Understanding motor disability in progressive Multiple Sclerosis patients

Motor Asymmetry in Progressive Multiple Sclerosis Patients

This study is trying to understand what causes physical disability in people with progressive Multiple Sclerosis by looking at brain scans to see how lesions affect movement.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Rennes University Hospital (Academic / other)
• Locations: 2 sites (Marseille and 1 other locations)
• Trial ID: NCT04918225 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the causes of physical disability in patients with Primary and Secondary Progressive Multiple Sclerosis. By utilizing high-resolution Magnetic Resonance Imaging, the study will assess the location and severity of lesions in the motor tracts of the brain and spinal cord. It will employ both inter-patient and intra-patient approaches to correlate MRI metrics with motor deficits. The goal is to gain insights into the pathological mechanisms that contribute to motor impairment in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 60 with Primary or Secondary Progressive Multiple Sclerosis and specific asymmetric motor deficits.

Not a fit: Patients with other forms of Multiple Sclerosis or those with significant inflammatory activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of motor disabilities in progressive Multiple Sclerosis patients.

How similar studies have performed: While similar studies have explored motor deficits in Multiple Sclerosis, this specific approach using high-resolution MRI metrics is relatively novel.

Eligibility criteria

1. - 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.
2. - 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.

Where this trial is running

Marseille and 1 other locations

• Hôpital de la Timone, AP-HM — Marseille, France (Not_yet_recruiting)
• CHU de Rennes - Hôpital Pontchaillou — Rennes, France (Recruiting)

Study contacts

• Principal investigator: Anne Kerbrat, MD — CHU Rennes
• Study coordinator: Anne Kerbrat, MD

Conditions Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive; motor disability, Magnetic Resonance Imaging