Spinal Cord Analysis in Multiple Sclerosis

NCT03841903 | Completed

• 1 other identifier: 2016-01461; me16Kappos2
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Spinal cord; Spinal cord atrophy; Cerebrospinal Fluid; Swiss Multiple Sclerosis Cohort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  at baseline and after 1 year and after 5 years

• Change in Multiple Sclerosis Walking Scale-12 (MSWS-12) Questionnaire

  at baseline and after 1 year and after 5 years

Study Arms (4)

relapsing-remitting MS undergoing spinal cord MRI

Diagnostic Test: spinal cord MRI

secondary progressive MS undergoing spinal cord MRI

Diagnostic Test: spinal cord MRI

primary progressive MS undergoing spinal cord MRI

Diagnostic Test: spinal cord MRI

healthy control (HC) undergoing spinal cord MRI

Diagnostic Test: spinal cord MRI

Interventions

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)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The recruitment of MS patients will take place within the ongoing SMSC study at the MS Clinic of the Department of Neurology (Neurologische Klinik und Poliklinik), University Hospital Basel (Universitätsspital Basel). Healthy subjects will be recruited by public announcements on the University Hospital's and the University's notice board.

You may qualify if:

• Diagnosis of multiple sclerosis
• Steroid free period: \> 4 weeks
• healthy controls without any history of severe neurological, internistic or psychiatric disease

You may not qualify if:

• History of severe (other) neurological, internistic or psychiatric disease
• Paramagnetic and/or superparamagnetic foreign objects in the body
• Pacemaker
• Claustrophobia
• Pregnancy, lactation

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Dep. of Neurology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ludwig Kappos, Prof. Dr. MD

  Department of Neurology University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: July 1, 2017
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

CH (1)