CoMind Early Feasibility Study

Last updated: February 12, 2026
Sponsor: CoMind Technologies Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Hemorrhage

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT06368648
CP-1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Presence of any implant (cosmetic or otherwise) in the frontal bone in suchproximity 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 placedover an area of intact skin

  3. Presenting with radiographic evidence of a non-intact skull at the recording site onadmission.

  4. If patient is enrolled in an intervention/study that may interfere with SoC ICPmeasurements or the CoMind One EFS device measurement then the patient isineligible.

  5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFSrecording can be made from intact skull.

Study Design

Total Participants: 581
Study Start date:
November 27, 2024
Estimated Completion Date:
November 30, 2026

Study Description

A prospective, observational study, determined as non-significant risk by the Central IRB, to assess and improve performance of a non-invasive ICP estimation system. The development of non-invasive systems is intended to replace the need for invasive ICP monitors. Participants serve as their own controls with concurrent, synchronous measurements of ICP (measured invasively as per standard clinical practice), Arterial Blood Pressure (ABP- measured invasively as per standard clinical practice), and measurements of a novel non- invasive cerebral blood-flow index (CBFi) from the CoMind One EFS device. These signals will be recorded simultaneously. The ABP and CBFi will serve as inputs to a model which outputs a non-invasive estimate of ICP, and the invasive ICP signal will be used to supervise and evaluate the performance of the non-invasive ICP estimation model. A large volume of data shall be collected for the purposes of training and testing the non-invasive ICP model. The Sponsor will report limits of agreement (LOA) between data-driven estimates of ICP and the invasively measured signal. In addition, this study will compare metrics built on non-invasive estimation of ICP or CBFi that indicate the state of CAR, and the limits of Autoregulation.

Connect with a study center

  • UC Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Christiana Care

    Wilmington 4145381, Delaware 4142224 19899
    United States

    Site Not Available

  • Medstar Health

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Jackson Memorial Hospital

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • The University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66103
    United States

    Site Not Available

  • Washington University Medical Center

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Albany Medical College

    Albany 5106834, New York 5128638 12208
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook 5139865, New York 5128638 11794
    United States

    Site Not Available

  • WakeMed

    Raleigh 4487042, North Carolina 4482348 27610
    United States

    Active - Recruiting

  • Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • University of Pennsylvania Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Inova Fairfax Medical Campus

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

  • University of Washington, Harborview

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Washington, Harborview

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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