Inflammatory and Infectious Diseases of the Nervous System
ConditionBrain Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-110
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
About this trial
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.
Eligibility criteria
Qualifiers
fever with nervous system signs or symptoms (excluding delirium)
any neurological symptoms accompanied by cerebrospinal fluid (CSF) with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation including IgG index or presence of oligoclonal bands)
systemic infection or inflammatory disease with neurological involvement
neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)
Disqualifiers
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
Have a family member enrolled on 15-N-0125
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov