Investigating risk factors for disability progression in Multiple Sclerosis
Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders
This study is trying to find out what factors might make disability get worse in people with Multiple Sclerosis by looking at their medical history and MRI scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05204459 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify risk factors that contribute to disability progression in Multiple Sclerosis and related disorders. Participants will undergo a comprehensive screening process at Cedars-Sinai Medical Center, where their medical and MRI records will be reviewed to determine eligibility. The main research will involve collecting demographic data, medical history, and conducting quantitative disability assessments, alongside optional sub-studies that may include blood draws and additional MRI scans. The study will utilize historical and ongoing MRI data to predict changes in disability measures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of Multiple Sclerosis, Clinically Isolated Syndrome, or related neurological disorders.
Not a fit: Patients with contraindications to MRI or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of disability progression in patients with Multiple Sclerosis, allowing for better management and treatment strategies.
How similar studies have performed: Other studies have shown promise in using MRI and biomarker data to assess disability progression in Multiple Sclerosis, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Omar Al-Louzi, MD — Cedars-Sinai Medical Center
- Study coordinator: Omar Al-Louzi, MD
- Email: omar.allouzi@cshs.org
- Phone: (310) 423-4008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.