Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06062446

Conditions

Post-Lumbar Puncture Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Modified Lumbar Puncture

Study Details

Brief 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 reduce incidence of PLPH

Conditions

Post-Lumbar Puncture Headache

Study ID

NCT06062446

Start date

Nov 8, 2023

Status verified date

Jun, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Modified Lumbar Puncture

Interventions

Modified Lumbar Puncture

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).

Primary outcome measure

  • Number of participants with headaches as assessed by a questionnaire [ Time Frame: 30-60 minutes after LP ]
  • Number of participants with headaches as assessed by a questionnaire [ Time Frame: 1 day after LP ]
  • Number of participants with headaches as assessed by a questionnaire [ Time Frame: 3 days after LP ]
  • Number of participants with headaches as assessed by a questionnaire [ Time Frame: 5 days after LP ]

Central Contacts and Locations

Central contacts

Jay-Jiguang Zhu, MD,PhD

(713) 486-8000Jay.Jiguang.Zhu@uth.tmc.edu

Austin Lu

(713) 486-7758Austin.Lu@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jay-Jiguang Zhu, MD,PhD

(713) 486-8000Jay.Jiguang.Zhu@uth.tmc.edu

Austin Lu

(713) 486-7758Austin.Lu@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Keywords

  • lumbar puncture
  • headache

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-06-13.