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Improving Myelin Imaging in Multiple Sclerosis

Improving Myelin Imaging in Multiple Sclerosis - IMPROMYND

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57553
Enrollment
127
Registered
2024-06-19
Start date
2025-12-18
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Multiple Sclerosis

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: For patients: - known clinical diagnosis of relapsing remitting MS (RRMS) according to the 2017 McDonald criteria - 18-60 years - Extended Disability Status Scale (EDSS) 0 - 5.5 at screening - High-efficacy medication (natalizumab, ocrelizumab, ofatumumab, rituximab, alemtuzumab, cladribine) and intermediate-efficacy medication (dimethyl fumarate, diroximelfumarate, fingolimod, ozanimod, ponesimod) - Maximal disease duration of 10 years and a minimum of 3 months after treatment regime change For healthy controls: age between 18-60 years

Exclusion criteria

Exclusion criteria: • Patients on low-efficacy medication (interferon ß, peginterferon, glatiramer  acetate, teriflunomide); • Patients with a disease duration of more than 10 years or a treatment regime  change within the last 3 months; • Contradictions for MRI scanning (e.g. metal implants, cardiac pacemaker,  claustrophobia); • Absence of written informed consent;  • Patients who have other underlying brain related diseases; and • History of head/brain surgery.

Design outcomes

Primary

MeasureTime frame
Progression in terms of cognitive and motoric tests and lesions will be established using MWI and prognostic markers in terms of baseline myelin content will be investigated.

Secondary

MeasureTime frame
To explore how findings obtained with MWI relate to those observed with the other MRI techniques in the scan protocol (e.g. ihMTR, SWI, T1- and/or T2-weighted and FLAIR method). To investigate associations between MWI-derived outcome measures and motor, as well as cognitive performance, as assessed by standardized tests.To study the cognitive and motor functions with the standardized tests in terms of progression of RRMS comparing it to the accompanying deterioration/stability in clinical measures (e.g. memory, attention, executive functioning, pain, spasms, etc.), based on subjective complaints of the patients.To test for the (amount of) presence of blood markers and possible correlations with the imaging of the central neural system or cognitive and motor tests.To compare the treatment strategy with myelin content and clinical outcome to study the effects of different medications.

Countries

Netherlands

Contacts

Public ContactJ.F.A. Jansen

Universiteit Maastricht

jacobus.jansen@mumc.nl043 387 4908

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)