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Procedure

Modified Lumbar Puncture for Spinal Tap Headache

N/A
Recruiting
Led By Jay-Jiguang Zhu, MD,PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with Karnofsky Performance Scale (KPS) ≥ 60
Be older than 18 years old
Must not have
Participants with LP procedural complications that require a needle type or needle size change
Participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days after lp
Awards & highlights
No Placebo-Only Group

Summary

This trial studies if a modified procedure reduces the risk of PLPH and epidural blood patch (EBP) usage. Factors affecting risk are also identified.

Who is the study for?
This trial is for individuals who need a lumbar puncture (LP) for diagnostic or therapeutic reasons, can consent to the study, will follow all procedures, and have a Karnofsky Performance Scale score of 60 or above. It excludes those on certain blood thinners unless stopped as per guidelines, with chronic or acute headaches, recent neurosurgical implants, multiple dural punctures in one LP session, coagulopathy issues, procedural complications requiring needle changes, suspected high brain pressure or severe spinal deformities.
What is being tested?
The study tests whether a modified LP procedure can lower the occurrence of post-lumbar puncture headaches to 5% or less and reduce the need for epidural blood patch treatments to below 10% among those affected. It also aims to identify factors influencing these headaches' incidence.
What are the potential side effects?
While not explicitly stated in this summary information provided about side effects from the modified LP procedure itself; typically an LP may cause potential side effects such as back pain at the needle insertion site, minor bleeding into the skin around it and sometimes temporary numbness in your legs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I needed a different needle for my lumbar puncture due to complications.
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I might have increased pressure in my brain, as suggested by symptoms or scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days after lp
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days after lp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with headaches as assessed by a questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Modified Lumbar PunctureExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,757 Total Patients Enrolled
1 Trials studying Post-Lumbar Puncture Headache
Jay-Jiguang Zhu, MD,PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~38 spots leftby Aug 2025
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