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NCT Number: NCT06062446

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

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Key information

Conditions

Post-Lumbar Puncture Headache Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Lumbar Puncture

Procedure

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 outcomes

  1. Number of participants with headaches as assessed by a questionnaire

    Time frame: 30-60 minutes after LP

    Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?

  2. Number of participants with headaches as assessed by a questionnaire

    Time frame: 1 day after LP

    Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?

  3. Number of participants with headaches as assessed by a questionnaire

    Time frame: 3 days after LP

    Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?

  4. Number of participants with headaches as assessed by a questionnaire

    Time frame: 5 days after LP

    Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?

Secondary outcomes

  1. Number of participants that use the epidural blood patch

    Time frame: 1 day after the LP

  2. Number of participants that use the epidural blood patch

    Time frame: 3 days after the LP

  3. Number of participants that use the epidural blood patch

    Time frame: 5 days after the LP

Study contacts

Contact information is provided by the study sponsor or research team.

Austin Lu

CONTACT

[email protected]

(713) 486-7758

Jay-Jiguang Zhu, MD,PhD

CONTACT

[email protected]

(713) 486-8000

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2023
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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