CoMind Early Feasibility Study

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. 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.

Conditions

Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage, Encephalitis, Encephalopathy, Hydrocephalus, Stroke, Autoregulation

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Study Overview

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Study Details

Study overview

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.

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

CoMind Early Feasibility Study

Condition
Intracranial Pressure
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington, Harborview, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CoMind Technologies Limited,

Ramani Balu, MD, PhD, PRINCIPAL_INVESTIGATOR, Inova Fairfax Hospital

Study Record Dates

2025-10