NCT07545889
Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?
Not Yet Recruiting · Not Applicable · University Hospital, Strasbourg, France · registry updated 2026-04-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The MYTH-MS study is a multicenter prospective study investigating the occurrence of clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) in the absence of radiological activity on MRI. While MS relapses are typically associated with gadolinium-enhancing lesions on MRI, some patients present with acute neurological symptoms without radiological correlates, referred to as acute clinical events with stable MRI (ACES). The frequency, mechanisms, and clinical relevance of these events remain unclear due to limitations in previous studies. The primary objective is to determine the proportion of RRMS patients experiencing a relapse without gadolinium-enhancing lesions on early brain and spinal MRI. Secondary objectives include identifying clinical, radiological, biological, and psychological predictors, assessing neurologists' diagnostic accuracy, and evaluating clinical outcomes such as disability, cognition, and quality of life over a 6-month follow-up. A total of 136 patients with recent neurological exacerbations will be included....
Inclusion
- Adult aged 18 to 70 years.
- Relapsing-Remitting Multiple Sclerosis according to the McDonald 2024 criteria.
- Patient receiving disease-modifying therapy (DMT) for multiple sclerosis.
- Most recent EDSS score between 0 and 7.0, dating back less than 1 year.
- Patient presenting with a neurological exacerbation lasting more than 24 hours and less than 7 days (excluding fatigue and pain alone).
- Patient capable of understanding the objectives and risks associated with the study and who has provided informed consent.
Exclusion
- Primary progressive or secondary progressive multiple sclerosis.
- Diagnosis of chronic psychotic disorder.
- Infection within the past week.
- Body temperature \> 38.5°C at V0 (baseline visit).
- Corticosteroid bolus or plasma exchange in the month preceding inclusion.
- Chronic treatment with corticosteroids or immunosuppressants for another pathology.