Modified lumbar puncture procedure to reduce headaches
Official title: A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients
Run by The University of Texas Health Science Center, Houston · NCT06062446 · Data updated 2026-11-12
This study is testing a new way to do lumbar punctures to see if it can lower the chances of headaches afterwards for people who need this procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | November 8, 2023 |
| Main results expected | April 1, 2026 |
| Study ends | April 1, 2026 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT06062446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals who require a lumbar puncture and have a Karnofsky Performance Scale score of 60 or higher.
✕Probably not a fit
Patients with a history of chronic headaches, recent neurosurgical device implants, or those on anticoagulant therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate a modified lumbar puncture (LP) procedure designed to decrease the incidence of post-lumbar puncture headaches (PLPH) to 5% or lower. It will also assess whether this modified procedure can reduce the need for epidural blood patches to 10% or lower among patients experiencing PLPH. The study will involve participants who require a lumbar puncture for diagnostic or therapeutic reasons and will monitor various factors that may influence the occurrence of PLPH.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of post-lumbar puncture headaches, improving patient comfort and outcomes.
How similar studies have gone: While there may be existing studies on lumbar puncture techniques, this specific modified approach is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Jay-Jiguang Zhu, MD,PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Jay-Jiguang Zhu, MD,PhD
- Email: Jay.Jiguang.Zhu@uth.tmc.edu
- Phone: (713) 486-8000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.