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

Post-Lumbar Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06062446
• Other study ID #: HSC-MS-23-0732
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Jay-Jiguang Zhu, MD,PhD
• Phone: (713) 486-8000
• Email: Jay.Jiguang.Zhu[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Post-Lumbar Puncture Headache
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of participants that use the epidural blood patch		1 day after the LP
Secondary	Number of participants that use the epidural blood patch		3 days after the LP
Secondary	Number of participants that use the epidural blood patch		5 days after the LP