Multiple Sclerosis (MS) Clinical Trials

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Central Vein Sign in Multiple Sclerosis Extension Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Los Angeles
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Contact Information
Primary
Meghan Kilbane
kilbanm@ccf.org
216-445-9845
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Confirmed diagnosis of MS at the end of the CAVS-MS study
Experimental: Unconfirmed diagnosis of MS (at risk for MS) at the end of the CAVS-MS study
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic
Collaborators: Cedars-Sinai Medical Center, University of Pennsylvania

This content was sourced from clinicaltrials.gov