Inflammatory and Infectious Diseases of the Nervous System
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|ClinicalTrials.gov Identifier: NCT02435810|
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : August 4, 2021
- 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.
- To learn more about how inflammation and infections hurt the brain and nervous system.
- People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation.
- 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.
|Condition or disease|
The objective of this study is to examine the natural course of infectious and inflammatory diseases of the nervous system, to identify causative or associated pathogens when unknown, and generally to better understand the underlying immunological, genetic and pathophysiologic mechanisms that cause and contribute to these diseases and their ultimate neurological outcomes.
The study population will be patients at least 2 years old with known or suspected infection or inflammation of the nervous system and family members. Subjects will be recruited through referrals to the NIH.
This is a longitudinal case series with standardized research data collection at predefined time points. Subjects will have scheduled visits at the NIH either as an outpatient or an inpatient. The core research evaluations include: a comprehensive history and neurological examination; blood, urine, and saliva collection; neuroimaging; and lumbar puncture.
Follow up visits will be individualized based on clinical needs and results of research evaluations. For some subjects, no additional NIH visits will be necessary
Additionally, we will also enroll subjects with known or suspected infections or inflammation of the nervous system from whom only biological samples collected by outside clinicians will be processed and retained for research analyses. In cases were samples remain from those collected for clinical reasons and the samples are deidentified, the samples may be obtained with a waiver of informed consent.
The study outcomes will primarily be the characterizations of varied inflammatory and infectious nervous system diseases. These characterizations will include: the clinical phenotype and biomarkers.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Natural History Study of Inflammatory and Infectious Diseases of the Nervous System|
|Actual Study Start Date :||May 6, 2015|
|Estimated Primary Completion Date :||November 29, 2025|
|Estimated Study Completion Date :||November 29, 2025|
A family member of a patient with known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided
Patient with known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided
- This is a natural history study of individual cases [ Time Frame: 12 months after the last participant is enrolled. ]To describe the natural history of inflammatory and infectious diseases of the nervous system and to investigate the relative contribution of underlying pathophysiological processes to morbidity, response to treatment and outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435810
|Contact: Amanda M Wiebold||(301) firstname.lastname@example.org|
|Contact: Avindra Nath, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Avindra Nath, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|