Clinical trial NCT06062446: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post-Lumbar Puncture Headache
Keywords: lumbar puncture
headache
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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
* Participants with LP procedural complications that require a needle type or needle size change

Primary outcomes:
measure: Number of participants with headaches as assessed by a questionnaire
timeFrame: 30-60 minutes after LP
measure: Number of participants with headaches as assessed by a questionnaire
timeFrame: 1 day after LP
measure: Number of participants with headaches as assessed by a questionnaire
timeFrame: 3 days after LP
measure: Number of participants with headaches as assessed by a questionnaire
timeFrame: 5 days after LP
Secondary outcomes:
measure: Number of participants that use the epidural blood patch
timeFrame: 1 day after the LP
measure: Number of participants that use the epidural blood patch
timeFrame: 3 days after the LP
measure: Number of participants that use the epidural blood patch
timeFrame: 5 days after the LP
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jay-Jiguang Zhu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: