Inflammatory and Infectious Diseases of the Nervous System
Recruiting now
Conditions studied: Brain Disease
In brief
Background: \- Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments. Objective: \- To learn more about how inflammation and infections hurt the brain and nervous system. Eligibility: \- People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation. Design: * For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed. * Other participants will have several visits to NIH. Children may not have all these tests. * Participants will have: * Medical history. * Physical and neurological exam. * Blood and urine samples collected. * Saliva collected. They will chew on a piece of sterile cotton for one minute. * Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein. * Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed. * Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.
Key facts
- Study ID
- NCT02435810
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 1000
- Starts
- 2015-05-06
- Expected to finish
- 2026-11-29
- Last updated by the study team
- 2026-08-07
Who can join
Age: 2 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- At the time of enrollment, participants will:
- Not have a clinically significant medical condition that, in the best judgment of the investigators, may expose the patient to undue risk of harm or prevent the patient from completing the study (examples include, but are not limited to, ischemic cardiomyopathy, clotting disorder, brittle diabetes)
- Not have an acute or unstable medical condition that, in the best judgement of the investigator, would be difficult to handle at the NIH Clinical Center
- Not have a clearly-established diagnosis of well-characterized disease entity with validated treatment algorithms for which proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge
- EXCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:
- At the time of enrollment, participants will not have:
- A clearly-established diagnosis of well-characterized disease entity with validated treatment algorithms for which proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge
- INCLUSION CRITERIA FOR FAMILY MEMBERS:
- Have a family member enrolled on 15-N-0125
- Be at least 2 years old
- Be able to provide informed consent and comply with study procedures
- EXCLUSION CRITERIA FOR FAMILY MEMBERS:
- Not willing to consent for collection of biological samples or their cryopreservation
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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