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NCT Number: NCT03841903

Spinal Cord Analysis in Multiple Sclerosis

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Neurology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal cord MRI

Diagnostic Test

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 outcomes

  1. Change in SC atrophy assessed by MRI

    Time frame: 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 outcomes

  1. Change in Timed 25-foot walk test (T25-FW)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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