MS Multiple sclerosis
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, candidates 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. All participants need to meet the safety criteria to undergo an MRI examination; 4. All participants should have sufficient visual acuity and motor skills to perform the fMRI task;For the patient groups specifically: 5. Only patients with (active) RRMS will be included; 6. Patients using other drugs influencing the CNS (such as anti-depressants, stimulants, anti-epileptica etc) should be stable on this medication using it for at least 6 months;
Exclusion criteria
Exclusion criteria: Candidates 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 psychiatric or neurological disease (for patients: neurological disease other than MS) that is expected to affect outcome measures (will be discussed with the principal investigator and neurologist); 3. Presence of contra-indications for MRI; 4. History or presence of alcohol or drug abuse; 5. Participation in other (scientific) studies using cognitive or physical training interventionsFor the patient groups specifically: 6. Patients with disease categorized as primary progressive, secondary progressive or progressive relapsing; 7. Patients that had a relapse and steroid treatment within the four weeks prior to examination. it for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint that relates to the objective is change in diffusion tensor imaging measures (fractional anisotropy and mean diffusivity). | — |
Secondary
| Measure | Time frame |
|---|---|
| The additional objectives and endpoints of this study in this study population are as follows: - Does Tecfidera limit structural brain damage over time? Endpoints: brain atrophy, gray and white matter lesions; - How does treatment with Tecfidera effect functional connectivity as measured by resting-state functional MRI? Endpoint: functional connectivity changes; - How does Tecfidera influence brain activation patterns and task performance during an information processing speed task (task-related fMRI)? Endpoints: improved processing speed performance, altered activation patterns; - How does Tecfidera influence physical disability and cognitive decline? Endpoints: change on EDSS, change on cognitive tests; - Exploratory endpoint: How does Tecfidera influence concentrations of brain metabolites? Endpoint: change on MR spectroscopy. | — |
Countries
Netherlands
Outcome results
None listed