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…
ID
Bron
Verkorte titel
Aandoening
Relapsing-Remitting Multiple Sclerosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
T0: first measurement, T1: at 6 months, T2: at 18 months
Onderzoeksproduct en/of interventie
N/A
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7944 |
| Ander register | METC VUMC : METC 2017.469 / ABR: NL63236.029.17 |