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

NCT06062446 | Recruiting FDA Device

• 1 other identifier: HSC-MS-23-0732
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

lumbar puncture; headache

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (1)

Modified Lumbar Puncture

EXPERIMENTAL

Procedure: Modified Lumbar Puncture

Interventions

Modified Lumbar Puncture PROCEDURE

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).

Modified Lumbar Puncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay-Jiguang Zhu, MD,PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay-Jiguang Zhu, MD,PhD

CONTACT

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

Austin Lu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: November 8, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)