Cerebrospinal Fluid Collection and Repository Storage

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ClinicalTrials.gov Identifier: NCT01862107

Recruitment Status : Recruiting

First Posted : May 24, 2013

Last Update Posted : July 1, 2022

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Description

Brief Summary:

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 or disease
Nervous System Diseases

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	1500 participants
Observational Model:	Other
Time Perspective:	Other
Official Title:	Cerebrospinal Fluid Collection and Repository Storage
Actual Study Start Date :	July 29, 2013
Estimated Primary Completion Date :	May 9, 2029
Estimated Study Completion Date :	April 30, 2063

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neurologic Diseases

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

The primary objective of this study is to create a repository of CSF and matched serum and plasma samples. [ Time Frame: ongoing ]
Repository of CSF and matched blood.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

The study is a collection of CSF from any patient getting a lumbar puncture done for either clinical care or research purposes.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862107

Contacts

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Contact: Amanda M Wiebold	(301) 594-5194	amanda.wiebold@nih.gov
Contact: Avindra Nath, M.D.	(301) 496-1561	natha@mail.nih.gov

Locations

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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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Kuntz KM, Kokmen E, Stevens JC, Miller P, Offord KP, Ho MM. Post-lumbar puncture headaches: experience in 501 consecutive procedures. Neurology. 1992 Oct;42(10):1884-7.

Silverberg GD, Heit G, Huhn S, Jaffe RA, Chang SD, Bronte-Stewart H, Rubenstein E, Possin K, Saul TA. The cerebrospinal fluid production rate is reduced in dementia of the Alzheimer's type. Neurology. 2001 Nov 27;57(10):1763-6.

Ebinger F, Kosel C, Pietz J, Rating D. Headache and backache after lumbar puncture in children and adolescents: a prospective study. Pediatrics. 2004 Jun;113(6):1588-92.

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Responsible Party:	National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:	NCT01862107
Other Study ID Numbers:	130140 13-N-0140
First Posted:	May 24, 2013 Key Record Dates
Last Update Posted:	July 1, 2022
Last Verified:	September 8, 2021

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):


Biomarkers Immune Responses Lumbar Puncture	Neurological Diseases Novel Pathogens Natural History

Additional relevant MeSH terms:

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Nervous System Diseases

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