Cerebrospinal Fluid Collection and Repository Storage



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:2 - 100
Updated:1/17/2019
Start Date:May 22, 2013
End Date:April 30, 2063
Contact:Amanda M Wiebold
Email:amanda.wiebold@nih.gov
Phone:(301) 594-5194

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Background:

- Cerebrospinal fluid (CSF) is the liquid around the brain and spinal cord. Many diseases can
only be diagnosed by examining the CSF. A lumbar puncture is used to collect and test CSF.
Once someone is already having a lumbar puncture, a small extra amount of CSF can be
collected at the same time. This fluid can be used to study brain, nerve, and related health
issues. Researchers want to collect CSF and blood samples from people who are scheduled to
have a lumbar puncture.

Objectives:

- To collect cerebrospinal fluid and blood samples from individuals who are having a lumbar
puncture.

Eligibility:

- Individuals between 2 and 100 years of age who are scheduled to have a lumbar puncture for
clinical or research purposes.

Design:

- Participants will have a lumbar puncture for clinical or research purposes.

- During the procedure, an additional sample of CSF will be collected. They will also
provide a blood sample, if one is not taken at the time of the procedure.

- Treatment will not be provided as part of this study.

In this study we are planning to establish a repository of cerebrospinal fluid (CSF), serum,
and plasma. We are planning to collect a small amount of additional CSF and blood on subjects
who are already going to have a lumbar puncture as part of their research or clinical care at
the National Institutes of Health (NIH). This will allow us to study whether there is an
association between neurological diseases and biomarkers, help identify novel pathogens
infecting the central nervous system, and better enable us to understand the immune response
to infections under future protocols. CSF and blood as well as clinical data associated with
the samples will be stored securely.

- SUBJECT INCLUSION CRITERIA:

- Subjects between the ages of 2 years and 100 years identified to undergo LP for
research or for clinical care purposes at the NIH Clinical Center.

SUBJECT EXCLUSION CRITERIA:

-Subjects with the inability to provide informed consent either directly or via a legally
authorized representative.

Inclusion of Vulnerable Subjects - Research Involving Adults Who Are Or May Be Unable To
Consent:

-The risks to all subjects involved in this research project are no more than minimal risk
as we are only collecting additional CSF and plasma during a LP procedure that is already
being performed under a separate research protocol or as a clinically indicated procedure.
At the time of the LP it will already be determined if the subject is able to give informed
consent and if not a legally authorized representative will have been appointed who will
decide if the additional CSF and plasma can be obtained from the individual.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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mi
from
Bethesda, MD
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