Understanding how infections and inflammation affect the brain and nervous system

Natural History Study of Inflammatory and Infectious Diseases of the Nervous System

This study is trying to understand how infections and inflammation impact the brain and nervous system by looking at samples and health information from people with these conditions.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 2 Years to 110 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02435810 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the natural history of infectious and inflammatory diseases affecting the nervous system. Researchers will collect and analyze biological samples from participants with known or suspected conditions, including blood, urine, and saliva, as well as conduct neurological examinations and neuroimaging. The study will involve both outpatient and inpatient visits to the NIH Clinical Center, with follow-up tailored to individual clinical needs. The goal is to identify pathogens and understand the underlying mechanisms contributing to these diseases.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2 years and older with a diagnosis or suspected diagnosis of nervous system infection or inflammation.

Not a fit: Patients without any signs or symptoms of nervous system infection or inflammation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tests and treatments for infections and inflammation of the nervous system.

How similar studies have performed: Other studies have shown success in understanding neuroinflammatory conditions, but this specific approach to longitudinal data collection is relatively novel.

Eligibility criteria

* INCLUSION CRITERIA:

At the time of enrollment, participants will:

1. 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:

   1. fever with nervous system signs or symptoms (excluding delirium)
   2. 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)
   3. systemic infection or inflammatory disease with neurological involvement
   4. neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)
   5. clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation
   6. history of infection or inflammatory process of the nervous system
2. Be willing to participate in the protocol s procedures, unless clinically contraindicated
3. Be willing to provide informed consent, either directly or via appointed legally authorized representative
4. Be willing to consent for collection of clinical data or biological samples or their cryopreservation
5. Be at least 2 years old

INCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:

At the time of enrollment, participants will:

1. 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:

   1. fever with nervous system signs or symptoms (excluding delirium)
   2. 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)
   3. systemic infection or inflammatory disease with neurological involvement
   4. neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)
   5. clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation
   6. history of infection or inflammatory process of nervous system
2. Be willing to provide informed consent, either directly or via appointed legally authorized representative
3. Be willing to consent for collection of clinical data or biological samples or their cryopreservation
4. Be at least 2 years old

EXCLUSION CRITERIA:

At the time of enrollment, participants will:

1. 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)
2. 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
3. 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:

1\. 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:

1. Have a family member enrolled on 15-N-0125
2. Be at least 2 years old
3. Be able to provide informed consent and comply with study procedures

EXCLUSION CRITERIA FOR FAMILY MEMBERS:

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

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Avindra Nath, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Ladifatou N Fouanta, R.N.

Conditions: Brain Disease, Neuroinflammation, Infections, Natural History