- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918225
Motor Asymmetry in Progressive Multiple Sclerosis Patients (MAP-MS)
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 Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13385
- Not yet recruiting
- Hôpital de la Timone, AP-HM
-
Rennes, France, 35033
- Recruiting
- CHU de Rennes - Hôpital Pontchaillou
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteers
|
Encephalic (about 30 minutes*)
|
Progressive Multiple Sclerosis patients
|
Encephalic (about 30 minutes*)
Global disability will be scored using the Expanded Disability Status Scale score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Link between the asymmetry of functional motor impairment and the asymmetry of structural damage on the motor pathways
Time Frame: Baseline
|
To study the link between the asymmetry of functional motor impairment and the asymmetry of structural damage on the motor pathways (intra-patient assessment).
|
Baseline
|
prognostic value of motor tract focal and diffuse damage on clinical scores variations
Time Frame: 24 months
|
To study the prognostic value of motor tract focal and diffuse damage on clinical scores variations at 2 years
|
24 months
|
link between fatigability, fatigue and analytical disorders
Time Frame: 24 months
|
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)
|
24 months
|
link between fatigue and fatigability and the focal and diffuse impairment of the motor pathways
Time Frame: 24 months
|
To study the link between fatigue and fatigability and the focal and diffuse impairment of the motor pathways.
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC20_9751_MAP-MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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