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New treatment option for Post-Lumbar Puncture Headache
Official title A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients
ClinicalTrials.gov ID: NCT06062446
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.