[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05204459":3,"trial-entities:NCT05204459":121,"trial-summary:NCT05204459":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":30,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":39,"secondary_outcomes":44,"sex":53,"minimum_age":54,"maximum_age":33,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":71,"locations":74,"central_contacts":93,"overall_officials":97,"references":112,"see_also_links":117},"NCT05204459","STUDY00001690","MS-ResearchBiomarkerS","Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders","RECRUITING","2041-11-11","2024-02","2024-02-06","2021-11-11","Cedars-Sinai Medical Center","OTHER",false,"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\u002For spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.","Screening:\n\nProspective 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.\n\nMain Research Study:\n\nThe following items will be collected as part of the main research study:\n\n* Demographic data and medical history, including medications, family, and social history\n* Complete a series of quantitative disability assessments,\n* Collection of historic MRI data obtained as part of standard of care\n\nOptional Sub-study:\n\nParticipants 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:\n\n* Research blood draw\n* Additional blood sample for a genetic and\u002For stem cell sub-study\n* Visual assessment\n* Research MRI\n\nHow 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.\n\nCompensation 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.",[19,20,21,22,23,24,25,26,27,28,29],"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",[19,20,21,22,23,24,25,31,27,28,29],"Myelin oligodendrocyte glycoprotein antibody-associated disease","OBSERVATIONAL",null,[],{"count":36,"type":37},1000,"ESTIMATED",[],[40],{"measure":41,"description":42,"timeFrame":43},"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\u002For thoracic spinal cord) can predict quantitative disability progression risk","10 years",[45,48,51],{"measure":46,"description":47,"timeFrame":43},"Effect of disease modifying therapy","Assess the effect modification of various Food and Drug Administration(FDA)-approved disease modifying therapy on disability risk",{"measure":49,"description":50,"timeFrame":43},"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",{"measure":52,"timeFrame":43},"Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks","ALL","18 Years",true,{"inclusion":57,"exclusion":66,"raw_text":70},[58,59,60,61,62,63,64,65],"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.",[67,68,69],"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\u002FOCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).","Inclusion Criteria:\n\n* Subjects who meet any one of the following diagnostic criteria:\n\n  * Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.\n  * Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.\n  * Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.\n  * Diagnosis of neurological disorders other than MSRD.\n  * Healthy volunteer.\n* Age ≥18.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* 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).\n* 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.\n* 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\u002FOCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":90},"Los Angeles","California","90048","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Omar Al-Louzi, MD","CONTACT","310-423-4008","omar.allouzi@cshs.org",{"name":87,"role":83,"phone":88,"email":89},"Group Neurology Research","(310)-423-6472","GroupNeurologyMSProgramResearch@cshs.org",{"lat":91,"lon":92},34.05223,-118.24368,[94,96],{"name":82,"role":83,"phone":95,"email":85},"(310) 423-4008",{"name":87,"role":83,"phone":88,"email":89},[98,100,103,105,107,109],{"name":82,"affiliation":13,"role":99},"PRINCIPAL_INVESTIGATOR",{"name":101,"affiliation":13,"role":102},"Marwa Kaisey, MD","STUDY_DIRECTOR",{"name":104,"affiliation":13,"role":102},"Brooke Guerrero, MD",{"name":106,"affiliation":13,"role":102},"Laura Locke, CRNP",{"name":108,"affiliation":13,"role":102},"Pascal Sati, PhD",{"name":110,"affiliation":13,"role":111},"Nancy Sicotte, MD","STUDY_CHAIR",[113],{"pmid":114,"type":115,"citation":116},"41841206","DERIVED","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\u002Facn3.70352. doi: 10.1002\u002Facn3.70352. Online ahead of print.",[118],{"label":119,"url":120},"Cedars-Sinai Clinical Research Website","https:\u002F\u002Fwww.cedars-sinai.org\u002Fprograms\u002Fneurology-neurosurgery\u002Fclinical-trials\u002Fms-research-biomarkers.html",{"nct_id":4,"conditions":122,"biomarkers":128},[123,124,29,19,31,125,126,127],"Autoimmune Nervous System Disorder","Clinically isolated syndrome","Nervous System Disorder","Neuromyelitis Optica","Radiologically isolated syndrome",[],{"nct_id":4,"found":55,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an observational study with a planned enrollment of 1000 participants. It is not a treatment study, but rather aims to collect information.","completed","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.","The primary endpoint for identifying risk factors for disability progression is measured at 10 years.",99,"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.","Not stated in the trial record.",[],"v2"]