Noninvasive ultrasound technique for assessing intracranial pressure
Subharmonic Aided Pressure Estimation (SHAPE) for Intracranial Pressure (ICP) Assessment
PHASE2 · Thomas Jefferson University · NCT06571786
This study is testing a new ultrasound method to see if it can safely measure brain pressure without needing invasive procedures for people undergoing lumbar punctures.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT06571786 on ClinicalTrials.gov |
What this trial studies
The SHAPE technique utilizes a noninvasive ultrasound-based imaging method to estimate ambient pressure by analyzing subharmonic emissions from ultrasound contrast agents. This approach involves the use of encapsulated microbubbles that respond to high acoustic pressures, allowing for the measurement of intracranial pressure (ICP) during lumbar puncture procedures. The study aims to evaluate the effectiveness of this technique in providing accurate pressure assessments without the need for invasive procedures. Participants will receive perflutren lipid microspheres as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for a lumbar puncture to assess ICP pressures.
Not a fit: Patients who are pregnant, nursing, medically unstable, or allergic to components of the contrast agent will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a safer and more accurate method for assessing intracranial pressure in patients.
How similar studies have performed: While this approach is innovative, similar studies using ultrasound techniques for pressure estimation have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for lumbar puncture to assess ICP pressures * Age over 18. Exclusion Criteria: * Pregnant or nursing * Medically unstable * Allergy to any components of Definity. * Unable to provide written informed consent
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (COMPLETED)
Study contacts
- Study coordinator: Flemming Forsberg, PhD
- Email: flemming.forsberg@jefferson.edu
- Phone: 2159554870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Puncture