Brain DiseaseNCT02435810
Inflammatory and Infectious Diseases of the Nervous System
An observational study of Brain Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 110 years
- Conditions the study is for
- Brain Disease
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2015to 29 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will have a known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided.
Who may be able to join
- 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)
Show all 27Show fewer
- 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
- INCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:
- 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 nervous system
- 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
- 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
Who cannot join
- 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
- 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
- 1. Not willing to consent for collection of biological samples or their cryopreservation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Natural History Study of Inflammatory and Infectious Diseases of the Nervous System
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.
Read more
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.
- Conditions
- Brain Disease
- Keywords
- Neuroinflammation, Infections, Natural History
- Medical subject headings
- Brain Diseases, Neuroinflammatory Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the last participant is enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start6 May 2015
- Primary completion29 Nov 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Avindra Nath, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435810
- Sponsor's protocol ID
- 150125
- Other IDs
- 15-N-0125
- Status last verified
- 9 Oct 2026
- First submitted
- 1 May 2015
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study of Inflammatory and Infectious Diseases of the Nervous System
- ClinicalTrials.gov ID
- NCT02435810
- Acronym / sponsor ID
- 150125
- Conditions
- Brain Disease
- Keywords
- Neuroinflammation, Infections, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 6 May 2015 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will have a known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided.
Key inclusion criteria (27 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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
- 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
- 1. Not willing to consent for collection of biological samples or their cryopreservation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 42593056Benjamin 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Brain Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avindra Nath, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ladifatou N Fouanta, R.N. ((301) 529-6340, ladifatou.fouanta@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This is a natural history study of individual cases (time frame: 12 months after the last participant is enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.