Cerebrospinal Fluid Collection and Repository Storage

NCT01862107 | Terminated

• 2 other identifiers: 13014013-N-0140
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Nervous System Diseases

Keywords

Biomarkers; Immune Responses; Lumbar Puncture; Neurological Diseases; Novel Pathogens; Natural History

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to create a repository of CSF and matched serum and plasma samples.

  Repository of CSF and matched blood.

  ongoing

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Subjects (patients and healthy volunteers) with the inability to provide informed consent either directly or via a legally authorized representative.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1212/wnl.42.10.1884.

  PMID: 1407567 BACKGROUND

• 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. doi: 10.1212/wnl.57.10.1763.

  PMID: 11723260 BACKGROUND

• 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. doi: 10.1542/peds.113.6.1588.

  PMID: 15173478 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Avindra Nath, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 24, 2013
• Study Start: July 29, 2013
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 24, 2025

Record last verified: 2024-06

Locations

US (1)