Effects of dimethyl fumarate (Tecfidera) on white matter integrity and functional brain adaptation and cognition in Multiple Sclerosis

Recruiting

Conditions: MS
Multiple sclerosis
10012303

Registration Number: NL-OMON55481

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

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

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.
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Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint that relates to the objective is change in diffusion<br /><br>tensor imaging measures (fractional anisotropy and mean diffusivity).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The additional objectives and endpoints of this study in this study population<br /><br>are as follows:<br /><br>- Does Tecfidera limit structural brain damage over time? Endpoints: brain<br /><br>atrophy, gray and white matter lesions;<br /><br>- How does treatment with Tecfidera effect functional connectivity as measured<br /><br>by resting-state functional MRI? Endpoint: functional connectivity changes;<br /><br>- How does Tecfidera influence brain activation patterns and task performance<br /><br>during an information processing speed task (task-related fMRI)? Endpoints:<br /><br>improved processing speed performance, altered activation patterns;<br /><br>- How does Tecfidera influence physical disability and cognitive decline?<br /><br>Endpoints: change on EDSS, change on cognitive tests;<br /><br>- Exploratory endpoint: How does Tecfidera influence concentrations of brain<br /><br>metabolites? Endpoint: change on MR spectroscopy.</p><br>