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New MRI clue could slash MS misdiagnosis rates

NCT ID NCT04495556

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

420 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • St. Michael's Hospital of Unity Health Toronto

    Toronto, Ontario, M5B1W8, Canada

  • The University of Texas at Austin

    Austin, Texas, 78759, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    Los Angeles, California, 90089, United States

  • University of Vermont

    Burlington, Vermont, 05405, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63130, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

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