Multiple SclerosisMS-ReBSNCT05204459
MS-ResearchBiomarkerS
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 11 Nov 2041
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with the following conditions or healthy volunteers are eligible to participate in the study: 1. Multiple sclerosis (MS), clinically isolated syndrome (CIS), or radiologically isolated syndrome (RIS) 2. Neuromyelitis optica spectrum disorders (NMOSD) 3. Myelin oligodendrocyte glycoprotein (MOG) antibody associated disorders (MOGAD) 4. Neurological disorder other than MS and related disorders 5. Healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Omar Al-Louzi, MD, 310-423-4008, omar.allouzi@cshs.org
Group Neurology Research, (310)-423-6472, GroupNeurologyMSProgramResearch@cshs.org
About this study
Official title: Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders
This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and/or spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.
Read the detailed description
Screening:
Prospective participants will be screened at Cedars-Sinai Medical Center (CSMC) through a comprehensive review of their medical and MRI records done as part of standard of care to determine if they are eligible to participate in this study. If they never had an MRI at CSMC, they will be asked to provide records of an MRI done at another site. If the study team determines that they are eligible to continue participating, then they will move on to the main research study.
Main Research Study:
The following items will be collected as part of the main research study:
- Demographic data and medical history, including medications, family, and social history
- Complete a series of quantitative disability assessments,
- Collection of historic MRI data obtained as part of standard of care
Optional Sub-study:
Participants are not required to take part in the optional sub-study and can choose which sub-study procedures they would want to undergo. Participants can say no to the sub-study, and still remain in the main study. The optional sub-study involves undergoing one or more of the procedures below:
- Research blood draw
- Additional blood sample for a genetic and/or stem cell sub-study
- Visual assessment
- Research MRI
How long will participants be in the study? There is no prespecified end date for this study. Participants may remain in the main study as long as they are (1) willing to participate, (2) remain eligible for the study procedures, and (3) the study remains open.
Compensation for Participating Participants will be provided a voucher to cover parking expenses at Cedars-Sinai Medical Center during their participation in this research study if they undergo the optional sub-study procedures.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive, Clinically Isolated Syndrome, Radiologically Isolated Syndrome
- Keywords
- 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
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Neuromyelitis Optica, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Autoimmune Diseases of the Nervous System, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RRMS, SPMS, PPMS, CIS or RIS | Multiple Sclerosis (relapsing-remitting, primary or secondary progressive forms), clinically isolated syndrome, or radiologically isolated syndrome | |
| NMOSD | Neuromyelitis optica spectrum disorders | |
| MOGAD | Myelin oligodendrocyte glycoprotein antibody disorders | |
| Neurological disorder other than MSRD | Neurological disorders due to neurodegenerative, vascular, or headache conditions that are not related to multiple sclerosis or related disorders. | |
| Healthy controls | Healthy controls with no known neurological conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying risk factors for disability progression
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
Measured: 10 years
Secondary outcomes (3)
Effect of disease modifying therapy
Assess the effect modification of various Food and Drug Administration(FDA)-approved disease modifying therapy on disability risk
Measured: 10 years
Identify factors associated with visual disability and optic neuropathy in multiple sclerosis and related disorders
Using retinal structural and functional testing, this study will track longitudinal evolution of visual dysfunction and retinal injury
Measured: 10 years
Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start11 Nov 2021
- Primary completion11 Nov 2041 (estimated)
- Study completion11 Nov 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Al-Louzi, Cedars-Sinai Medical Center
- Investigators
- Omar Al-Louzi, MD, Principal investigator, Cedars-Sinai Medical CenterMarwa Kaisey, MD, Study director, Cedars-Sinai Medical CenterBrooke Guerrero, MD, Study director, Cedars-Sinai Medical CenterLaura Locke, CRNP, Study director, Cedars-Sinai Medical CenterPascal Sati, PhD, Study director, Cedars-Sinai Medical CenterNancy Sicotte, MD, Study chair, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204459
- Sponsor's protocol ID
- STUDY00001690
- Acronym
- MS-ReBS
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tayem AJ, Liu A, Manukyan S, Subhi M, Luskin E, Quah B, Nair SM, Has Silemek AC, Zabala G, Cui Y, Locke L, Barreras P, Kaisey M, Calsavara V, Reich DS, Sicotte NL, Sati P, Al-Louzi O. Paramagnetic Rim Lesions Are Associated With Trans-Synaptic Degeneration of the Visual Pathway in Multiple Sclerosis. Ann Clin Transl Neurol. 2026 Mar 17:10.1002/acn3.70352. doi: 10.1002/acn3.70352. Online ahead of print.
PubMed 41841206