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Protocol Details

Thematic Studies of Multiple Sclerosis and Related Diseases

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0158

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Multiple Sclerosis;
Clinically Isolated Syndrome;
CNS Inflammatory Demyellnation;
Radiologically Isolated Syndrome

Recruitment Keyword(s)

None

Condition(s)

Neurologic Disorders;
Healthy Volunteers;
Multiple Sclerosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

- Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI pictures are taken. They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide.

Objectives:

- To collect data that will help researchers better understand MS and related diseases.

Eligibility:

- Adults 18 and older with MS or MRI findings that appear similar to MS, or with other neurological diseases that may look or act like MS.

- Healthy adult volunteers.

Design:

- Participants will be screened with a review of their medical records.

- Participants will have a baseline visit. It will include a physical exam, medical history, and neurological exam. They may have blood tests.

- The study will last indefinitely.

- Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle will be used to guide a thin plastic tube into an arm vein.

- Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a needle inserted between back bones will remove fluid.

- Participants may give saliva samples and have an eye exam.

- Participants may have evoked potential tests. These measure how the nervous system responds to different types of stimulation. Participants may sit in front of a TV and watch pictures on the screen. Or they may wear earphones that make a clicking noise or static. Or they may get a small electrical shock that may tingle and cause a hand or foot twitch.

- Participants may have tests of strength, spasticity, sensations, balance, and/or walking.

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Eligibility

INCLUSION CRITERIA:

<TAB>

-One or more of the following:

--Diagnosis of MS, clinically isolated syndrome, or radiologically isolated syndrome.

--Presentation with clinical or neuroimaging findings that, in the best judgment of the investigators, are possibly consistent with central nervous system inflammatory demyelination.

--Healthy volunteer.

-Age greater than or equal to18.

-Able to participate in study procedures and provide high-quality clinical research data, in the best judgment of the investigators.

-Interest of the study investigators in performing one or more procedures under one or more of the substudies.

EXCLUSION CRITERIA:

<TAB>

-Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.

-Inability to provide informed consent.


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Citations:

Gait(SqrRoot)(Degree)n MI, Shea CD, Evangelou IE, Stone RD, Fenton KM, Bielekova B, Massacesi L, Reich DS. Evolution of the blood-brain barrier in newly forming multiple sclerosis lesions. Ann Neurol. 2011 Jul;70(1):22-9. doi: 10.1002/ana.22472. Epub 2011 Jun 27.

Jones BC, Nair G, Shea CD, Crainiceanu CM, Cortese IC, Reich DS. Quantification of multiple-sclerosis-related brain atrophy in two heterogeneous MRI datasets using mixed-effects modeling. Neuroimage Clin. 2013 Aug 13;3:171-9. doi: 10.1016/j.nicl.2013.08.001. eCollection 2013.

McFarland HF, Frank JA, Albert PS, Smith ME, Martin R, Harris JO, Patronas N, Maloni H, McFarlin DE. Using gadolinium-enhanced magnetic resonance imaging lesions to monitor disease activity in multiple sclerosis. Ann Neurol. 1992 Dec;32(6):758-66.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Daniel S. Reich, M.D.
National Institutes of Health Clinical Center (CC)



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:

NCT02504840

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