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Protocol Details

Natural History of Optic Neuritis

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-N-0104

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 50

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

OCT;
Multiple Sclerosis;
Optic Neuritis;
Magnetic Resonance Imaging (MRI)

Recruitment Keyword(s)

None

Condition(s)

Multiple Sclerosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and StrokeNational Eye Institute

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.

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Eligibility

INCLUSION CRITERIA:

COHORT 1: Unilateral optic neuritis.

- Typical demyelinating optic neuritis based on the best clinical judgment of the investigators.

- Symptom onset within 46 weeks of enrollment OR patients with history of optic neuritis who were followed from symptom onset under a Neuroimmunology Branch natural history or screening protocol.

- For women of childbearing potential, willing to use acceptable forms of contraception (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods (condom or diaphragm) with spermicide or they have undergone surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner) for the study duration.

- Able to provide informed consent.

- Willing and able to participate in all aspects of the trial.

COHORT 2: Healthy volunteers.

- No medical history that would interfere with study result interpretation, in the best clinical judgment of the investigators.

- Age greater than or equal to 18 years and less than or equal to 50 years.

- Able to provide informed consent.

- Willing and able to participate in all aspects of the trial.

EXCLUSION CRITERIA:

-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.


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Citations:

Leaney J, Klistorner A, Arvind H, Graham SL. Dichoptic suppression of mfVEP amplitude: effect of retinal eccentricity and simulated unilateral visual impairment. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6549-55. doi: 10.1167/iovs.10-5769. Epub 2010 Jul 29.

Klistorner A, Arvind H, Garrick R, Yiannikas C, Paine M, Graham SL. Remyelination of optic nerve lesions: spatial and temporal factors. Mult Scler. 2010 Jul;16(7):786-95. doi: 10.1177/1352458510371408. Epub 2010 Jun 7.

Klistorner A, Arvind H, Garrick R, Graham SL, Paine M, Yiannikas C. Interrelationship of optical coherence tomography and multifocal visual-evoked potentials after optic neuritis. Invest Ophthalmol Vis Sci. 2010 May;51(5):2770-7. doi: 10.1167/iovs.09-4577. Epub 2009 Dec 30.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Daniel S. Reich, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 5C103
10 CENTER DR
BETHESDA MD 20814
(301) 496-1801
reichds@ninds.nih.gov

Joan M. Ohayon, C.R.N.P.
National Institutes of Health Clinical Center (CC)
BG 10 RM 5C442
10 CENTER DR
BETHESDA MD 20814
(301) 496-3825
eatonj@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01851434

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