Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?

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Conditions studied: Multiple Sclerosis, RRMS, Multiple Sclerosis (MS) - Relapsing-remitting

In brief

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.

Key facts

Study ID

NCT07545889

Run by

University Hospital, Strasbourg, France

People needed

136

Starts

2026-09-01

Expected to finish

2030-05-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Hospices Civils de Colmar — Colmar, France
• CHU de Dijon Bourgogne — Dijon, France
• Centre Hospitalier de Haguenau — Haguenau, France
• Chr Metz-Thionville — Metz, France
• Grpe Hosp Region Mulhouse & Sud Alsace — Mulhouse, France
• CHU de Nancy — Nancy, France
• Chu Reims — Reims, France
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France

Full record on ClinicalTrials.gov

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