RECRUITING

Inflammatory and Infectious Diseases of the Nervous System

Conditions

Brain Disease Neuroinflammation Infections Natural History

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-05-06

Study Completion:2025-11-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02435810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 110 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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	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 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. 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 1. Not willing to consent for collection of biological samples or their cryopreservation

Inclusion Criteria

Exclusion Criteria

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
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

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

Contacts and Locations

Study Contact

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

Principal Investigator

Avindra Nath, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Avindra Nath, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-05-06

Study Completion Date2025-11-29

Study Record Updates

Study Start Date2015-05-06

Study Completion Date2025-11-29

Terms related to this study

Keywords Provided by Researchers

Neuroinflammation
Infections
Natural History

Additional Relevant MeSH Terms

Brain Disease