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

Recruiting

• Conditions: Relapsing-Remitting Multiple Sclerosis

• Registration Number: NL-OMON28418
• Lead Sponsor: Bristol Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

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 (up to 12 months) diagnosed with clinically definite MS according to the 2017 revision of the McDonald MS criteria will be included;
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

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 non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in structural and functional MRI 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 Outcome Measures

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