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Protocol Details

The Pathological Basis of MRI Signal Changes in Multiple Sclerosis: A Longitudinal In Vivo-to-Postmortem Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-N-0055

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;
Longitudinal Prospective Follow-Up

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 Stroke

Background:

Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and spinal cord). This leads to increased physical disability over time. The disease is lifelong once it begins. Researchers want to learn more about MS s stages and follow them until a person s death.

Objective:

To understand how the physical and clinical signs of MS relate to its changes over time.

Eligibility:

Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like MS.

Design:

Participants will have a medical history and a complete neurological exam. They may have timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test.

Participants will have multi-day visits about once a year.

Participants will have blood drawn.

Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm vein. During the MRI, participants will lie on a table that slides in and out of a metal cylinder.

Participants will have the thickness of their retina measured using optical coherence tomography. A camera on top of a table uses lasers. Participants will look through a lens and follow instructions. Eye drops may be used to dilate the pupils.

Participants will chew on a piece of sterile cotton for 1 minute to collect saliva.

Participants agree to have an autopsy at the time of their death and to donate some of their organs to research, such as the brain and spinal cord.

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Eligibility

INCLUSION CRITERIA:

-Diagnosis of MS according to consensus criteria at the time of enrollment OR diagnosis of a disease that shares clinical, imaging, or biological features with MS.

-Age greater than or equal to 18.

-Able to participate in study procedures and provide high-quality clinical research data (for example, prior MRI scans show ability to tolerate the MRI scan with minimal motion artifact).

-Agrees to return to NIH for follow-up visits approximately annually until the time of autopsy. Note: participants who become too sick to return to NIH will not be removed from the study.

-Agrees to undergo autopsy with donation of at least the brain, spinal cord, and retinas.

-Able to provide informed consent at the time of initial study enrollment and willing to appoint a Durable Power of Attorney (DPA) if an advanced directive is not already in place.

-Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.

EXCLUSION CRITERIA:

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


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Citations:

Absinta M, Nair G, Filippi M, Ray-Chaudhury A, Reyes-Mantilla MI, Pardo CA, Reich DS. Postmortem magnetic resonance imaging to guide the pathologic cut: individualized, 3-dimensionally printed cutting boxes for fixed brains. J Neuropathol Exp Neurol. 2014 Aug;73(8):780-8. doi: 10.1097/NEN.0000000000000096.

Absinta M, Vuolo L, Rao A, Nair G, Sati P, Cortese IC, Ohayon J, Fenton K, Reyes-Mantilla MI, Maric D, Calabresi PA, Butman JA, Pardo CA, Reich DS. Gadolinium-based MRI characterization of leptomeningeal inflammation in multiple sclerosis. Neurology. 2015 Jul 7;85(1):18-28. doi: 10.1212/WNL.0000000000001587. Epub 2015 Apr 17.

Maggi P, Macri SM, Gait(SqrRoot)(Degree)n MI, Leibovitch E, Wholer JE, Knight HL, Ellis M, Wu T, Silva AC, Massacesi L, Jacobson S, Westmoreland S, Reich DS. The formation of inflammatory demyelinated lesions in cerebral white matter. Ann Neurol. 2014 Oct;76(4):594-608. doi: 10.1002/ana.24242. Epub 2014 Aug 21.

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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:

NCT02659956

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