The effect of natalizumab treatment on functional adaptation in multiple sclerosis (MS)
Completed
- Conditions
- 10012303MSMultiple Sclerosis10003816
- Registration Number
- NL-OMON40114
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Functional connectivity changes, as measured by fMRI, will be used as an<br /><br>outcome measure for studying the effect of pharmacotherapeutical treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Progression of disability will measured through change in Extended Disability<br /><br>Status Schale (EDSS) and Multiple Sclerosis Functional Composite (MSFC).<br /><br>Cognitive decline as measured by change in Brief Repeatable Battery -<br /><br>Neuropsychological tests (BRB-N) scores.<br /><br><br /><br>Subproject fatigue<br /><br>Almost all patients with MS experience symptoms of (severe) fatigue. This can<br /><br>be either cognitive fatigue or physical fatigue. Therefore we also want to<br /><br>answer the following research question: Is physical fatigue related to<br /><br>cognitive fatigue? And what is the role of coping style with regard to fatigue<br /><br>(as measured with the different questionnaires).<br /><br><br /><br>For the two additional time points, we also would like to address the following<br /><br>research question: Does natalizumab enhance structural damage over time? </p><br>