Nervous System DiseasesNCT01862107
Cerebrospinal Fluid Collection and Repository Storage
An observational study of Nervous System Diseases, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2013to 23 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Nervous System Diseases
- Keywords
- Biomarkers, Immune Responses, Lumbar Puncture, Neurological Diseases, Novel Pathogens, Natural History
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start29 Jul 2013
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Why it stopped: Study terminated due to limited resources and declining participation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Avindra Nath, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862107
- Sponsor's protocol ID
- 130140
- Other IDs
- 13-N-0140
- Status last verified
- Jun 2024
- First submitted
- 22 May 2013
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. doi: 10.1212/wnl.42.10.1884.
PubMed 1407567Silverberg 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.
PubMed 11723260Ebinger 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.
PubMed 15173478
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Collection and Repository Storage
- ClinicalTrials.gov ID
- NCT01862107
- Acronym / sponsor ID
- 130140
- Conditions
- Nervous System Diseases
- Keywords
- Biomarkers, Immune Responses, Lumbar Puncture, Neurological Diseases, Novel Pathogens, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to limited resources and declining participation.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 29 Jul 2013 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Study terminated due to limited resources and declining participation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 1407567Kuntz 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.
- Background: PubMed 11723260Silverberg 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.
- Background: PubMed 15173478Ebinger 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avindra Nath, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nervous System Diseases, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to limited resources and declining participation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to create a repository of CSF and matched serum and plasma samples. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862107, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.