CoMind Early Feasibility Study
CoMind EFS
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
1 other identifier
observational
581
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedStudy Start
First participant enrolled
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 13, 2026
October 1, 2025
1.9 years
April 11, 2024
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP.
The threshold limit of agreement will be evaluated at three levels corresponding to a model with clinical utility that is optimal, high, or moderate clinical utility. These levels of clinical utility are defined as follows: ● Optimal clinical utility: a model trained using CoMind CBFi and ABP can achieve LOA with invasive ICP less-than or equal to +/-2 mmHg in the range of ICP between 10-30 mmHg, and less-than or equal to +/-4 mmHg in the ranges of 0-10 mmHg, and 30-50 mmHg. ● High clinical utility: a model trained using CoMind CBFi and ABP can achieve LOA with invasive ICP less-than or equal to +/-3 mmHg in the range of ICP between 10-30 mmHg, and less-than or equal to +/-5 mmHg in the ranges of 0-10 mmHg, and 30-50 mmHg. ● Moderate clinical utility: a model that achieves LOA with invasive ICP less-than or equal to +/-4 mmHg in the range of ICP between 10-30 mmHg, and less-than or equal to +/-6 mmHg in the ranges of 0-10 mmHg, and 30-50 mmHg.
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Secondary Outcomes (4)
Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population.
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg).
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform.
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Demonstration of an non-invasive ICP model that can predict trends in ICP
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Other Outcomes (1)
A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP.
From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Study Arms (1)
Patients receiving invasive ICP and ABP monitoring as their standard of care
Patients who are receiving invasive Intracranial Pressure (ICP) monitoring and invasive Arterial Blood Pressure (ABP) monitoring as per standard practice will serve as their own controls.
Eligibility Criteria
Any participant (18 years or older) who is undergoing invasive ICP monitoring and continuous ABP monitoring as part of their normal medical treatment at selected clinical sites. The majority of such participants will have sustained a Traumatic Brain Injury (TBI), but some may have Intracerebral Haemorrhage (ICH), Encephalitis, various metabolic Encephalopathies (notably hepatic), Hydrocephalus (both communicating and non-communicating), or Stroke, although this is not an exhaustive list of participant conditions.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CoMind Technologies Limitedlead
- Lindus Healthcollaborator
Study Sites (14)
UC Davis Medical Center
Sacramento, California, 95817, United States
Christiana Care
Wilmington, Delaware, 19899, United States
Medstar Health
Washington D.C., District of Columbia, 20010, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66103, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Albany Medical College
Albany, New York, 12208, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
University of Washington, Harborview
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramani Balu, MD, PhD
Inova Fairfax Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2024
First Posted
April 16, 2024
Study Start
November 27, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 13, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share