Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2021-11-11
2041-11-11
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RRMS, SPMS, PPMS, CIS or RIS
Multiple Sclerosis (relapsing-remitting, primary or secondary progressive forms), clinically isolated syndrome, or radiologically isolated syndrome
No interventions assigned to this group
NMOSD
Neuromyelitis optica spectrum disorders
No interventions assigned to this group
MOGAD
Myelin oligodendrocyte glycoprotein antibody disorders
No interventions assigned to this group
Neurological disorder other than MSRD
Neurological disorders due to neurodegenerative, vascular, or headache conditions that are not related to multiple sclerosis or related disorders.
No interventions assigned to this group
Healthy controls
Healthy controls with no known neurological conditions
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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 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).
18 Years
ALL
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Omar Al-Louzi
Staff Physician; Director, Visual Outcomes Lab
Principal Investigators
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Omar Al-Louzi, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Marwa Kaisey, MD
Role: STUDY_DIRECTOR
Cedars-Sinai Medical Center
Brooke Guerrero, MD
Role: STUDY_DIRECTOR
Cedars-Sinai Medical Center
Laura Locke, CRNP
Role: STUDY_DIRECTOR
Cedars-Sinai Medical Center
Pascal Sati, PhD
Role: STUDY_DIRECTOR
Cedars-Sinai Medical Center
Nancy Sicotte, MD
Role: STUDY_CHAIR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Cedars-Sinai Clinical Research Website
Other Identifiers
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STUDY00001690
Identifier Type: -
Identifier Source: org_study_id
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