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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Lumbar Puncture Headache
• Intervention / Treatment: Procedure: Modified Lumbar Puncture

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jay-Jiguang Zhu, MD,PhD; Phone Number: (713) 486-8000; Email: Jay.Jiguang.Zhu@uth.tmc.edu
• Study Contact Backup: Name: Joshua Nahm; Phone Number: (713) 486-8000; Email: Joshua.K.Nahm@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Jay-Jiguang Zhu, MD,PhD; Phone Number: 713-486-8000; Email: Jay.Jiguang.Zhu@uth.tmc.edu
      • Contact: Joshua Nahm; Phone Number: (713) 486-5080; Email: Joshua.K.Nahm@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Lumbar Puncture	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with headaches as assessed by a questionnaire	Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?	30-60 minutes after LP
Number of participants with headaches as assessed by a questionnaire	Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?	1 day after LP
Number of participants with headaches as assessed by a questionnaire	Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?	3 days after LP
Number of participants with headaches as assessed by a questionnaire	Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?	5 days after LP

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants that use the epidural blood patch	1 day after the LP
Number of participants that use the epidural blood patch	3 days after the LP
Number of participants that use the epidural blood patch	5 days after the LP

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jay-Jiguang Zhu, MD,PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: headache; lumbar puncture
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Wounds and Injuries; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: HSC-MS-23-0732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No