Actively Recruiting
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-05
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: \- Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain. It is caused by JC virus. Many people have this virus in their bodies all their life, but it is usually kept in check by their immune system. If the immune system does not work right because of a disease or medication, the virus becomes active and can damage cells in the brain. Not much is known about PML or how it affects the immune system. Researchers want to study people with PML to better understand the natural history of the disease. Objectives: \- To study the natural history of PML. Eligibility: \- Individuals at least 2 years of age who have PML. Design: * Participants will be screened with a physical exam, medical history, and imaging studies. * Participants will have several visits to the National Institutes of Health Clinical Center. There will be an initial visit, monthly visits for the next 6 months, a 12-month visit, and possible visits afterward. * At the initial visit, participants will give blood, urine, and spinal fluid samples. They will also have neurological tests and imaging studies of the brain. * For the next five visits, participants will give blood and urine samples. They will also have neurological tests and imaging studies of the brain. * The 6-month and 12-month visits will repeat the tests from the initial visit. * Other optional procedures include bone marrow samples and skin biopsies. Additional blood tests and imaging studies may be performed. * Treatment will not be provided as part of this study.
CONDITIONS
Official Title
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or confirmed PML
- MRI results compatible with PML
- Ability to participate in all study procedures and follow-up as required
- Age at least 2 years old
- For control patients: impaired immune function and considered at risk for PML
- For healthy volunteers: age at least 18 years old and able to participate in all study procedures and follow-up
You will not qualify if you...
- Significant medical condition making participation impossible or risky as judged by the investigator
- Medical contraindications to MRI such as cardiac pacemakers, infusion pumps, metallic implants or foreign bodies, or non-removable body piercings
- Pregnancy
- Inability to provide informed consent directly or through a legally authorized representative
- Unwillingness to consent to collection and cryopreservation of biological samples
- For healthy volunteers: impaired immune function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Mauricio A Campillay
CONTACT
I
Irene CM Cortese, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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