Test: Physiotherapist examination | |
| Healthy Volunteers | Healthy Volunteers Receives: Radiation: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
link between focal and diffuse damage in motor tract
link between focal and diffuse damage in motor tract per side and it functional consequences per limb assessed clinically at baseline
Measured: Baseline
Secondary outcomes (4)
Link between the asymmetry of functional motor impairment and the asymmetry of structural damage on the motor pathways
To study the link between the asymmetry of functional motor impairment and the asymmetry of structural damage on the motor pathways (intra-patient assessment).
Measured: Baseline
prognostic value of motor tract focal and diffuse damage on clinical scores variations
To study the prognostic value of motor tract focal and diffuse damage on clinical scores variations at 2 years
Measured: 24 months
link between fatigability, fatigue and analytical disorders
To explore fatigability during the 6-minute instrumented walking test (evolution of spatio-temporal parameters: walking speed, step length, cadence; feeling of fatigue) and to study the link between fatigability, fatigue and analytical disorders (strength, spasticity)
Measured: 24 months
link between fatigue and fatigability and the focal and diffuse impairment of the motor pathways
To study the link between fatigue and fatigability and the focal and diffuse impairment of the motor pathways.
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 posted8 Jun 2021
- Study start3 Nov 2021
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Primary ProgressiveStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Kerbrat, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918225
- Sponsor's protocol ID
- 35RC20_9751_MAP-MS
- Acronym
- MAP-MS
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2021
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Asymmetry in Progressive Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04918225
- Acronym / sponsor ID
- MAP-MS / 35RC20_9751_MAP-MS
- Keywords
- motor disability, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 8 Jun 2021 (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.
Project Rational
A better understanding of the causes of physical disability is an important unmet need in progressive Multiple Sclerosis patients. Progressive Multiple Sclerosis patients most often present a worsening pyramidal syndrome of lower and, to a lesser extent, upper limbs (Lublin et al., 2014) suggesting a strong corticospinal tract involvement. The systematic high resolution Magnetic Resonance Imaging exploration of lesions location and severity, as well as extra-lesional tissue, on pan-medullar and encephalic motor tracts offers the opportunity to better understand the pathological mechanism associated with motor impairment.
Scientific aims
This project will follow a twofold approach. First, the investigators will consider an "inter-patient" approach where independent and absolute Magnetic Resonance metrics for each limb will be related to disability. Second, the investigators will consider an "intra-patient" approach (i.e. comparing differences of Magnetic Resonance metric and of clinical score from the left and the right side in the same patient). For this purpose, progressive Multiple Sclerosis patients with asymmetric motor impairment will be studied. Confronting clinical and Magnetic Resonance Imaging metric value asymmetries indeed offers the unique opportunity to free oneself from many confounding factors such as genetics, age, duration of disease evolution, acquisition bias, etc. These two approaches will allow us to precisely study the impact of local factors such as Multiple Sclerosis lesions located on motor tracts on motor disability.
Methodology
The investigators propose an observational multicenter cross-sectional and prognostic study. This study will involve two French centers (Rennes, Marseille) and will include a total of 40 progressive Multiple Sclerosis patients with an asymmetrical motor deficit. Twenty sex and age matched controls will be needed to calibrate quantitative Magnetic Resonance imaging (magnetization transfer ratio). Encephalic and pan medullar structural and quantitative Magnetic Resonance images will be acquired at inclusion and clinical follow-up examinations will be performed at inclusion and 24 months. Detailed motor evaluation "per limb" will be performed, including the motor American Society Injury. Association sub-score and upper and lower limbs muscle strength measurements using a dynamometer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Multiple Sclerosis patients | – | Radiation: Magnetic Resonance Imaging, Diagnostic Test: Neurological examination, Diagnostic Test: Multiple Sclerosis Functional Composite, Diagnostic Test: Physiotherapist examinationProgressive Multiple Sclerosis patients |
| Healthy Volunteers | – | Radiation: Magnetic Resonance ImagingHealthy Volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient population will consist of progressive Multiple Sclerosis patients (both Primary Progressive Multiple Sclerosis and Secondary Progressive Multiple Sclerosis), a population for whom a better understanding of the causes of disability is an unmet need.
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 |
|---|---|---|
| Magnetic Resonance ImagingEncephalic (about 30 minutes*) * lesion location assessment: 3D FLAIR, 3DT1, 3DT2 (standard OFSEP protocol) * lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1) * tract location assessment: 30 directions diffusion imaging (standard OFSEP protocol) * B0 and B1 mapping to correct for B0 and B1 inhomogeneities ● Spinal cord (about 50 minutes*) * lesion location assessment: cervical and thoracic sagittal T2 TSE (0.7x0.7x2.5mm3), axial cervical MEDIC T2* (0.7x0.7x3mm3), axial thoracic T2 (0.5x0.5x3mm3) * lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1, 0.7x0.7x3mm3) on the cervical cord and on the thoracic cord * tract location assessment: performed from registration on atlas * B0 and B1 mapping to correct for B0 and B1 inhomogeneities | Radiation | Healthy Volunteers, Progressive Multiple Sclerosis patients |
| Neurological examinationGlobal disability will be scored using the Expanded Disability Status Scale score | Diagnostic test | Progressive Multiple Sclerosis patients |
| Multiple Sclerosis Functional Composite* Walking disability will be scored using the 25-foot timed-walked test * Arm disability will be scored using the nine-hole peg test | Diagnostic test | Progressive Multiple Sclerosis patients |
| Physiotherapist examination* American Society Injury. Association motor subscore for each limb * The muscle strength using a dynamometer. Two muscle groups will be tested for the upper (elbow flexors and extensors) and lower limbs (hip flexors and ankle dorsiflexion). * The Ashworth Scale and the Tardieu Scale to assess spasticity. * 6 minutes walking test * Fatigue Severity Scale * MFIS : Modified Fatigue Impact Scale | Diagnostic test | Progressive Multiple Sclerosis patients |
Primary outcome
link between focal and diffuse damage in motor tract
Time frame: Baseline
link between focal and diffuse damage in motor tract per side and it functional consequences per limb assessed clinically at baseline
4 secondary outcomes
Link between the asymmetry of functional motor impairment and the asymmetry of structural damage on the motor pathways
Time frame: Baseline
prognostic value of motor tract focal and diffuse damage on clinical scores variations
Time frame: 24 months
link between fatigability, fatigue and analytical disorders
Time frame: 24 months
link between fatigue and fatigability and the focal and diffuse impairment of the motor pathways
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 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis, Primary Progressive
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
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.
Anne Kerbrat, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Primary Progressive and Multiple Sclerosis, Secondary Progressive, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
link between focal and diffuse damage in motor tract (time frame: Baseline). 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 19 Mar 2026.