Pathological Basis of MRI Signal Changes in Multiple Sclerosis
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study ID
- NCT02659956
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Apr 7, 2016
- Status verified
- Jun 2026
- Primary completion
- Feb 26, 2080
- Completion
- Feb 26, 2080
Study Design
- Enrollment
- 250 participants (estimated)
Arms
- Arm: Individuals without known CNS diseaseFamily members of patient participants
- Arm: Patient controlsA target population of 100 patient controls will also be enrolled. These individuals will have diseases that share clinical, imaging, or biological features with MS.
- Arm: Patients with multiple sclerosisUp to 250 adults (age \>= 18) with MS, diagnosed by applicable consensus criteria and by the best judgment of the investigators at the time of enrollment.
Primary Outcome Measure
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ("lesions") in the brain, spinal cord, and retinas. [ Time Frame: annual visits ]
Central Contacts
- Jenifer E Dwyer(301) 496-3825
- Daniel S Reich, M.D.(301) 496-1801
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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