A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients

Description

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

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Study Overview

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Study Details

Study overview

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

A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients

A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients

Condition
Post-Lumbar Puncture Headache
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 XX
  • * Participants with LP procedural complications that require a needle type or needle size change

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Jay-Jiguang Zhu, MD,PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2025-08-31