Central Vein Sign in Multiple Sclerosis Extension Study
What it found
No result yet.
What was tested
Treatment tested
- MRI Contrast
What it measured
Main measures
MRI Outcomes- CVS
Change assessed over 48 months. Scans done in the CAVS-MS core study (Baseline and Month 24) will be compared to scan done at Month 48.
MRI lesionsMRI Outcomes- PRL
Change assessed over 48 months. Scans done in the CAVS-MS core study (Baseline and Month 24) will be compared to scan done at Month 48.
MRI lesionsSmouldering inflammationClinical Outcomes- Diagnosis of MS by 2017 Diagnostic Criteria
McDonald criteria will be reviewed at Month 48.
Clinical Outcomes- EDSS
EDSS will be assessed at the Month 48 visit.
Disability progressionClinical Outcomes- Multiple Sclerosis Functional Composite (MSFC-4)
MSFC-4 will be assessed at the Month 48 visit.
Disability progressionVisionThinking and memoryWalking and mobilityArm and hand function
Who could take part
MS (type not specified) · 18 to 65
Inclusion Criteria: * Participants must be enrolled in and meet all inclusion criteria of the CAVS-MS study. * Must have participated in the CAVS-MS study and have completed month 24 visits. * Able to provide written informed consent to participate in the study. Exclusion Criteria: * Contraindication to MRI studies; metal or metal implants incompatible with MRI * Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g. tremor).
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
Multiple sclerosis (MS) is a common disease of the central nervous system that affects almost 1 million people in the United States. However, diagnosing MS can be difficult and often leads to misdiagnosis. More sensitive and specific biomarkers are needed to help with the diagnosis, prognosis, and evaluation of treatment response for MS. The central vein sign (CVS) and the paramagnetic rim lesion (PRL) are two biomarkers that have shown promise in improving diagnostic accuracy for MS. The goal of this study is to provide pilot information on the long-term performance of the CVS and PRL to help diagnose and follow people with MS. The study will follow 40 participants over 48 months to determine if the CVS and PRL help make a diagnosis of MS and how they can be used to follow people with MS. The study will also examine how PRL and CVS change over 48 months. The results of this pilot study will inform the development of a grant application to extend 5-year follow-up for all 420 participants of the CAVS-MS study. The study will use high-resolution T2*-weighted MRI to detect the CVS and PRLs. An MRI of the brain with contrast will be used to examine CVS, PRL and longitudinal analysis of lesions that slowly grow over time (slowly expanding lesions [SELs]). The results of this study have the potential to improve the accuracy of diagnosing and treating MS.
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History
Started
Oct 2025
Main results due
Dec 2026
Finished
Dec 2027
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