New headband could replace Needle-Based brain pressure monitoring

NCT ID NCT06453733

Recruiting now Diagnosis Sponsor: Crainio Ltda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called Crainio that uses infrared light to measure pressure inside the skull without needing to insert a probe into the brain. Researchers will enroll 54 adults with traumatic brain injury who already require standard invasive monitoring. The goal is to see if the device can accurately detect dangerously high brain pressure (above 20 mmHg) at least 90% of the time.

What this could mean

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

Active substance: Crainio device (non-invasive infrared sensor for intracranial pressure monitoring)
What this could lead to: If successful, this device could provide a safe, non-invasive way to monitor brain pressure in traumatic brain injury patients, reducing the need for invasive procedures.
What could go wrong: This is an early feasibility study with only 54 participants, so results may not apply broadly. The device is still being developed and may not achieve the desired accuracy.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for TRAUMATIC BRAIN INJURY are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

TRAUMATIC BRAIN INJURY

Contacts and locations

Locations

Royal London Hospital
RECRUITING

London, England, E1 1BB, United Kingdom

More trials for these conditions

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