Status:
RECRUITING
Motor Asymmetry in Progressive Multiple Sclerosis Patients
Lead Sponsor:
Rennes University Hospital
Conditions:
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive
Eligibility:
All Genders
18-60 years
Brief 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 ...
Eligibility Criteria
Inclusion
- \- Inclusion Criteria:
- 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.
- 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:
- 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 / 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.
Exclusion
Key Trial Info
Start Date :
November 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04918225
Start Date
November 3 2021
End Date
May 1 2026
Last Update
April 26 2023
Active Locations (2)
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1
Hôpital de la Timone, AP-HM
Marseille, France, 13385
2
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033