Back to resultsA Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
Primary Purpose
Post-Lumbar Puncture Headache
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Lumbar Puncture
Sponsored by
About this trial
This is an interventional treatment trial for Post-Lumbar Puncture Headache focused on measuring lumbar puncture, headache
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified Lumbar Puncture
Arm Description
Outcomes
Primary Outcome Measures
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?
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?
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?
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?
Secondary Outcome Measures
Number of participants that use the epidural blood patch
Number of participants that use the epidural blood patch
Number of participants that use the epidural blood patch
Full Information
NCT ID
NCT06062446
First Posted
September 25, 2023
Last Updated
October 3, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT06062446
Brief Title
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
Official Title
A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lumbar Puncture Headache
Keywords
lumbar puncture, headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified Lumbar Puncture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Modified Lumbar Puncture
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants with headaches as assessed by a questionnaire
Description
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?
Time Frame
30-60 minutes after LP
Title
Number of participants with headaches as assessed by a questionnaire
Description
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?
Time Frame
1 day after LP
Title
Number of participants with headaches as assessed by a questionnaire
Description
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?
Time Frame
3 days after LP
Title
Number of participants with headaches as assessed by a questionnaire
Description
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?
Time Frame
5 days after LP
Secondary Outcome Measure Information:
Title
Number of participants that use the epidural blood patch
Time Frame
1 day after the LP
Title
Number of participants that use the epidural blood patch
Time Frame
3 days after the LP
Title
Number of participants that use the epidural blood patch
Time Frame
5 days after the LP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay-Jiguang Zhu, MD,PhD
Phone
(713) 486-8000
Email
Jay.Jiguang.Zhu@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Nahm
Phone
(713) 486-8000
Email
Joshua.K.Nahm@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay-Jiguang Zhu, MD,PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay-Jiguang Zhu, MD,PhD
Phone
713-486-8000
Email
Jay.Jiguang.Zhu@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Joshua Nahm
Phone
(713) 486-5080
Email
Joshua.K.Nahm@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
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