Observational Study of Risk Factors for Disability Progression in MS and Related Disorders

This observational study aims to understand what factors lead to disability progression in Multiple Sclerosis (MS) and related conditions like Relapsing-Remitting MS, Primary Progressive MS, Secondary Progressive MS, and Clinically Isolated Syndrome (CIS). Researchers are looking at information from visual assessments, blood tests, and past and ongoing MRI scans of the brain, eyes, and spinal cord. The goal is to see if combining these details can help predict changes in disability over 10 years. You may be eligible if you are 18 or older and have a diagnosis of MS, CIS, NMOSD (Neuromyelitis Optica Spectrum Disorder), or MOG-related encephalomyelitis.

Study design
This is an observational study with a planned enrollment of 1000 participants. It is not a treatment study, but rather aims to collect information.
What's involved
You would provide demographic and medical history, complete disability assessments, and allow researchers to collect your historic MRI data. There is also an optional sub-study that may involve a research blood draw, additional blood samples for genetic or stem cell studies, visual assessment, or a research MRI. There is no prespecified end date for this study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for identifying risk factors for disability progression is measured at 10 years.

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NCT05204459

MS-ResearchBiomarkerS

Recruiting
Not specifiedAges 18+Observational
Cedars-Sinai Medical Center
~1,000 participants
Updated 2024-02-06 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identifying risk factors for disability progression
Measured over 10 years
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive
Clinically Isolated Syndrome
Radiologically Isolated Syndrome
Neuromyelitis Optica Spectrum Disorders
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Neurologic Autoimmune Disease
Neurologic Disorder
Healthy Aging
1 sites across 1 states
California1
  • Omar Al-Louzi, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
  • Marwa Kaisey, MD · STUDY_DIRECTOR · Cedars-Sinai Medical Center
  • Brooke Guerrero, MD · STUDY_DIRECTOR · Cedars-Sinai Medical Center
  • Laura Locke, CRNP · STUDY_DIRECTOR · Cedars-Sinai Medical Center
  • Pascal Sati, PhD · STUDY_DIRECTOR · Cedars-Sinai Medical Center
  • Nancy Sicotte, MD · STUDY_CHAIR · Cedars-Sinai Medical Center

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Eligibility criteria

Inclusion

Subjects who meet any one of the following diagnostic criteria:
Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.
Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.
Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.
Diagnosis of neurological disorders other than MSRD.
Healthy volunteer.
Age ≥18.
Able to give informed consent.

Exclusion

Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).
Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.
Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT/OCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).
  • Identifying risk factors for disability progression10 years

    To investigate whether combining information from peripheral blood biomarkers, retinal structural, visual function, as well as historical and ongoing longitudinal MRIs (brain, cervical, and/or thoracic spinal cord) can predict quantitative disability progression risk