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Cerebrospinal Fluid Collection and Repository Storage

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Terminated

Conditions

Nervous System Diseases

Study type

Observational

Funder types

NIH

Identifiers

NCT01862107
130140
13-N-0140

Details and patient eligibility

About

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.

Full description

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.

Enrollment

51 patients

Sex

All

Ages

2 to 110 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

  • SUBJECT INCLUSION CRITERIA:
  • Subjects (patients and healthy volunteers) 2 years of age and older identified to undergo LP for research or for clinical care purposes at the NIH Clinical Center.

SUBJECT EXCLUSION CRITERIA:

-Subjects (patients and healthy volunteers) 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.

Trial design

51 participants in 2 patient groups

Healthy Volunteer
Description:
Any healthy volunteer getting a lumbar puncture done for either clinical care or research purposes.
Patient
Description:
Any patient getting a lumbar puncture done for either clinical care or research purposes.

Trial contacts and locations

1

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Central trial contact

Avindra Nath, M.D.; Amanda M Wiebold

Data sourced from clinicaltrials.gov

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