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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (14)

UC Davis Medical Center
Sacramento, California, United States
Christiana Care
Wilmington, Delaware, United States
Medstar Health
Washington D.C., District of Columbia, United States
Jackson Memorial Hospital
Miami, Florida, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Washington University Medical Center
St Louis, Missouri, United States
Albany Medical College
Albany, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
WakeMed
Raleigh, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
University of Washington, Harborview
Seattle, Washington, United States