Inflammatory and Infectious Diseases of the Nervous System

NCT02435810 | Recruiting

• 2 other identifiers: 15012515-N-0125
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Disease

Keywords

Neuroinflammation; Infections; Natural History

Outcome Measures

Primary Outcomes (1)

• This is a natural history study of individual cases

  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.

  12 months after the last participant is enrolled.

Study Arms (2)

Family Member

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

Patient with known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided

Eligibility Criteria

• Age: 2 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will have a known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided.

You may qualify if:

• At the time of enrollment, participants will:
• Have a known or suspected infection or inflammation of the nervous system or post infection sequelae based on clinical or imaging data provided by the referral facility. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:
• 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)
• clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation
• history of infection or inflammatory process of the nervous system
• Be willing to participate in the protocol s procedures, unless clinically contraindicated
• Be willing to provide informed consent, either directly or via appointed legally authorized representative
• Be willing to consent for collection of clinical data or biological samples or their cryopreservation
• Be at least 2 years old
• At the time of enrollment, participants will:
• Have a known or suspected infection or inflammation of the nervous system or post infection sequelae based on clinical or imaging data provided by the referral facility. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:
• fever with nervous system signs or symptoms (excluding delirium)

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
• 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
• 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
• \. Not willing to consent for collection of biological samples or their cryopreservation

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Diseases; Neuroinflammatory Diseases; Infections

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Avindra Nath, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ladifatou N Fouanta, R.N.

CONTACT

(301) 529-6340; ladifatou.fouanta@nih.gov

Avindra Nath, M.D.

CONTACT

(301) 496-1561; natha@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 6, 2015
• Study Start: May 6, 2015
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)