A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients

A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients

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

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