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Recruiting NCT06062446

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

No phase Interventional Post-Lumbar Puncture Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Lumbar Puncture.
Who it may be relevant to
Registry conditions: Post-Lumbar Puncture Headache. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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).

Primary outcome measures

  • Number of participants with headaches as assessed by a questionnaire [Time frame: 30-60 minutes after LP]
  • Number of participants with headaches as assessed by a questionnaire [Time frame: 1 day after LP]
  • Number of participants with headaches as assessed by a questionnaire [Time frame: 3 days after LP]
  • Number of participants with headaches as assessed by a questionnaire [Time frame: 5 days after LP]
Secondary outcome measures (3)
  • Number of participants that use the epidural blood patch [Time frame: 1 day after the LP]
  • Number of participants that use the epidural blood patch [Time frame: 3 days after the LP]
  • Number of participants that use the epidural blood patch [Time frame: 5 days after the LP]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06062446 · HSC-MS-23-0732

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗