NCT04918225

Motor Asymmetry in Progressive Multiple Sclerosis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
RADIATION	Magnetic Resonance Imaging	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
DIAGNOSTIC_TEST	Neurological examination	Global disability will be scored using the Expanded Disability Status Scale score
DIAGNOSTIC_TEST	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	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

Timeline

• Start date: 2021-11-03
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2021-06-08
• Last updated: 2026-03-19

Locations

1 site across 1 country: France