Status:
ACTIVE_NOT_RECRUITING
Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Pennsylvania
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
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 inaccura...
Detailed Description
The CentrAl Vein Sign in MS (CAVS-MS) study seeks to answer whether the central vein sign (CVS) can be used as a sensitive and specific diagnostic marker for a diagnosis of MS. The study will investig...
Eligibility Criteria
Inclusion
- Inclusion criteria for participants with typical presentations will include:
- Age 18 to 65 inclusive
- Referral to a study academic site for a clinical suspicion of MS
- 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.
- Able to provide written informed consent to participate in the study
- 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
- Onset of typical neurological symptoms within 10 years of screening.
- Inclusion criteria for participants with atypical presentations will include:
- Age 18 to 65 inclusive
- Referral to a study academic site for a suspicion of MS
- 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
- Able to provide written informed consent to participate in the study
- 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
- Onset of atypical neurological symptoms within 10 years of screening.
Exclusion
- Exclusion criteria for both typical and atypical populations will include:
- 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)
- Contraindication to use of gadolinium containing contrast agents (allergy or renal failure)
- Treatment with systemic corticosteroids in the 4 weeks preceding enrollment.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04495556
Start Date
June 11 2020
End Date
January 1 2027
Last Update
October 2 2025
Active Locations (11)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Southern California
Los Angeles, California, United States, 90089
3
University of Colorado
Aurora, Colorado, United States, 80045
4
Yale University
New Haven, Connecticut, United States, 06520