The effect of natalizumab treatment on functional adaptation in multiple sclerosis (MS)

The effect of natalizumab treatment on functional adaptation in multiple sclerosis (MS) - Natalizumab and functional adaptation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40114

Enrollment

Registered

2010-05-31

Start date

2010-06-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple Sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Functional connectivity changes, as measured by fMRI, will be used as an outcome measure for studying the effect of pharmacotherapeutical treatment.	—

Secondary

Measure	Time frame
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?	—

Measure

Time frame

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?

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Countries

Netherlands

Outcome results