[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634915":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":33,"locations":40,"responsibleParty":153,"collaborators":11,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":157,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":11,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":183,"whyStopped":11,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RRMS Patients with Acute Neurological Exacerbations","EXPERIMENTAL",null,[13,14,15],"Other: Early Cerebro-spinal MRI","Diagnostic Test: Biomarker Assessment","Diagnostic Test: Clinical and Neuropsychological Evaluations",[17,21,29],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"Early Cerebro-spinal MRI","A standardized MRI of the brain and spinal cord with gadolinium injection. Performed very early during an acute neurological exacerbation, specifically between Day 0 and Day 6 (J0 to J6).\n\nTo detect the presence or absence of gadolinium-enhancing lesions, which is the study's primary endpoint.\n\nIncludes Susceptibility Weighted Imaging (SWI) to look for paramagnetic rim lesions and post-gadolinium FLAIR sequences to detect leptomeningeal enhancement.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Biomarker Assessment","Routine blood and urine tests, including CRP, blood count, and urinalysis (leukocytes, nitrites) to rule out infections that could cause a pseudo-relapse.\n\nAncillary Study Biomarkers: For consenting patients, blood samples are collected to measure specific molecular markers:\n\nNfL (Neurofilaments): A marker of axonal damage. GFAP (Glial Fibrillary Acidic Protein): A marker of astrocytic activation. cfDNA (Cell-free DNA): Used to assess cellular stress or death",[9],[27,28],"biological markers","NfL, GFAP, and cfDNA",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Clinical and Neuropsychological Evaluations","Standardized Scales:\n\n* EDSS (Expanded Disability Status Scale): Used to measure the degree of neurological disability at inclusion and at the 6-month follow-up.\n* SDMT (Symbol Digit Modalities Test) and CSCT (Computerized Speed Cognitive Test): Used to assess cognitive processing speed.\n\nFunctional Disorder Screening: A specific clinical examination is conducted to identify positive signs of Functional Neurological Disorders (FND\u002FTNF), which may mimic a relapse.",[9],[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Kévin BIGAUT, MCU-PH","CONTACT","+33 (0)3 88 12 85 68","+33","kevin.bigaut@chru-strasbourg.fr",[41,58,72,86,100,114,128,142],{"facility":42,"status":11,"city":43,"state":11,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospices Civils de Colmar","Colmar","68024","France","FR",{"type":48,"coordinates":49},"Point",[50,51],7.35584,48.08078,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":38,"email":57},"François SELLAL, PH","+33 (0)3 89 12 41 50","francois.sellal@ch-colmar.fr",{"facility":59,"status":11,"city":60,"state":11,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"CHU de Dijon Bourgogne","Dijon","21079",{"type":48,"coordinates":63},[64,65],5.01391,47.31344,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":70,"phoneExt":38,"email":71},"Thibault MOREAU, PU-PH","+33 (0)3 80 29 55 84","thibault.moreau@chu-dijon.fr",{"facility":73,"status":11,"city":74,"state":11,"zip":75,"country":45,"countryCode":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Centre Hospitalier de Haguenau","Haguenau","67504",{"type":48,"coordinates":77},[78,79],7.79051,48.81557,{"lat":79,"lon":78},[82],{"name":83,"role":36,"phone":84,"phoneExt":38,"email":85},"Sophie CARRE, PH","+33 (0)3.88.06.31.02","sophie.carre@ch-haguenau.fr",{"facility":87,"status":11,"city":88,"state":11,"zip":89,"country":45,"countryCode":46,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Chr Metz-Thionville","Metz","57085",{"type":48,"coordinates":91},[92,93],6.17269,49.11911,{"lat":93,"lon":92},[96],{"name":97,"role":36,"phone":98,"phoneExt":38,"email":99},"Basile WITTWER, PH","+33 (0)3 87 55 77 77","basile.wittwer@chr-metz-thionville.fr",{"facility":101,"status":11,"city":102,"state":11,"zip":103,"country":45,"countryCode":46,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Grpe Hosp Region Mulhouse & Sud Alsace","Mulhouse","68051",{"type":48,"coordinates":105},[106,107],7.32866,47.75205,{"lat":107,"lon":106},[110],{"name":111,"role":36,"phone":112,"phoneExt":38,"email":113},"Mathilde GOUDOT, PH","+33 (0)3 89 64 64 64","mathilde.goudot@ghrmsa.fr",{"facility":115,"status":11,"city":116,"state":11,"zip":117,"country":45,"countryCode":46,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"CHU de Nancy","Nancy","54035",{"type":48,"coordinates":119},[120,121],6.18496,48.68439,{"lat":121,"lon":120},[124],{"name":125,"role":36,"phone":126,"phoneExt":38,"email":127},"Guillaume MATHEY, MCU-PH","+33 (0)3 83 85 16 88","G.MATHEY@chru-nancy.fr",{"facility":129,"status":11,"city":130,"state":11,"zip":131,"country":45,"countryCode":46,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Chu Reims","Reims","51092",{"type":48,"coordinates":133},[134,135],4.02853,49.26526,{"lat":135,"lon":134},[138],{"name":139,"role":36,"phone":140,"phoneExt":38,"email":141},"Sami, CCU-AH","+33 (0)3 26 78 70 75","sbenhammida@chu-reims.fr",{"facility":143,"status":11,"city":144,"state":11,"zip":145,"country":45,"countryCode":46,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Hôpitaux Universitaires de Strasbourg","Strasbourg","67098",{"type":48,"coordinates":147},[148,149],7.74553,48.58392,{"lat":149,"lon":148},[152],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},{"type":154,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100634915","multicenter-prospective-study-analyzing-the-occurrence-of-multiple-sclerosis-relapses-without-radiological-evidence-myth-or-reality-100634915",false,"NCT07545889","Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?","MYTH-MS","Inclusion Criteria:\n\n* Adult aged 18 to 70 years.\n* Relapsing-Remitting Multiple Sclerosis according to the McDonald 2024 criteria.\n* Patient receiving disease-modifying therapy (DMT) for multiple sclerosis.\n* Most recent EDSS score between 0 and 7.0, dating back less than 1 year.\n* Patient presenting with a neurological exacerbation lasting more than 24 hours and less than 7 days (excluding fatigue and pain alone).\n* Patient capable of understanding the objectives and risks associated with the study and who has provided informed consent.\n* Patient affiliated with or a beneficiary of a social security health insurance scheme.\n\nExclusion Criteria:\n\n* Primary progressive or secondary progressive multiple sclerosis.\n* Diagnosis of chronic psychotic disorder.\n* Infection within the past week.\n* Body temperature \\> 38.5°C at V0 (baseline visit).\n* Corticosteroid bolus or plasma exchange in the month preceding inclusion.\n* Chronic treatment with corticosteroids or immunosuppressants for another pathology.\n* Contraindication to MRI or gadolinium.\n* Uncontrolled cardiac, renal, or hepatic pathology.\n* Patient participating in another interventional study or still within an exclusion period.\n* Pregnant or breastfeeding woman.\n* Severe claustrophobia.\n* Patient deprived of liberty (e.g., incarcerated).","ALL","18 Years","70 Years",{"count":166,"type":167},136,"ESTIMATED","INTERVENTIONAL",[170],"NA","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.\n\nWhile 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.\n\nThe 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.\n\nA 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.\n\nThis study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.",[173,174,175],"Multiple Sclerosis","RRMS","Multiple Sclerosis (MS) - Relapsing-remitting",[173,177,178,179,180,181,182],"Relapsing-Remitting Multiple Sclerosis","Acute Clinical Events with Stable MRI (ACES)","Gadolinium-enhancing lesions","MRI-negative relapse","Functional Neurological Disorder","Pseudo-relapse","NOT_YET_RECRUITING","2026-04-15",{"date":186,"type":187},"2026-04-22","ACTUAL",{"date":189,"type":167},"2026-09-01",{"date":191,"type":167},"2030-05-01",{"name":5,"class":6},8]