A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
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
What is being tested
- Modified Lumbar Puncture (procedure)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 100 · Started: Nov 8, 2023
Contact the study team
- Jay-Jiguang Zhu, MD,PhD · Phone: (713) 486-8000
- Austin Lu · Phone: (713) 486-7758
Official record on ClinicalTrials.gov — NCT06062446
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.