Actively Recruiting
Early Feasibility Study to Develop a Non-Invasive Model for Estimating Intracranial Pressure and Cerebral Autoregulation Using the CoMind One EFS Device
Led by CoMind Technologies Limited · Updated on 2026-02-13
581
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
Sponsors
C
CoMind Technologies Limited
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new non-invasive method to estimate intracranial pressure (ICP) and assess cerebral autoregulation (CAR) using the CoMind One EFS device. This observational study aims to develop safer alternatives to the current invasive ICP monitoring, which requires surgery to drill into the skull and carries risks like infection and pain. The study collects extensive data to improve the accuracy of this new technology for patients with conditions such as traumatic brain injury and stroke. Participants who are already receiving invasive ICP and arterial blood pressure (ABP) monitoring as part of their standard care will have concurrent measurements taken using the CoMind One EFS device. This device records a cerebral blood-flow index non-invasively, and these signals will be analyzed to create and test models estimating ICP without surgery. The study does not involve additional treatments but compares the new device's readings with existing invasive monitors during the observation period. During the study, participants will have simultaneous invasive and non-invasive ICP and ABP measurements recorded until either three weeks after removal of the CoMind device or discharge from the intensive care unit, whichever comes first. Researchers will analyze the data to evaluate the accuracy of the non-invasive device across different skin tones and its ability to detect changes in ICP states and trends. The goal is to gather detailed information to help develop a reliable, non-invasive ICP monitoring system.
CONDITIONS
Brief Title
CoMind Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female sex at birth, aged 18 years or older at enrollment
- Receiving continuous invasive intracranial pressure (ICP) monitoring (Bolt or EVD) as part of standard care
- ICP monitor catheter penetrating the brain tissue or ventricles
- Receiving continuous invasive arterial blood pressure (ABP) monitoring as part of standard care
You will not qualify if you...
- Any implant in the frontal bone near the sensor placement site
- Open wounds on the forehead preventing safe sensor placement
- Evidence of a non-intact skull at the recording site upon admission
- Enrollment in another study or intervention that may interfere with standard ICP measurements or the CoMind device
- Decompressive craniectomy patients unless recording can be made from intact skull
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to up to 3 weeks after removal of the CoMind device or until ICU discharge, whichever occurs sooner
Participants who undergo routine invasive intracranial pressure and arterial blood pressure monitoring as part of standard care are observed with additional non-invasive measurements using the CoMind One EFS device to collect data for developing and testing the ICP estimation model.
Continuous monitoring during ICU stay with device recording
Trial Site Locations
Total: 14 locations
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
Christiana Care
Wilmington, Delaware, United States, 19899
Active, Not Recruiting
3
Medstar Health
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
4
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Actively Recruiting
5
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Active, Not Recruiting
6
Washington University Medical Center
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Albany Medical College
Albany, New York, United States, 12208
Active, Not Recruiting
8
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Not Yet Recruiting
9
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
10
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
11
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Active, Not Recruiting
14
University of Washington, Harborview
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
D
David Diedo
B
Blake Butler
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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