Comparing the 2024 and 2017 McDonald rules for diagnosing multiple sclerosis
Official title: Comparison of the Performance of the 2024 and 2017 McDonald Criteria for the Diagnosis of Multiple Sclerosis in Real Life
Run by Central Hospital, Nancy, France · NCT07492667 · Data updated 2026-11-12
This study will test whether the 2024 McDonald rules diagnose more people with MS at their first neurology visit than the 2017 rules for patients with a first clinical or radiological event suggestive of MS.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 2 sites (Ars-Laquenexy, Lorraine and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07492667 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults covered by French national health insurance who are seen for the first time in neurology at Nancy University Hospital or Metz-Thionville (Mercy) with a clinical and/or radiological event suggestive of MS and no alternative diagnosis.
✕Probably not a fit
Patients with alternative explanatory diagnoses (e.g., neuromyelitis optica spectrum disorder, anti‑MOG disease, sarcoidosis, tumor, vascular or infectious causes) or those who cannot undergo at least one brain MRI are unlikely to benefit from the comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational comparison applying both the 2017 and 2024 McDonald diagnostic criteria to patients who present for the first time with a clinical or radiological event suggestive of multiple sclerosis at two French hospitals. The 2024 criteria add previously borderline presentations, new imaging approaches, ophthalmological data, and the CSF kappa index, and the study will record how often each set of rules yields a diagnosis at initial assessment. Investigators will also compare proposed kappa index thresholds against the reference test of IgG oligoclonal bands in CSF. No experimental treatments are given; the project documents real-life diagnostic yield and thresholds in routine clinical workups.
Why it matters
Potential benefit: If the 2024 criteria identify more patients earlier, affected people could start treatment sooner and potentially have less long-term disability.
How similar studies have gone: Prior comparisons of earlier McDonald revisions showed that newer criteria can increase early MS diagnosis, but the 2024 changes—especially use and thresholding of the kappa index—have limited real-world validation to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients covered by French national health insurance * Consulting or hospitalized in neurology at Nancy University Hospital or Metz-Thionville Regional Hospital, Mercy site * For the first time for a clinical and/or radiological event suggestive of multiple sclerosis according to the Nancy or Mercy hospital neurologist responsible for the patient Exclusion Criteria: * Clinical and/or radiological event suggestive of something other than multiple sclerosis, such as neuromyelitis optica spectrum disorder, pathologies associated with anti-MOG antibodies, sarcoidosis, syndromes associated with anti-neuronal antibodies, etc., as well as vascular, infectious, tumor, or paraneoplastic disorders * Inability to perform at least one brain MRI during initial management (contraindication to this examination).
Where it's running
-
Centre Hospitalier Régional de Metz, site Mercy
Ars-Laquenexy, Lorraine, France Recruiting -
Centre Hospitalier Régional Universitaire
Nancy, Lorraine, France Recruiting
Study contacts
- Study coordinator: Guillaume Mathey, MD PhD
- Email: g.mathey@chru-nancy.fr
- Phone: +333383851688
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.