Ultrasound Technique for Spinal Tap Assessment
Trial Summary
What is the purpose of this trial?
The Subharmonic Aided Pressure Estimation (SHAPE) technique is a noninvasive ultrasound-based imaging technique that can estimate ambient pressure using subharmonic emissions from ultrasound contrast agents. Ultrasound contrast agents are encapsulated microbubbles (mean diameter \< 8 µm) with a lipid, protein, or polymer shell that traverse the entire vasculature. When the contrast microbubbles are insonated with relatively high acoustic pressures (\>100-150 kPa), these microbubbles act as nonlinear oscillators yielding energy components in the received echo signals at frequencies ranging from the subharmonic (half of transmit frequency) to higher harmonics and even ultraharmonics. Based on empirical evidence, the subharmonic signal exhibits a sigmoidal relationship with incident acoustic pressure i.e., subharmonic signal can be divided into occurrence, growth and saturation stages. In the growth stage, the subharmonic signal has shown sensitivity to ambient pressure characterized by an inverse linear relationship between subharmonic signal and ambient pressure changes. This inverse linear relationship forms the basis for the SHAPE technique. Several pre-clinical and clinical studies have been conducted to utilize the SHAPE technique for in vivo pressure estimation e.g., to diagnose portal hypertension, to estimate intra-cardiac pressures and to determine interstitial fluid pressures. The core imaging mode underpinning the SHAPE technology (subharmonic imaging) is now available on some commercial scanners. In the proposed pilot study, the SHAPE technique will be leveraged for monitoring intracranial pressure (ICP). The use of SHAPE technique for the ophthalmic artery could potentially provide an accurate noninvasive method of measuring ICP in patients with idiopathic intracranial hypertension (IIH) and other conditions of raised ICP, which would revolutionize the field.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the ultrasound technique for spinal tap assessment safe for humans?
How does the treatment Perflutren lipid microsphere differ from other treatments for spinal tap assessment?
Perflutren lipid microsphere is unique because it uses ultrasound to activate tiny bubbles that can enhance imaging and potentially improve the precision of spinal tap procedures. This approach is different from traditional methods as it combines ultrasound with microbubbles to provide better visualization and assessment.26789
Eligibility Criteria
This trial is for adults over the age of 18 who are scheduled to undergo a lumbar puncture, commonly known as a spinal tap, to measure intracranial pressure (ICP).Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo noninvasive ultrasound-based imaging using the SHAPE technique to estimate intracranial pressure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Perflutren lipid microsphere
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Mayo Clinic
Collaborator