Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

This study is enrolling participants by invitation only.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Igor Koralnik, Beth Israel Deaconess Medical Center Identifier:
First received: May 26, 2010
Last updated: January 19, 2016
Last verified: January 2016
This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy (PML). We will focus on the role of inflammation in PML, and define prognostic markers of disease evolution.

Progressive Multifocal Leukoencephalopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Inflammation in PML

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Biospecimen Retention:   Samples With DNA
Blood, Urine, CSF if needed for clinical management.

Estimated Enrollment: 180
Study Start Date: June 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
These are subjects who have confirmed PML.
These are subjects who do not have PML. They may be healthy or immune compromised due to Cancer, Transplant, or HIV.

Detailed Description:
To determine precisely what are the host or viral factors that may predict a favorable outcome for PML patients and the role of inflammation in preventing JCV from causing brain disease. One of the goals of this study is to help establish non-invasive markers of PML evolution by studying the brain metabolism in PML lesions using Magnetic Resonance Imaging (MRI), Magnetic Spectroscopy (MRS) and other advanced imaging modalities.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

PML patients of 18 years of age or older in the Boston area will be included in this study.

The control groups will include HIV+ and HIV- individuals who need to have a lumbar puncture for their clinical management.


Inclusion Criteria:

  • PML patients of 18 years of age or older will be included in this study.

Exclusion Criteria:

  1. Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)
  2. Presence of confounding neurological disorder such as brain neoplasm etc.

In addition patients with a contraindication to MRI examination will be excluded from study. Contraindications to the MRI examination include:

  1. Medically unstable or hematological, renal, or hepatic dysfunction.
  2. Cardiac pacemaker
  3. Internal clips,
  4. Metal implants, or external clips with 10 mm of the head.
  5. Metal in the eyes.
  6. Pregnant
  7. Claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01132053

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
Principal Investigator: Igor J Koralnik, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Responsible Party: Igor Koralnik, principal investigator, Beth Israel Deaconess Medical Center Identifier: NCT01132053     History of Changes
Other Study ID Numbers: 2004-P-000089  NS 047029 
Study First Received: May 26, 2010
Last Updated: January 19, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Additional relevant MeSH terms:
Leukoencephalopathy, Progressive Multifocal
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
DNA Virus Infections
Demyelinating Diseases
Encephalitis, Viral
Infectious Encephalitis
Nervous System Diseases
Polyomavirus Infections
Slow Virus Diseases
Virus Diseases processed this record on May 26, 2016