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Spinal Cord Analysis in Multiple Sclerosis

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03841903
Collaborator
(none)
79
Enrollment
1
Location
32.8
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: spinal cord MRI

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 Design

Study Type:
Observational
Actual Enrollment :
79 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Mar 24, 2020
Actual Study Completion Date :
Mar 24, 2020

Arms and Interventions

Arm Intervention/Treatment
relapsing-remitting MS undergoing spinal cord MRI

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)
secondary progressive MS undergoing spinal cord MRI

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)
primary progressive MS undergoing spinal cord MRI

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)
healthy control (HC) undergoing spinal cord MRI

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dep. of Neurology, University Hospital Basel Basel Switzerland 4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Ludwig Kappos, Prof. Dr. MD, Department of Neurology University Hospital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03841903
Other Study ID Numbers:
  • 2016-01461; me16Kappos2
First Posted:
Feb 15, 2019
Last Update Posted:
Mar 31, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
Spinal cord
Spinal cord atrophy
Cerebrospinal Fluid
Swiss Multiple Sclerosis Cohort
Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis

Study Results

No Results Posted as of Mar 31, 2020