Spinal Cord Analysis in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Diagnostic Test: spinal cord MRI

• Registration Number: NCT03841903
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Status Verified: 2020-03
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-24
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
secondary progressive MS undergoing spinal cord MRI	spinal cord MRI	-
healthy control (HC) undergoing spinal cord MRI	spinal cord MRI	-
relapsing-remitting MS undergoing spinal cord MRI	spinal cord MRI	-
primary progressive MS undergoing spinal cord MRI	spinal cord MRI	-

Primary Outcome Measures

Name	Time	Method
Change in SC atrophy assessed by MRI	at baseline and after 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Change in Timed 25-foot walk test (T25-FW)	at baseline and after 1 year and after 5 years	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.
Change in Multiple Sclerosis Walking Scale-12 (MSWS-12) Questionnaire	at baseline and after 1 year and after 5 years	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.

Trial Locations

Locations (1)

Dep. of Neurology, University Hospital Basel; 🇨🇭 Basel, Switzerland