NIH Clinical Center Search the Studies: Study Number, Study Title

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 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Multiple Sclerosis;
Longitudinal Prospective Follow-Up;
Natural History

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.

--Back to Top--

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 OR individuals without known CNS disease.

-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).

-Willing to return to NIH for follow-up visits approximately annually (or every 5 years for non-CNS controls) until the time of autopsy. Note: participants who become too sick to return to NIH will not be removed from the study.

-Willing 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.

-Except for non-CNS controls, simultaneously participating in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.

-Eligible NIH employees and staff may participate.

EXCLUSION CRITERIA:

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


--Back to Top--

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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Daniel S. Reich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
NIHBC 10 - CLINICAL CENTER BG RM 5C103
10 CENTER DR
BETHESDA MD 20892
(301) 496-1801
reichds@ninds.nih.gov

Jenifer E. Dwyer
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 5C429
10 Center Drive
Bethesda, Maryland 20892
(301) 496-3825
jenifer.dwyer@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: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02659956

--Back to Top--