๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-29

Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis (NCT04495556)

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: The Cleveland Clinic

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.

Who can join: Review the eligibility criteria below.

Location: Cedars-Sinai Medical Center โ€” Los Angeles, California

Age range: 18 Years to 65 Years

๐Ÿงช Interventions in This Study

  • MRI (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • Cedars-Sinai Medical Center โ€” Los Angeles, California
  • University of Southern California โ€” Los Angeles, California
  • University of Colorado โ€” Aurora, Colorado
  • Yale University โ€” New Haven, Connecticut
  • Johns Hopkins University โ€” Baltimore, Maryland
  • Washington University in St. Louis โ€” St Louis, Missouri
  • Cleveland Clinic Foundation โ€” Cleveland, Ohio
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • The University of Texas at Austin โ€” Austin, Texas
  • University of Vermont โ€” Burlington, Vermont
  • St. Michael's Hospital of Unity Health Toronto โ€” Toronto, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—