MS-ResearchBiomarkerS (MS-ReBS)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome; Multiple Sclerosis, Relapsing-Remitting; Healthy Aging; Neurologic Disorder; Neuromyelitis Optica Spectrum Disorders; Radiologically Isolated Syndrome; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Neurologic Autoimmune Disease; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Omar Al-Louzi, MD; Phone Number: (310) 423-4008; Email: omar.allouzi@cshs.org
• Study Contact Backup: Name: Group Neurology Research; Phone Number: (310)-423-6472; Email: GroupNeurologyMSProgramResearch@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Group Neurology Research; Phone Number: (310)-423-6472; Email: GroupNeurologyMSProgramResearch@cshs.org
      • Contact: Omar Al-Louzi, MD; Phone Number: 310-423-4008; Email: omar.allouzi@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

• 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 Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of disease modifying therapy	Assess the effect modification of various Food and Drug Administration(FDA)-approved disease modifying therapy on disability risk	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	10 years
Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks		10 years

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Omar Al-Louzi, MD, Cedars-Sinai Medical Center; Study Chair: Nancy Sicotte, MD, Cedars-Sinai Medical Center; Study Director: Marwa Kaisey, MD, Cedars-Sinai Medical Center; Study Director: Brooke Guerrero, MD, Cedars-Sinai Medical Center; Study Director: Laura Locke, CRNP, Cedars-Sinai Medical Center; Study Director: Pascal Sati, PhD, Cedars-Sinai Medical Center

Publications and helpful links

Helpful Links

• Cedars-Sinai Clinical Research Website

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): November 11, 2041
• Study Completion (Estimated): November 11, 2041

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Clinically Isolated Syndrome; Radiologically Isolated Syndrome; Multiple Sclerosis, Relapsing-Remitting; Neuromyelitis Optica Spectrum Disorders; Healthy Aging; Myelin oligodendrocyte glycoprotein antibody-associated disease; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive; Neurologic Autoimmune Disease; Neurologic Disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Eye Diseases; Disease Attributes; Disease; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Syndrome; Multiple Sclerosis, Relapsing-Remitting; Nervous System Diseases; Neuromyelitis Optica; Autoimmune Diseases; Autoimmune Diseases of the Nervous System
• Other Study ID Numbers: STUDY00001690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No