Cerebrospinal Fluid Collection and Repository Storage

NCT ID: NCT01862107

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-29

Study Completion Date

2025-04-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nervous System Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Healthy Volunteer

Any healthy volunteer getting a lumbar puncture done for either clinical care or research purposes.

No interventions assigned to this group

Patient

Any patient getting a lumbar puncture done for either clinical care or research purposes.

No interventions assigned to this group

Eligibility Criteria

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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.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avindra Nath, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Neurological Disorders and Stroke (NINDS)

Locations

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National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 1407567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11723260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15173478 (View on PubMed)

Related Links

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Other Identifiers

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13-N-0140

Identifier Type: -

Identifier Source: secondary_id

130140

Identifier Type: -

Identifier Source: org_study_id

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