Spinal Cord Analysis in Multiple Sclerosis

Study Overview
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Brief Summary
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Research project in which patients with Multiple Sclerosis (MS) are examined clinically and with magnetic resonance imaging (MRI). To evaluate spinal cord (SC) grey and white matter changes (incl. lesions) using fast, high-resolution MRI sequences with high contrast between SC and cerebrospinal fluid (CSF) as well as high contrast within the SC (grey-white matter contrast).

Detailed Description
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The Swiss Multiple Sclerosis Cohort (SMSC-Study) aims to better evaluate specific Multiple Sclerosis (MS) phenotypes through the systematic and standardised documentation and acquisition of clinical course and paraclinical tests such as magnetic resonance imaging (MRI), blood and cerebrospinal fluid (CSF) specimens. Determination of the relative contribution of SC metrics (cervical cord volume, cervical grey matter (GM) cord volume, cervical white matter (WM) cord volume, SC lesion load) to disability in MS.

Official Title
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Structural Analysis of Spinal Cord Grey and White Matter Changes in Patients With Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC-study)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Diagnostic Test: spinal cord MRI


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosis of multiple sclerosis Steroid free period: > 4 weeks healthy controls without any history of severe neurological, internistic or psychiatric disease Exclusion Criteria for all participants: History of severe (other) neurological, internistic or psychiatric disease MRI related exclusion criteria: Paramagnetic and/or superparamagnetic foreign objects in the body Pacemaker Claustrophobia Pregnancy, lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| relapsing-remitting MS undergoing spinal cord MRI<br> | Diagnostic Test: spinal cord MRI<br>* high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)<br>|
| secondary progressive MS undergoing spinal cord MRI<br> | Diagnostic Test: spinal cord MRI<br>* high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)<br>|
| primary progressive MS undergoing spinal cord MRI<br> | Diagnostic Test: spinal cord MRI<br>* high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)<br>|
| healthy control (HC) undergoing spinal cord MRI<br> | Diagnostic Test: spinal cord MRI<br>* high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SC atrophy assessed by MRI | Determination of the degree of SC grey and white matter atrophy in MS patients with relapsing versus progressive disease courses in comparison to matched HC. Measurement tool is a structural MRI of the brain and spinal cord at 3 Tesla. Assessment will last approx. 90 minutes. | at baseline and after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed 25-foot walk test (T25-FW) | Quantitative mobility and leg function performance test ( in MS patients) based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. | at baseline and after 1 year and after 5 years | 
| Change in Multiple Sclerosis Walking Scale-12 (MSWS-12) Questionnaire | Self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. | at baseline and after 1 year and after 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord, Spinal cord atrophy, Cerebrospinal Fluid, Swiss Multiple Sclerosis Cohort