Status:
RECRUITING
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Post-Lumbar Puncture Headache
Eligibility:
All Genders
18+ years
Phase:
NA
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 epid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06062446
Start Date
November 8 2023
End Date
April 1 2026
Last Update
June 13 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030