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CoMind Early Feasibility Study

Sponsored by CoMind Technologies Limited

About this study

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.

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…

Where this study is enrolling (12)

Show all 12 locations
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.