ClinicalTrials.gg
RecruitingNCT02435810Updated Nov 9, 2026

Inflammatory and Infectious Diseases of the Nervous System

An observational study in Brain Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 2 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational

From the registry’s dates

  • Started May 2015; still recruiting 11 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
2 Years to 110 Years
Sex
All
01

Study 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.
Read the detailed description

Objective:

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.

Study Population:

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. Participants will be recruited through referrals to the NIH.

Design:

This is a longitudinal case series with standardized research data collection at predefined time points. Participants 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 collection; neuroimaging; and lumbar puncture. Follow up visits will be individualized based on clinical needs and results of research evaluations. For some participants, no additional NIH visits will be necessary.

Additionally, we will also enroll participants 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.

Outcome Measures:

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.

02

Conditions studied

  • Brain Disease

Keywords

  • Neuroinflammation
  • Infections
  • Natural History
03

In context

Brain Diseases

502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 149 across 144 observational studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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
  3. Be willing to provide , 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 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

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: 12 months after the last participant is enrolled.

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Publications

  • Benjamin R, Qi YA, Hao Y, DeMarino C, Darko S, Cortese I, Reich DS, Gaitan MI, Jacobson S, Billioux BJ, Smith B, Nath A. Endothelial Cell Proteins as Biomarkers in Susac Syndrome. Ann Clin Transl Neurol. 2026 Aug 13. doi: 10.1002/acn3.70508. Online ahead of print. PubMed 42593056 ↗

Individual participant data

Plan to share: No

09

Updates

3 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
3 updates, last Oct 16, 2026
Show all 3 updates
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 5, 2026
    Minor edits only
    + 1 other change: verification date
  3. Oct 1, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02435810
Responsible party
Sponsor
First posted
May 6, 2015
Start date
May 6, 2015
Primary completion
Nov 29, 2026 (estimated)
Completion
Nov 29, 2026 (estimated)
Last update
Nov 9, 2026

Study contacts

Ladifatou N Fouanta, R.N.
Contact
ladifatou.fouanta@nih.gov
(301) 529-6340
Avindra Nath, M.D.
Contact
natha@mail.nih.gov
(301) 496-1561
Avindra Nath, M.D.
principal investigator · National Institute of Neurological Disorders and Stroke (NINDS)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion