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Natural History of Optic Neuritis

NCT01851434 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2022-09-29

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Daniel S Reich, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-20
Primary Completion
2014-09-05
Completion
2017-10-26

Countries

  • United States
  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851434 on ClinicalTrials.gov