Multiple SclerosisNCT03841903
Spinal Cord Analysis in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- spinal cord MRI
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 24 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Diagnosis of multiple sclerosis
- Steroid free period: > 4 weeks
- healthy controls without any history of severe neurological, internistic or psychiatric disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Neurology, University Hospital Basel
Basel, 4031
About this study
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)
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- spinal cord MRI
- Keywords
- Spinal cord, Spinal cord atrophy, Cerebrospinal Fluid, Swiss Multiple Sclerosis Cohort
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord MRIDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| relapsing-remitting MS undergoing spinal cord MRI | Not described Receives: Diagnostic Test: spinal cord MRI | |
| secondary progressive MS undergoing spinal cord MRI | Not described Receives: Diagnostic Test: spinal cord MRI | |
| primary progressive MS undergoing spinal cord MRI | Not described Receives: Diagnostic Test: spinal cord MRI | |
| healthy control (HC) undergoing spinal cord MRI | Not described Receives: Diagnostic Test: spinal cord MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and after 1 year
Secondary outcomes (2)
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.
Measured: at baseline and after 1 year and after 5 years
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.
Measured: at baseline and after 1 year and after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jul 2017
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludwig Kappos, Prof. Dr. MD, Principal investigator, Department of Neurology University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841903
- Sponsor's protocol ID
- 2016-01461; me16Kappos2
- Other IDs
- 2016
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03841903
- Acronym / sponsor ID
- 2016-01461; me16Kappos2
- Conditions
- Multiple Sclerosis
- Keywords
- Spinal cord, Spinal cord atrophy, Cerebrospinal Fluid, Swiss Multiple Sclerosis Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of multiple sclerosis
- Steroid free period: > 4 weeks
- healthy controls without any history of severe neurological, internistic or psychiatric disease
Key exclusion criteria (6 listed)
- History of severe (other) neurological, internistic or psychiatric disease
- MRI related exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal cord MRIhigh-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) | Diagnostic test | 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 |
Primary outcome
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.
2 secondary outcomes
Change in Timed 25-foot walk test (T25-FW)
Time frame: at baseline and after 1 year and after 5 years
Change in Multiple Sclerosis Walking Scale-12 (MSWS-12) Questionnaire
Time frame: at baseline and after 1 year and after 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludwig Kappos, Prof. Dr. MD principal investigator
Department of Neurology University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SC atrophy assessed by MRI (time frame: at baseline and after 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.