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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06062446
Other study ID # HSC-MS-23-0732
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2023
Est. completion date August 31, 2025

Study information

Verified date May 2024
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
Health authority
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 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

Study Design


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
See also
  Status Clinical Trial Phase
Withdrawn NCT00373074 - Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH) Phase 2/Phase 3
Recruiting NCT01481922 - What Needle Diameter Should Physician Use When They Perform Lumbar Puncture ? A Randomized Controlled Trial Phase 4
Completed NCT01977898 - Incidence of Headache Following an Unintentional Dural Puncture N/A
Completed NCT03960749 - Headache After Diagnostic Lumbar Puncture N/A