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Brain pressure monitor could eliminate need for drilling into skull

NCT ID NCT06368648

Knowledge-focused Sponsor: CoMind Technologies Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study is testing a new device that aims to measure pressure inside the skull from the outside, avoiding the need for surgery. Currently, doctors must drill a hole in the skull to monitor intracranial pressure (ICP) in patients with conditions like traumatic brain injury or stroke. The research will collect data from 581 patients who already have the standard surgical monitor in place, using the new device on their head to see if it can accurately estimate ICP. If the device works, it could provide a safer and less painful way to monitor brain pressure.

What this could mean

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

Active substance
CoMind One EFS device (non-invasive sensor)
What this could lead to
If successful, this could lead to a safer, non-surgical way to monitor brain pressure, reducing infection and pain risks for patients.
What could go wrong
This is an early feasibility study focused on data collection and model development. The device is not yet proven to be accurate or reliable for clinical 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.

Participants

About 581 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Any participant (18 years or older) who is undergoing invasive ICP monitoring and continuous ABP monitoring as part of their normal medical treatment at selected clinical sites. The majority of such participants will have sustained a Traumatic Brain Injury (TBI), but some may have Intracerebral Haemorrhage (ICH), Encephalitis, various metabolic Encephalopathies (notably hepatic), Hydrocephalus (both communicating and non-communicating), or Stroke, although this is not an exhaustive list of participant conditions.

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: 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.

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Conditions

The condition(s) this trial relates to.

brain disorder Brain Injuries, Traumatic encephalitis hydrocephalus intracerebral hemorrhage intracranial hypertension stroke disorder traumatic brain injury

As listed by the trial registrant

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

Autoregulation Encephalitis Encephalopathy Hydrocephalus Intracerebral hemorrhage Intracranial pressure Intracranial pressure changes Stroke Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical College

    ACTIVE_NOT_RECRUITING

    Albany, New York, 12208, United States

  • Christiana Care

    COMPLETED

    Wilmington, Delaware, 19899, United States

  • Inova Fairfax Medical Campus

    ACTIVE_NOT_RECRUITING

    Falls Church, Virginia, 22042, United States

  • Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • Medstar Health

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The University of Kansas Medical Center

    ACTIVE_NOT_RECRUITING

    Kansas City, Kansas, 66103, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Iowa Hospital and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Pennsylvania Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington, Harborview

    RECRUITING

    Seattle, Washington, 98104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • WakeMed

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Washington University Medical Center

    RECRUITING

    St Louis, Missouri, 63110, United States

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