The effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS)

Completed

Conditions: MS
multiple sclerosis
10003816
10012303

Registration Number: NL-OMON35491

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

age 18-65
RRMS or relapsing SPMS
Meet safety criteria for MRI
Group 1: Subjects affected by RRMS starting or recently started with Interferon beta-1a treatment
Group 2: Subjects affected by relapsing SPMS on interferon beta-1a treatment.
Group 3: Untreated Subjects affected by RRMS or relapsing SPMS
Group 4: Healthy controls

Exclusion Criteria

MS other than RRMS or relapsing SPMS
presence or history of psychiatric disease
presence or history of neurological disease
presence or history of alcohol or drug abuse
presence of contra-indications for MRI
presence of contra-indications for Rebif
Use of immunosupressive agents

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints: The mean change of each subject affected by RRMS or<br /><br>relapsing SPMS from baseline in functional connectivity (resting-state) fMRI at<br /><br>month 24. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints: Clinicial measures (progression of disability) will be<br /><br>measured through change in Extended Disability Status Scale (EDSS) and Multiple<br /><br>Sclerosis Functional Composite (MSFC). Clinical measures (progression of<br /><br>disease activity) as measured through the number of relapses and annualized<br /><br>relapse rate. Cognitive decline as measured by change in Brief Repeatable<br /><br>Battery * Neuropsychological tests (BRB-N) scores. Correlations fMRI and<br /><br>clinical/cognitive outcomes. And Requirement for treatment with corticosteroids<br /><br>due to relapses. </p><br>