Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02435810
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2015-05-01
Brief Title:
Inflammatory and Infectious Diseases of the Nervous System
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History Study of Inflammatory and Infectious Diseases of the Nervous System
Status:
RECRUITING
Status Verified Date:
2024-09-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
- 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-N-0125 | None | None | None |