An observational study in Multiple Sclerosis, sponsored by University Hospital, Basel, Switzerland. Recruiting at 8 sites in Switzerland. Per ClinicalTrials.gov, last updated 2025-04-14.
Sponsored by University Hospital, Basel, Switzerland · Observational
The Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are
The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data.
Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the:
Patients with a diagnosis of radiologically isolated syndrome (RIS), clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), neuromyelitis optica spectrum disorder (NMOSD) or Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)
Inclusion Criteria:
Inclusion criteria are crafted to identify a population of patients with MS, NMOSD or MOGAD particularly suitable for analysing disease evolution and associated factors, treatment dynamics, and the long-term safety and efficacy profile of disease-modifying drugs.
There are no specific Exclusion Criteria.
Assessment of Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) is measured using Neurostatus by certified neurologists
Time frame: Baseline and at each follow-up visit (every 6 or 12 months)
Assessment of the quality of life
To assess the quality of life, the following patient-reported outcomes are collected: * Multiple Sclerosis Quality of Life-54: A self-report questionnaire regarding quality of life with 36 generic (which corresponds to the 36 items of the Short-Form-36 questionnaire) and 18 MS-specific items. * EuroQoL-5D: A self-report questionnaire on generic quality of life, with one question for each of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a Visual Analog Scale regarding perceived health status, ranging from 0 (worst possible) to 100 (best possible). * Patient reported questionnaire: Includes questions regarding professional activity and changes, and hospitalization.
Time frame: Baseline and at least once a year
Collection of serum and plasma (and, optional) cerebrospinal fluid samples
Serum and plasma samples will be collected every 6 or 12 months for all participants during study visit. Cerebrospinal fluid samples are facultative and contribute only if the participant is undergoing a diagnostic lumbar puncture.
Time frame: Baseline and at each follow-up visit (every 6 or 12 months)
(Optional) Assessment of finger dexterity
To assess the finger dexterity, the 9-Hole Peg Test is performed. It evaluates manual dexterity by measuring the time it takes for the participant to move nine pegs from a box into nine holes on a board and back. The 9-Hole Peg Test is not mandatory and is performed at the discretion of the physician.
Time frame: Baseline and at each follow-up visit (every 6 or 12 months)
(Optional) Electrophysiological assessment
To measure the visual, sensory and motor conduction time in the CNS, evoked potential tests are performed. Evoked Potentials are not mandatory and is performed at the discretion of the physician.
Time frame: Baseline and at each follow-up visit (every 6 or 12 months)
(Optional) Laboratory tests
The following laboratory tests are not mandatory, but are routinely performed in patients with MS at the discretion of the physician: Anti-JCV antibody test * Anti-natalizumab antibody test * Lymphocyte count
Time frame: Baseline and at each follow-up visit (every 6 or 12 months)
(Optional) Magnetic resonance imaging
The MRI is optional. All MRIs are collected that are done in clinical routine and follow the SMSC MRI protocol.
Time frame: Baseline and at least once per year
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University Hospital, Basel, Switzerland