The importance of early brain changes in patients with MS with regard to cognitive and physical outcome

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in structural MRI (i.e. atrophy and (grey matter) lesions) will serve<br /><br>as primary outcome measures, such as atrophy in the cortex and deep grey<br /><br>matter, changes in white matter damage in specific tracts and white matter and<br /><br>cortical lesions.<br /><br>Next, changes in functional brain measures will be included, measuring for<br /><br>instance functional connectivity, eigenvector centrality mapping and functional<br /><br>brain adaptation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in cognitive performance (as measured with the neuropsychological<br /><br>examination) and clinical performance (as measured with the neurological<br /><br>examination) will serve as secundary parameters. Additionally, changes on<br /><br>questionnaires (e.g. arm and walk function, fatigue, anxiety and depression,<br /><br>subjective cognitive perfor-mance, coping style, mastery, stress, work<br /><br>participation and quality of life) will be included.<br /><br>Molecular brain changes will also be investigated, addressing for example<br /><br>changes in GABA/glutamate and serum biomarkers NfL and GFAP. </p><br>