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
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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.
Condition or disease |
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Nervous System Diseases |
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 |

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

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, Learn About Clinical Studies.
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 |
- 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.

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
Contact: Amanda M Wiebold | (301) 594-5194 | amanda.wiebold@nih.gov | |
Contact: Avindra Nath, M.D. | (301) 496-1561 | natha@mail.nih.gov |
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 |
Principal Investigator: | Avindra Nath, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
Publications:
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 |
Biomarkers Immune Responses Lumbar Puncture |
Neurological Diseases Novel Pathogens Natural History |
Nervous System Diseases |