Cerebrospinal Fluid Collection and Repository Storage

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01862107
First received: May 22, 2013
Last updated: April 11, 2014
Last verified: March 2014
  Purpose

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.

Condition
Neurological Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cerebrospinal Fluid Collection and Repository Storage

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Establishment of a repository [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: May 2013
Estimated Study Completion Date: April 2063
Estimated Primary Completion Date: April 2063 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862107

Contacts
Contact: Gloria von Geldern, M.D. (301) 451-4585 gloria.vongeldern@nih.gov
Contact: Avindra Nath, M.D. (301) 496-1561 natha@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01862107     History of Changes
Other Study ID Numbers: 130140, 13-N-0140
Study First Received: May 22, 2013
Last Updated: April 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Biomarkers
Immune Responses
Lumbar Puncture
Neurological Diseases
Novel Pathogens

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014