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Non-invasive measurement of brain pressure in patients with traumatic brain injury

An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device

Observational CoMind Technologies Limited · NCT06368648

This study is testing a new non-invasive device to measure brain pressure in patients with traumatic brain injury to see if it can replace the need for more risky surgical methods.

Quick facts

Study typeObservational
Enrollment581 (estimated)
Ages18 Years and up
SexAll
SponsorCoMind Technologies Limited Industry-sponsored
Locations14 sites (Sacramento, California and 13 other locations)
Trial IDNCT06368648 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data to develop a non-invasive device for measuring intracranial pressure (ICP) in patients with conditions like traumatic brain injury. Participants will have both a standard invasive ICP monitor and a novel non-invasive device applied simultaneously to collect data. The study will analyze the relationship between invasive ICP measurements and non-invasive estimates to improve the accuracy of the new device. The goal is to eliminate the need for surgical procedures currently required for ICP monitoring, thereby reducing associated risks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are receiving continuous invasive ICP monitoring as part of their standard care.

Not a fit: Patients with certain implants in the frontal bone or open wounds on the forehead may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more accessible monitoring of intracranial pressure for patients with brain injuries.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in developing non-invasive monitoring techniques, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
4. Receiving continuous invasive ABP monitoring as part of standard care.

Exclusion Criteria:

1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.
2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
4. If patient is enrolled in an intervention/study that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.
5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.

Where this trial is running

Sacramento, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracranial PressureIntracranial Pressure ChangesTraumatic Brain InjuryIntracerebral HemorrhageEncephalitisEncephalopathyHydrocephalusStroke
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.