RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-11-08
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06062446

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who can sign informed consent
  2. * Participants who have stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Participants receiving a LP per standard of care (SOC) need for diagnostic or therapeutic purposes only
  4. * Participants with Karnofsky Performance Scale (KPS) ≥ 60
  1. * Participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches
  2. * Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt
  3. * Participants with more than one dural puncture during the same LP procedure
  4. * Participants have chronic coagulopathy with elevated prothrombin time (PT), Partial thromboplastin time (PTT), and International Normalized ration (INR).
  5. * Participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to LP per SOC guidance.
  6. * Participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both
  7. * Participants with severe spinal column deformities, such as scoliosis. Disc diseases are not exclusion criteria XX
  8. * Participants with LP procedural complications that require a needle type or needle size change

Contacts and Locations

Study Contact

Jay-Jiguang Zhu, MD,PhD
CONTACT
(713) 486-8000
Jay.Jiguang.Zhu@uth.tmc.edu
Joshua Nahm
CONTACT
(713) 486-8000
Joshua.K.Nahm@uth.tmc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-11-08
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • lumbar puncture
  • headache

Additional Relevant MeSH Terms

  • Post-Lumbar Puncture Headache