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Sound waves may replace spinal taps for brain pressure checks

NCT ID NCT06571786

Diagnosis Sponsor: Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a noninvasive ultrasound technique called SHAPE to measure pressure inside the skull. Nineteen adults scheduled for a lumbar puncture received an ultrasound contrast agent (Definity) while researchers compared the ultrasound readings to the standard needle-based pressure measurement. The goal was to see if the ultrasound method could accurately estimate intracranial pressure without a spinal tap.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Perflutren lipid microsphere (Definity)
What this could lead to
If successful, this could provide a needle-free way to measure pressure inside the skull, reducing the need for lumbar punctures.
What could go wrong
This is a small pilot study with only 19 participants, so results may not apply to everyone. The technique is still experimental and not ready for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pseudotumor cerebri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lumbar puncture

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.