Brain pressure monitor could eliminate need for drilling into skull

NCT ID NCT06368648

Recruiting now Knowledge-focused Sponsor: CoMind Technologies Limited Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device that aims to measure pressure inside the skull from the outside, avoiding the need for surgery. Currently, doctors must drill a hole in the skull to monitor intracranial pressure (ICP) in patients with conditions like traumatic brain injury or stroke. The research will collect data from 581 patients who already have the standard surgical monitor in place, using the new device on their head to see if it can accurately estimate ICP. If the device works, it could provide a safer and less painful way to monitor brain pressure.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CoMind One EFS device (non-invasive sensor)
What this could lead to: If successful, this could lead to a safer, non-surgical way to monitor brain pressure, reducing infection and pain risks for patients.
What could go wrong: This is an early feasibility study focused on data collection and model development. The device is not yet proven to be accurate or reliable for clinical use.

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Conditions

The condition(s) this trial relates to.

brain disorder Brain Injuries, Traumatic encephalitis hydrocephalus intracerebral hemorrhage intracranial hypertension stroke disorder traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AUTOREGULATION ENCEPHALITIS ENCEPHALOPATHY HYDROCEPHALUS INTRACEREBRAL HEMORRHAGE INTRACRANIAL PRESSURE INTRACRANIAL PRESSURE CHANGES STROKE TRAUMATIC BRAIN INJURY

Contacts and locations

Locations

Albany Medical College
ACTIVE_NOT_RECRUITING

Albany, New York, 12208, United States
Christiana Care
ACTIVE_NOT_RECRUITING

Wilmington, Delaware, 19899, United States
Inova Fairfax Medical Campus
ACTIVE_NOT_RECRUITING

Falls Church, Virginia, 22042, United States
Jackson Memorial Hospital
RECRUITING

Miami, Florida, 33136, United States
Medstar Health
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20010, United States
Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Stony Brook University Hospital
NOT_YET_RECRUITING

Stony Brook, New York, 11794, United States
The University of Kansas Medical Center
ACTIVE_NOT_RECRUITING

Kansas City, Kansas, 66103, United States
UC Davis Medical Center
RECRUITING

Sacramento, California, 95817, United States
University of Pennsylvania Hospital
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Washington, Harborview
RECRUITING

Seattle, Washington, 98104, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
WakeMed
RECRUITING

Raleigh, North Carolina, 27610, United States
Washington University Medical Center
RECRUITING

St Louis, Missouri, 63110, United States

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