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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032184
Enrollment
300
Registered
2023-08-15
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

G35

Interventions

Group 1: Patients with initial diagnosis of relapsing or primary progressive MS (diagnosis according to the revised McDonald criteria) before initiation of immunomodulatory therapy. Group 2: Patients

Sponsors

Koordinierungsstelle Telemedizin Baden-Württemberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026