MS Multiple Sclerosis
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following eligibility criteria at baseline: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations; 2. All participants should be 18-65 years of age; 3. Sufficient Dutch proficiency to be able to comprehend and to perform the neuropsychological examination; 4. All participants need to meet the safety criteria to undergo an MRI examination; For the patients specifically: 5. Only patients that are recently (between 6 up to 12 months) diagnosed with clinically definite MS according to the 2017 revision of the McDonald MS criteria will be included (a range of one month before and after this window was applied; thus 5-13 months); 6. Only patients with (active) relapsing-remitting disease course will be included; 7. All types of disease modifying treatment for MS are allowed.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from study entry if any of the following exclusion criteria exist at baseline: 1. Unable or unwilling to provide informed consent; 2. Presence or history of alcohol or drug abuse; 3. Presence or history of psychiatric or neurological disease of the CNS (for patients: neurological disease other than MS) that is expected to affect any of the outcome measures (will be discussed with the principal investigator and neurologist); 4. Presence of contra-indications for MRI; 5. Participation in other (scientific) studies using cognitive or physical training programs (interventions other than standard care) at baseline to avoid noise. For the patient groups specifically: 6. Patients with disease categorized as clinically isolated syndrome, primary progressive, secondary progressive or progressive relapsing; 7. Relapses or steroid treatment less than four weeks prior to the visits. Visits of included patients experiencing a relapse will be postponed if possible; 8. Patients undergoing a cognitive relapse. Visits of included patients experiencing a cognitive relapse will be postponed if possible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in structural MRI (i.e. atrophy and (grey matter) lesions) will serve as primary outcome measures, such as atrophy in the cortex and deep grey matter, changes in white matter damage in specific tracts and white matter and cortical lesions. Next, changes in functional brain measures will be included, measuring for instance functional connectivity, eigenvector centrality mapping and functional brain adaptation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cognitive performance (as measured with the neuropsychological examination) and clinical performance (as measured with the neurological examination) will serve as secundary parameters. Additionally, changes on questionnaires (e.g. arm and walk function, fatigue, anxiety and depression, subjective cognitive perfor-mance, coping style, mastery, stress, work participation and quality of life) will be included. Molecular brain changes will also be investigated, addressing for example changes in GABA/glutamate and serum biomarkers NfL and GFAP. | — |
Countries
Netherlands
Outcome results
None listed