Study to Predict Inflammation and Neurodegeneration in Primary Progressive Multiple Sclerosis

Recruiting

Conditions: PPMS
Primary Progressive Multiple Sclerosis
10012303

Registration Number: NL-OMON49540

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

- Aged 18 years or older
- Diagnosis:
fulfills the 2017 McDonald criteria for PPMS
OR:
Strong clinical suspicion of PPMS that has not (yet) fulfilled the 2017
McDonald criteria (e.g. symptoms have not yet lasted a full year, and/or
dissemination in time and place have not yet been proven), but in which other
possible diagnoses have been excluded
- Patients have to be able to give informed consent.

Exclusion Criteria

Severe comorbidity with a life expectancy of 6 months or less.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters is the division of PPMS-patients into a PPi- and<br /><br>PPn- subgroup, as determined by an expertpanel of three MS-neurologists and<br /><br>based upon known clinical and radiological features of inflammation in MS as<br /><br>measured during the years of follow-up. Different other radiological and<br /><br>biological markers, measured early in the disease course, will be analyzed for<br /><br>their predictive value for this outcome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Several radiological and biological markers will also be analyzed for their<br /><br>prognostic value, for which we will use several measures of disease severity as<br /><br>outcome: the EDSS, (expanded disability scale), the T25FW (Timed 25 Foot Walk)<br /><br>and the SDMT (symbol digit modalities test). </p><br>