CoMind Early Feasibility Study
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
- Intracranial Pressure
- Intracranial Pressure Changes
- Traumatic Brain Injury
- Intracerebral Hemorrhage
- Encephalitis
- Encephalopathy
- Hydrocephalus
- Stroke
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- CoMind Technologies Limited
- Enrolment target
- 581
- Started
- 27 November 2024
- Main results due
- November 2026
- Study sites
- 17
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.
Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.
Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.
Study sites(17)
Banner University Medical Center
Phoenix, Arizona, United States
Recruiting
UC Davis Medical Center
Sacramento, California, United States
Recruiting
Christiana Care
Wilmington, Delaware, United States
Completed
Medstar Health
Washington D.C., District of Columbia, United States
Recruiting
Jackson Memorial Hospital
Miami, Florida, United States
Recruiting
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, United States
Active, not recruiting
Washington University Medical Center
St Louis, Missouri, United States
Recruiting
Albany Medical College
Albany, New York, United States
Active, not recruiting
Stony Brook University Hospital
Stony Brook, New York, United States
Recruiting
WakeMed
Raleigh, North Carolina, United States
Recruiting
Ohio State University
Columbus, Ohio, United States
Recruiting
Oregon Health & Science University
Portland, Oregon, United States
Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Active, not recruiting
University of Washington, Harborview
Seattle, Washington, United States
Recruiting
Showing 17 of 17 sites. 13 of the 17 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06368648. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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