Natural History of Optic Neuritis
Stopped early
Conditions studied: Multiple Sclerosis
In brief
Background: \- Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance imaging (MRI) scans is often greater than that seen in tests given during regular doctor's visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI scans to track changes in the optic nerve after an optic neuritis episode. This approach will help them study the relationship between optic neuritis and MS. Objectives: \- To collect more information about the relationship between optic neuritis and multiple sclerosis. Eligibility: * Individuals between 18 and 50 years of age who have new optic neuritis. * Individuals between 18 and 50 years of age who have new symptoms of MS other than optic neuritis. * Healthy volunteers between 18 and 50 years of age. Design: * Participants will be screened with a physical exam and medical history. They may provide blood or urine samples. * Participants with optic neuritis or other MS symptoms will have a baseline study visit. They will have a physical exam and full eye exam. To look for signs of MS, they will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves. * After the first visit, participants will have steroid treatment for 5 days for the optic neuritis. * Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits. * Healthy volunteers will have a baseline study visit. They will have a physical exam and full eye exam. They will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves. * Healthy volunteers will have additional study visits 2 and 11 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits.
Key facts
- Study ID
- NCT01851434
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 8
- Starts
- 2013-03-20
- Expected to finish
- 2017-10-26
- Last updated by the study team
- 2022-09-29
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- History of signs or symptoms suspicious for MS, in the best clinical judgment of the investigators.
- Pateints-Disease-modifying therapy for MS prior to the onset of the current episode of optic neuritis (excludes oral or intravenous glucocorticoids: Healthy Volunteers - Previous or current use of disease-modifying therapy for MS (excluding oral or intravenous glucocorticoids.
- Previous history of clinical optic neuritis or a systemic disease associated with optic neuritis (e.g. sarcoidosis, lymphoma).
- Current or prior optic neuropathy (e.g. trauma, ischemia, glaucoma, optic nerve drusen).
- Previous history of a retinal disease (e.g. diabetic retinopathy, retinal drusen) other than uveitis.
- Previous history of an ophthalmic disease that in the best judgment of the investigator could affect ophthalmic imaging results.
- Previous history of a systemic disease that may mimic MS (e.g. neurosyphilis, neurosarcoidosis, CNS ymphoma, Si(SqrRoot)(Delta)gren s syndrome).
- Previous history of a systemic disease that in the best judgment of the investigator could confound study outcome.
- Current use of a TNF-alpha inhibitor (e.g. etanercept).
- Habitual use of illicit drugs that in the best judgment of the investigators could confound study outcome.
- Pregnant or breast-feeding.
- Unwilling to co-enroll on a Neuroimmunology Branch natural history or screening protocol currently 89-N-0045.
- Contraindication to MRI scanning.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
- University of Utah — Salt Lake City, Utah, United States
- Hadassah Hospital/Hebrew University Medical Center — Jerusalem, Israel
Full record on ClinicalTrials.gov
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