Multicenter Prospective Study Analyzing the Occurrence of Multiple Scl
Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?
What it found
No result yet.
What was tested
Treatment tested
- Early Cerebro-spinal MRI
- Biomarker Assessment
- Clinical and Neuropsychological Evaluations
What it measured
Main measures
Proportion of RRMS Patients with Absence or Presence of Gadolinium-Enhancing Lesion(s) on Brain and Spinal Cord MRI
performed between Day 0 and Day 6
RelapsesMRI lesions
Who could take part
Relapsing MS · 18 to 70 · EDSS 0 to 7.0
Show the full criteria
Inclusion criteria
* 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. * Patient affiliated with or a beneficiary of a social security health insurance scheme.
Exclusion criteria
* 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. * Contraindication to MRI or gadolinium. * Uncontrolled cardiac, renal, or hepatic pathology. * Patient participating in another interventional study or still within an exclusion period. * Pregnant or breastfeeding woman. * Severe claustrophobia. * Patient deprived of liberty (e.g., incarcerated).
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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. Each participant will undergo clinical assessment, cognitive and psychological evaluation, and early MRI, with follow-up at 6 months. An ancillary study will explore blood biomarkers (NfL, GFAP, and circulating DNA) to help differentiate true inflammatory relapses from ACES. This study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.
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History
Started
Sept 2026
Main results due
Sept 2029
Finished
May 2030