Post-Lumbar Puncture HeadacheNCT06062446
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
A study testing Modified Lumbar Puncture in people with Post-Lumbar Puncture Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Lumbar Puncture Headache
- What is being tested?
- Modified Lumbar Puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who can sign informed consent
- Participants who have stated willingness to comply with all study procedures and availability for the duration of the study
- Participants receiving a LP per standard of care (SOC) need for diagnostic or therapeutic purposes only
- Participants with Karnofsky Performance Scale (KPS) ≥ 60
Who cannot join
- Participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches
- Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt
- Participants with more than one dural puncture during the same LP procedure
- Participants have chronic coagulopathy with elevated prothrombin time (PT), Partial thromboplastin time (PTT), and International Normalized ration (INR).
- Participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to LP per SOC guidance.
- Participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both
- Participants with severe spinal column deformities, such as scoliosis. Disc diseases are not exclusion criteria
- Participants with LP procedural complications that require a needle type or needle size change
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jay-Jiguang Zhu, MD,PhD, (713) 486-8000, Jay.Jiguang.Zhu@uth.tmc.edu
Austin Lu, (713) 486-7758, Austin.Lu@uth.tmc.edu
About this study
Official title: A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients
The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH
- Conditions
- Post-Lumbar Puncture Headache
- Being tested
- Modified Lumbar Puncture
- Keywords
- lumbar puncture, headache
- Medical subject headings
- Post-Dural Puncture Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Lumbar PunctureProcedure or surgery
The Investigator will perform the modified LP procedure using the 22 Gg needles Quincke spinal needle (namely, without reinsertion of stylet into the spinal needle after cerebrospinal fluid (CSF) collection before spinal needle removal).
| Study group | Role | What they receive |
|---|---|---|
| Modified Lumbar Puncture | Experimental | Not described Receives: Procedure: Modified Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with headaches as assessed by a questionnaire
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Measured: 30-60 minutes after LP
Number of participants with headaches as assessed by a questionnaire
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Measured: 1 day after LP
Number of participants with headaches as assessed by a questionnaire
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Measured: 3 days after LP
Number of participants with headaches as assessed by a questionnaire
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Measured: 5 days after LP
Secondary outcomes (3)
Number of participants that use the epidural blood patch
Measured: 1 day after the LP
Number of participants that use the epidural blood patch
Measured: 3 days after the LP
Number of participants that use the epidural blood patch
Measured: 5 days after the LP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start8 Nov 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Lumbar Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay-Jiguang Zhu, The University of Texas Health Science Center, Houston
- Investigators
- Jay-Jiguang Zhu, MD,PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062446
- Sponsor's protocol ID
- HSC-MS-23-0732
- Status last verified
- Jun 2025
- First submitted
- 25 Sep 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients
- ClinicalTrials.gov ID
- NCT06062446
- Acronym / sponsor ID
- HSC-MS-23-0732
- Conditions
- Post-Lumbar Puncture Headache
- Keywords
- lumbar puncture, headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Oct 2023 (actual)
- 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.
The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Lumbar Puncture | Experimental | Procedure: Modified Lumbar Puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who can sign informed consent
- Participants who have stated willingness to comply with all study procedures and availability for the duration of the study
- Participants receiving a LP per standard of care (SOC) need for diagnostic or therapeutic purposes only
- Participants with Karnofsky Performance Scale (KPS) ≥ 60
Key exclusion criteria (8 listed)
- Participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches
- Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt
- Participants with more than one dural puncture during the same LP procedure
- Participants have chronic coagulopathy with elevated prothrombin time (PT), Partial thromboplastin time (PTT), and International Normalized ration (INR).
- Participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to LP per SOC guidance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Lumbar PunctureThe Investigator will perform the modified LP procedure using the 22 Gg needles Quincke spinal needle (namely, without reinsertion of stylet into the spinal needle after cerebrospinal fluid (CSF) collection before spinal needle removal). | Procedure or surgery | Modified Lumbar Puncture |
Primary outcome
Number of participants with headaches as assessed by a questionnaire
Time frame: 30-60 minutes after LP
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Number of participants with headaches as assessed by a questionnaire
Time frame: 1 day after LP
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Number of participants with headaches as assessed by a questionnaire
Time frame: 3 days after LP
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
Number of participants with headaches as assessed by a questionnaire
Time frame: 5 days after LP
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
3 secondary outcomes
Number of participants that use the epidural blood patch
Time frame: 1 day after the LP
Number of participants that use the epidural blood patch
Time frame: 3 days after the LP
Number of participants that use the epidural blood patch
Time frame: 5 days after the LP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jay-Jiguang Zhu, MD,PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Lumbar Puncture in people with Post-Lumbar Puncture Headache, run by The University of Texas Health Science Center, Houston 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?
The sponsor lists 4 inclusion and 8 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 13 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay-Jiguang Zhu, MD,PhD ((713) 486-8000, Jay.Jiguang.Zhu@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with headaches as assessed by a questionnaire (time frame: 30-60 minutes after LP). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.