Multivariate prediction of disease course and progression in multiple sclerosis using imaging, microbiome, and genetic, immunological, and neuropsychological parameters: a multicenter prospective cohort study

Recruiting

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00032184
• Lead Sponsor: Koordinierungsstelle Telemedizin Baden-Württemberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Relapsing or primary progressive multiple sclerosis confirmed according to the revised McDonald criteria.
- Initial diagnosis or presentation for evaluation of a change in therapy

Exclusion Criteria

- lack of informed consent
- concomitant diseases that prevent routine MRI examinations and regular clinical follow-up examinations (implanted devices, claustrophobia, severe psychiatric diseases)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of disease progression in patients with relapsing-remitting MS using clinical, neuropsychological and MR morphological data.

Secondary Outcome Measures

Name	Time	Method
In parallel, optional acquisition of genetic and immunological parameters, gut microbiome, and high-throughput metagenomics analysis to correlate with disease progression and identify/estimate individual risk profiles.