CoMind Early Feasibility Study

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT06368648

Run by

CoMind Technologies Limited

People needed

581

Starts

2024-11-27

Expected to finish

2026-11-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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