New MRI clue could slash MS misdiagnosis rates
NCT ID NCT04495556
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a specific feature on brain MRI scans—called the central vein sign—can improve the accuracy of multiple sclerosis (MS) diagnosis. Currently, up to 1 in 5 people diagnosed with MS are later found not to have the disease, leading to unnecessary and potentially harmful treatments. The study will enroll 420 participants with typical or atypical MS symptoms across North America and compare MRI findings at the start and after 24 months to see if the central vein sign helps confirm or rule out MS.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a more accurate and faster way to diagnose multiple sclerosis, reducing misdiagnosis and unnecessary treatments.
- What could go wrong
- This is an observational study, not a treatment trial. The central vein sign may not prove reliable enough to replace current diagnostic methods, and results may not apply to all patient groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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420 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will recruit a total 400 participants. The study will include 200 patients presenting with typical first syndromes and will enroll an additional 200 patients with atypical presentations and radiological suspicion of the disease. Participants will be recruited from the patient populations followed at eleven different sites including: Cleveland Clinic, Johns Hopkins University, University of California San Francisco, University of Texas Austin, University of Colorado Denver, University of Toronto (St. Michael's Hospital), University of Vermont, University of Pennsylvania, Cedars Sinai Medical Center, University of Southern California, and Yale University. Study investigators will confirm eligibility criteria, and participants will then be enrolled into the study.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria for participants with typical presentations will include: 1. Age 18 to 65 inclusive 2. Referral to a study academic site for a clinical suspicion of MS 3. Onset with typical symptom onset including: acute unilateral optic neuritis, double vision due to an internuclear ophthalmoplegia or sixth nerve palsy, facial sensory loss or trigeminal neuralgia in a young adult (\<40 years of age), cerebellar ataxia and nystagmus, partial myelopathy, sensory symptoms in a CNS pattern, Lhermitte's symptom, asymmetric limb weakness, urge incontinence or erectile dysfunction, or other neurological presentation considered to be typical by the site investigator. 4. Able to provide written informed consent to participate in the study 5. For participants referred for clinical suspicion of multiple sclerosis who had workup prior to referral or who are taking disease-modifying therapies for MS, digital availability of diagnostic cranial MRI with gadolinium within 3 months of initial symptoms 6. Onset of typical neurological symptoms within 10 years of screening. Inclusion criteria for participants with atypical presentations will include: 1. Age 18 to 65 inclusive 2. Referral to a study academic site for a suspicion of MS 3. Onset with atypical onset including: bilateral optic neuritis or unilateral optic neuritis with a poor visual recovery, complete gaze palsy or fluctuating ophthalmoparesis, intractable nausea, vomiting, or hiccups, complete transverse myelopathy with bilateral motor and sensory involvement, encephalopathy, subacute cognitive decline, headache or meningismus, isolated fatigue or asthenia, constitutional symptoms, other clinical presentations considered atypical by the site investigator (examples include: vague or patchy sensory symptoms, pain, short lasting bilateral blurred vision, etc.), or absence of clinical symptoms with MRI features suggestive of MS 4. Able to provide written informed consent to participate in the study 5. For participants referred for clinical suspicion of multiple sclerosis who had workup prior to referral or who are taking disease-modifying therapies for MS, digital availability of diagnostic cranial MRI with gadolinium within 3 months of initial symptoms 6. Onset of atypical neurological symptoms within 10 years of screening. Exclusion Criteria: Exclusion criteria for both typical and atypical populations will include: 1. Contraindication to MRI studies; metal or metal implants incompatible with MRI 2. Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g. tremor) 3. Contraindication to use of gadolinium containing contrast agents (allergy or renal failure) 4. Treatment with systemic corticosteroids in the 4 weeks preceding enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Johns Hopkins University
Baltimore, Maryland, 21218, United States
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St. Michael's Hospital of Unity Health Toronto
Toronto, Ontario, M5B1W8, Canada
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The University of Texas at Austin
Austin, Texas, 78759, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Southern California
Los Angeles, California, 90089, United States
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University of Vermont
Burlington, Vermont, 05405, United States
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Washington University in St. Louis
St Louis, Missouri, 63130, United States
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Yale University
New Haven, Connecticut, 06520, United States
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Other studies related to the condition(s) this trial covers.
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