The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional connectivity changes, as measured by fMRI, will be used as an
outcome measure for studying the effect of pharmacotherapeutical treatment.
Secondary outcome
Progression of disability will measured through change in Extended Disability
Status Schale (EDSS) and Multiple Sclerosis Functional Composite (MSFC).
Cognitive decline as measured by change in Brief Repeatable Battery -
Neuropsychological tests (BRB-N) scores.
Subproject fatigue
Almost all patients with MS experience symptoms of (severe) fatigue. This can
be either cognitive fatigue or physical fatigue. Therefore we also want to
answer the following research question: Is physical fatigue related to
cognitive fatigue? And what is the role of coping style with regard to fatigue
(as measured with the different questionnaires).
For the two additional time points, we also would like to address the following
research question: Does natalizumab enhance structural damage over time?
Background summary
Cognitive impairment in MS has not been as extensively investigated as physical
disability in MS, although cognitive impairment is reported in 40% to 65% of MS
patients at both the earlier and later stages of the disease. Patients with MS
that are cognitively impaired experience several problems in daily living.
Natalizumab has an anti-inflammatory effect and significantly reduces relapse
rate, disability progression and lesion development in Relapsing Remitting
Multiple Sclerosis (RRMS) patients. In response to CNS (Central Nervous System)
damage - including inflammation - the brain has to functionally adapt. We
hypothesize that the anti-inflammatory effect of natalizumab will amplify the
effect on functional adaptation. This enhanced functional adaptation will have
a positive outcome on disability, progression and cognitive decline.
Study objective
The main objective of the study is to investigate whether the strong clinical
effects of natalizumab in RRMS can be explained by enhanced functional
adaptation mechanisms of the brain and whether enhanced functional
reorganisation is sustained over time. Does natalizumab affect functional
connectivity as measured by resting-state functional Magnetic Resonance Imaging
(fMRI)? Does enhanced functional adaptation, induced by natalizumab treatment,
affect physical disability and cognitive decline?
Study design
The study is a prospective, single-centre, observational, longitudinal
patient-control study assessing the effect of natalizumab on functional
adaptation in RRMS patients.
Study burden and risks
For the two additional timepoints:
For the natalizumab patient group, at 24 months and 48 months visits the fMRI,
MTR and BRB-N are extra in addition to their annual medical monitoring. The SDM
group has no frequent medical monitoring, consequently, similar to the first
visits, MRI, fMRI, MTR BRB-N, EDSS and MSFC will be conducted at the 24 and 48
month visits.
The risk of f(MRI) is negligible, especially after screening for risk-factors
prior to the (f)MRI.
Van Der Boechorststraat 7
Amsterdam 1007 MB
NL
Van Der Boechorststraat 7
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
Age 18-65
RRMS
Meet safety criteria for MRI
Group 1: starting or recently started natalizumab
Group 2: using standard treatment
Exclusion criteria
MS other than RRMS
Presence or history of psychiatric disease
Presence or history of neurologic disease
Presence or history of alcohol or drug abuse
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2010-020765-24-NL |
| CCMO | NL32274.029.10 |