Developing a non-surgical device to estimate brain pressure
Studies a headset device that estimates brain pressure without surgery, in adults with brain conditions.
Plain-language title generated from the registry record
Registry title: CoMind Early Feasibility Study
Key facts
- Where
- Albany, Columbus, Falls Church, Iowa City, Kansas City, Miami, Nashville, Philadelphia, Phoenix, Portland, Raleigh, Sacramento, Seattle, St Louis, Stony Brook, Washington D.C., and Wilmington, United StatesSee the 17 sites
Where in United States
- Albany Medical CollegeAlbany, United StatesNo longer taking part
- Ohio State UniversityColumbus, United StatesTaking people
- Inova Fairfax Medical CampusFalls Church, United StatesNo longer taking part
- University of Iowa Hospital and ClinicsIowa City, United StatesTaking people
- The University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Jackson Memorial HospitalMiami, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- University of Pennsylvania HospitalPhiladelphia, United StatesTaking people
- Banner University Medical CenterPhoenix, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- WakemedRaleigh, United StatesTaking people
- UC Davis Medical CenterSacramento, United StatesTaking people
- University of Washington HarborviewSeattle, United StatesTaking people
- Washington University Medical CenterSt Louis, United StatesTaking people
- Stony Brook University HospitalStony Brook, United StatesTaking people
- MedStar HealthWashington D.C., United StatesTaking people
- Christiana CareWilmington, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CoMind Technologies Limited
- Trial code
- NCT06368648
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Male or female sex at birth, and aged 18 years or older on the date of enrollment; Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care; Invasive ICP monitor catheter penetrating the parenchyma or ventricles; Receiving continuous invasive ABP monitoring as part of standard care.
Exclusion: 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; Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin; Presenting with radiographic evidence of a non-intact skull at the recording site on admission; 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; Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.