protocolSection identificationModule nctId: NCT06274671, orgStudyIdInfo id: 23-24-09, briefTitle: Glymphatic MRI in Clinically Isolated Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, descriptionModule briefSummary: The brain possesses a system to get rid of unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients.The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS., conditionsModule conditions: Clinically Isolated Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic Resonance Imaging, outcomesModule primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of structural integrity in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of disease activity in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of enlarged Wirchow-Robin spaces in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of microstructural altertions in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of brain perfusion in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with clinical measures of disease severity, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of axonal injury in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of astrocytis integrity in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of glymphatic activity in CIS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Exeter, city: Exeter, country: United Kingdom, contacts name: Edoardo R de Natale, MD, role: CONTACT, email: e.de-natale@exeter.ac.uk, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False