No registrations found.
ID
Source
Brief title
Health condition
Relapsing-Remitting Multiple Sclerosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
This clinical observational, single center study will be performed at the VU University Medical Center in Amsterdam. The study population consists of 60 RRMS patients (n=30 starting on Tecfidera, n=30 using Tecfidera for ~1 year) and 30 healthy controls. Neuropsychological and neurogical assessments as well as questionnaires and a (f)MRI-scan will be performed at baseline, after 6 months and 18 months, to longitudinally look at the short- and long time effects of Tecfidera treatment on the brain and cognition in MS.
Study objective
We expect to see improved white matter integrity (i.e. estimated by increased fractional anisotropy, decreased mean diffusivity) in response to Tecfidera treatment. As a result physical functioning might improve, cognitive functioning will be stable (in cognitively intact patients) /improve (in cognitively impaired patients). Stronger effects are expected after a longer duration of treatment.
Study design
T0: first measurement, T1: at 6 months, T2: at 18 months
Intervention
N/A
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7944 |
| Other | METC VUMC : METC 2017.469 / ABR: NL63236.029.17 |