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Protocol Details

A Traveling Subject Study of Replicability in Conventional and Advanced MRI MS Biomarkers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-N-0081

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Multiple Sclerosis;
Non-contrast 3T Brain Scan;
Differences Between MRI Scanners

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:

Magnetic resonance imaging (MRI) scans take detailed pictures of the body. These pictures can tell doctors about disease activity in multiple sclerosis (MS). More advanced MRI techniques are better at showing how the disease is progressing. However, they are used only in research settings. Researchers want to start using these newer approaches in order to speed progress in MS research.

Objective:

To study the differences between MRI scanners for assessing people with MS.

Eligibility:

People ages 18 to 60 years of age who have MS (recruiting). One (1) Healthy volunteer is also needed (healthy volunteer enrollment complete).

Design:

Participants will be screened with their medical history and a checklist to see if they are eligible.

Participants will have 4 MRIs at 4 separate sites within 3 months. One MRI will be at NIH. The others will be at sites in Philadelphia, Baltimore, and Boston.

Before each MRI, participants will have a physical exam. Women who arew having periods will have a blood or urine pregnancy test.

Participants will lie on a table. A coil will be placed around (but not touching) the head. The table will slowly slide the participant into the machine. Within the machine, radio waves will be transmitted and made into pictures of the body.

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Eligibility

INCLUSION CRITERIA:

For MS patients:

-Clinically and radiologically stable MS as per the 2017 McDonald criteria

-Ambulatory

-Able to travel

-18 to 60 years of age

-Fluent in English

-Able to give informed consent

For the healthy control subject:

-Ambulatory

-Able to travel

-18 years or older

-Fluent in English

EXCLUSION CRITERIA:

For MS patients:

-Gadolinium-enhancing lesions (in the 6 months before recruitment)

-Evidence of new lesions (in past 6 months before recruitment)

-Not ambulatory

-In clinical relapse

-Major comorbidities

-Steroids within 30 days of enrollment

-Changes to disease modifying therapies (DMTs) within the 6 months prior to enrollment

-Pregnancy

For the healthy control subject:

-History of neurological disease

-Pregnancy


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Frances C. Andrada, C.R.N.P.
National Institutes of Health Clinical Center (CC)
BG 10 RM 5C101
10 CENTER DR
BETHESDA MD 20814
(301) 496-0064
andradaf@mail.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

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