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Age: 2Years - 120Years
All Genders
Healthy Volunteers
ID01730131

Study to Understand the Course and Immune Effects of Progressive Multifocal Leukoencephalopathy PML

Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-08-06

700

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Progressive multifocal leukoencephalopathy PML is a serious brain infection caused by the JC virus, which usually remains inactive in most people but can become active if the immune system is weakened due to disease or medication. The study aims to understand the natural history and effects of PML on the immune system by following patients with PML and individuals at risk, alongside healthy volunteers. Participants include those with suspected or confirmed PML, individuals with impaired immune function who may be at risk for PML, and healthy volunteers. The study involves multiple visits including an initial visit, monthly visits for six months, a 12-month visit, and possible additional visits. During these visits, participants undergo physical exams, neurological tests, brain imaging, and provide blood, urine, and spinal fluid samples. Optional procedures may include bone marrow samples and skin biopsies. No treatment is provided as part of the study. Participants will be monitored over time with detailed clinical and imaging assessments to collect data on the diseases course and immune response. The research includes evaluating viral behavior, immune markers, and genetic factors. The main measurement focuses on characterizing patients at one year after enrollment, with follow-up assessments to track progression. This long-term observation helps to develop tools for earlier diagnosis and better management of PML.

CONDITIONS

Brief Title

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

Who Can Participate

Age: 2Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected or confirmed PML
  • MRI results compatible with PML
  • Ability to participate in study visits and follow-up
  • Age 2 years or older
  • Impaired immune function and at risk for PML (for control group)
  • Healthy volunteers aged 18 years or older (for healthy control group)
Not Eligible

You will not qualify if you...

  • Significant medical condition making participation unsafe or impossible
  • Medical devices or implants preventing MRI
  • Pregnancy
  • Unable to provide informed consent or lack of legally authorized representative
  • Unwillingness to provide biological samples or consent to their cryopreservation
  • Impaired immune function (for healthy volunteer group)

Research Team

M

Mauricio A Campillay

I

Irene CM Cortese, M.D.

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