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In the case of the autoimmune disease multiple sclerosis (MS), a rapid diagnosis is crucial to keeping nerve damage at bay. The McDonald criteria, revised in 2024, are helpful in this regard. A research team at the MHH has now conducted a study to investigate how the newly added diagnostic criteria – such as damage to the optic nerve – affect the early detection of MS. The result: the expansion of the diagnostic criteria contributes significantly to an increase in the proportion of first-time diagnoses. This means that more cases of MS are being detected in good time that would previously have remained undiagnosed for longer.
Multiple sclerosis (MS) is the most common chronic autoimmune disease of the central nervous system. An early and accurate diagnosis is crucial for improving the effectiveness of treatment and reducing nerve damage. To standardise and speed up diagnosis, the so-called McDonald criteria were introduced in 2001 and have since been revised several times, most recently in 2024. They combine clinical findings – such as visual disturbances, sensory disturbances or unsteadiness of gait – with results from magnetic resonance imaging (MRI), which reveals changes in the brain and spinal cord, as well as inflammatory markers in the cerebrospinal fluid. In 2024, the diagnostic criteria were revised and expanded. New additions include, amongst other things, changes to the optic nerve. Furthermore, a diagnosis can now be made solely on the basis of the MRI scan, without the need for clinical symptoms to be present. In a study, a research team from the Department of Neurology and Clinical Neurophysiology at Hannover Medical School (MHH) has now compared the old and new diagnostic criteria. The result: the newly included diagnostic criteria meant that more people with MS who would previously have gone undetected could be identified at an early stage. The findings have been published in the journal ‘eClinicalMedicine – The Lancet Discovery Science’.
Lesions in the optic nerve are also significant
“Our findings show that the McDonald criteria, revised in 2024, significantly increase the proportion of first-time diagnoses – by almost ten percentage points,” says study leader Prof. Dr Thomas Skripuletz, senior registrar at the clinic. Cases that were previously unclear can now be classified more quickly and reliably. Most of the additional diagnoses resulted from the inclusion of the optic nerve as a fifth site for inflammatory foci, known in technical terms as lesions. Until now, MRI imaging had focused on lesions in four affected areas: directly around the brain ventricles filled with cerebrospinal fluid; in the cerebral cortex, brainstem or cerebellum; and in the spinal cord. “Including the optic nerve is important because it is also damaged by inflammation of the central nervous system,” emphasises the neurologist. The first signs of MS are therefore often blurred vision, pain when moving the eyes and impaired colour perception. “In our study, taking optic nerve involvement into account was the main reason for the earlier diagnosis.”
Diagnosis possible before symptoms appear
Optic neuritis can be detected using MRI, as well as optical coherence tomography (OCT) and measurements of so-called visual evoked potentials (VEP). The latter assess the conductivity and functionality of the visual pathway from the retina to the brain. It is also significant that, for the first time, patients with radiologically isolated syndrome (RIS) have been included in MS diagnostics. “Sometimes an MRI scan is carried out – for example, following an accident – and it reveals changes that are typical of MS,” explains Professor Skripuletz. However, in the absence of clinical symptoms, MS was previously considered ‘unconfirmed’. “Thanks to the new criteria, we can now make the diagnosis based on the MRI scan at an earlier stage, before symptoms appear.”
Diagnostic tools from routine clinical practice are sufficient
The McDonald criteria, revised in 2024, also include new MRI markers in the diagnostic catalogue. However, these were not taken into account in the study because the researchers only used conventional diagnostic tools available in routine clinical practice. The assessment of these new MRI markers requires modern imaging techniques as well as a high level of neuroradiological expertise. Furthermore, the added benefit of this specialised imaging is limited to only a small group of people with MS. “The new MRI markers are promising, but many patients can already be diagnosed at an early stage using established MRI, VEP and cerebrospinal fluid diagnostics,” says Dr Felix Konen, a neurologist at the clinic and lead author of the study.
Cerebrospinal fluid diagnostics play a key role
A new cerebrospinal fluid biomarker, which indicates inflammation in the central nervous system, has been incorporated into the diagnostic criteria. The so-called kappa index indicates MS with a reliability similar to that of oligoclonal bands. With the latter, the antibody pattern in cerebrospinal fluid and blood serum samples is examined and directly compared. However, the new marker can be measured fully automatically and more quickly in the laboratory. “Our study demonstrates that the McDonald criteria, revised in 2024, significantly increase the proportion of patients in whom MS is diagnosed at the initial examination – even when using conventional diagnostic tools,” emphasises Professor Skripuletz. “Our findings support a pragmatic implementation of the revised criteria in clinical practice and underpin the central role of cerebrospinal fluid diagnostics. With the inclusion of the kappa index, cerebrospinal fluid diagnostics gains further significance and can contribute to a faster and more standardised diagnosis. Without cerebrospinal fluid diagnostics, a quarter of patients would not have been diagnosed according to the McDonald criteria revised in 2024.” Further studies should now evaluate the additional potential benefits of the new MRI markers and clarify for which people with MS the additional diagnostic benefit justifies the necessary staffing and technical resources.
Keyword: Multiple sclerosis
Multiple sclerosis (MS) is the most common chronic autoimmune disease of the central nervous system, meaning it affects the brain and spinal cord. In this condition, immune cells that have gone astray attack the protective sheaths surrounding the nerve fibres. This results in areas of inflammation (lesions), impairs the transmission of nerve impulses and damages the nerves. It is estimated that more than 280,000 people in Germany live with MS. More than 15,000 new cases are diagnosed each year. Young adults are predominantly affected. The course of the disease varies from person to person. Symptoms and limitations in daily life can vary in severity. It can also progress largely unnoticed. An early diagnosis is therefore all the more important in order to manage the disease and minimise long-term damage to the nervous system.
SERVICE:
Further information is available from Prof. Dr Thomas Skripuletz, skripuletz.thomas@mh-hannover.de.
The original paper “Applying the 2024-revised McDonald criteria for multiple sclerosis using conventional diagnostic tools: a single-centre prospective cohort study in Germany” can be found here: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(26)00351-2/fullt...
Neurologists Dr Felix Konen (left) and Prof. Dr Thomas Skripuletz are examining an antibody pattern ...
Copyright: Karin Kaiser/MHH
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