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

NCT ID: NCT06062446

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2026-04-01

Brief Summary

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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

Detailed Description

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Conditions

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Post-Lumbar Puncture Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified Lumbar Puncture

Group Type EXPERIMENTAL

Modified Lumbar Puncture

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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 LP procedural complications that require a needle type or needle size change
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jay-Jiguang Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jay-Jiguang Zhu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jay-Jiguang Zhu, MD,PhD

Role: CONTACT

(713) 486-8000

Austin Lu

Role: CONTACT

(713) 486-7758

Facility Contacts

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Jay-Jiguang Zhu, MD,PhD

Role: primary

(713) 486-8000

Austin Lu

Role: backup

(713) 486-7758

Other Identifiers

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HSC-MS-23-0732

Identifier Type: -

Identifier Source: org_study_id

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