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

Recruiting

Conditions: Relapsing-Remitting Multiple Sclerosis

Registration Number: NL-OMON21490

Lead Sponsor: Biogen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1) ability to understand purpose of the study and provide informed consent
2) 18-65 years old
3) need to meet safety criteria to undergo MRI-scan
4) sufficient visual acuity and motor skills to perfom fMRI task
5) patients with RRMS
6) if using other drugs influencing CNS, they need to be stable on this medication at least for 6 months.

Exclusion Criteria

1) unable/unwilling to provide informed consent
2) presence/history psychiatric or neurological disease (other than MS for patient group) that may affect outcome measures
3) contra-indication for MRI
4) history/presence alcohol/drug abuse
5) participation in other studies using cognitive or physical training programs to avoid noise.

For patient groups specifically:
6) PPMS or SPMS
7) relapse and steroid treatment 4 weeks < examination

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to investigate changes in white matter structural integrity in patients with relapsing remitting multiple sclerosis (MS) after a different treatment duration with Tecfidera (i.e 6 months, 12 months, 18 months, and 30 months).The primary endpoint that relates to this objective is change from baseline (or previous time point) in diffusion tensor imaging measures (fractional anisotropy and mean diffusivity).

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are the effects of Tecfidera (over time) on: structural brain damage, functional connectivity, brain activation patterns during fMRI task, physical disability and cognitive decline, brain metabolite concentrations.