Scientists watch brain diseases unfold to find better ways to diagnose and treat
NCT ID NCT02435810
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 8 times
Summary
This study aims to learn more about how infections and inflammation harm the brain and nerves. Researchers will collect samples and perform tests on people aged 2 and older who have or may have these conditions. The goal is to better understand these diseases so that better tests and treatments can be developed in the future. No new treatments are being tested in this study.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2015
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will have a known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided.
- Ages
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2 to 110 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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