Spinal Cord Analysis in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841903
• Other study ID #: 2016-01461; me16Kappos2
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: March 24, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 24, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

1. Paramagnetic and/or superparamagnetic foreign objects in the body

2. Pacemaker

3. Claustrophobia

4. Pregnancy, lactation

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• spinal cord MRI
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)

Locations

Country	Name	City	State
Switzerland	Dep. of Neurology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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