Studies whether multiple sclerosis relapses can occur without MRI signs
Examines brain and spine MRI scans and blood markers in people with relapsing multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?
Key facts
- Where
- Colmar, Dijon, Haguenau, Metz, Mulhouse, Nancy, Reims, and Strasbourg, FranceSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07545889, who can take part
Where in France
- Hospices Civils de ColmarColmar, FranceNo longer taking part
- CHU de Dijon - BourgogneDijon, FranceNo longer taking part
- Centre Hospitalier de HaguenauHaguenau, FranceNo longer taking part
- Chr Metz-ThionvilleMetz, FranceNo longer taking part
- Grpe Hosp Region Mulhouse & Sud AlsaceMulhouse, FranceNo longer taking part
- CHU de NancyNancy, FranceNo longer taking part
- CHU ReimsReims, FranceNo longer taking part
- Hopitaux Universitaires de StrasbourgStrasbourg, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Strasbourg, France
- Trial code
- NCT07545889
- Record updated
- 22 April 2026
- Original description
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.Read full original descriptionShow less
Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?
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.
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; Patient affiliated with or a beneficiary of a social security health insurance scheme.
Exclusion: Corticosteroid bolus or plasma exchange in the month preceding inclusion; Chronic treatment with corticosteroids or immunosuppressants for another pathology; Diagnosis of chronic psychotic disorder; Infection within the past week; Uncontrolled cardiac, renal, or hepatic pathology; Primary progressive or secondary progressive multiple sclerosis; Body temperature > 38.5°C at V0 (baseline visit); Contraindication to MRI or gadolinium; 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).