CoMind Early Feasibility Study for Non-Invasive ICP Monitoring
This observational study is looking for information to help develop a new medical device called CoMind One EFS. This device aims to measure the pressure around the brain (intracranial pressure or ICP) without needing surgery. Currently, measuring ICP requires a surgical procedure, which carries risks like infection. This study will collect data from people who are already having their ICP and blood pressure (ABP) monitored invasively as part of their standard care. The CoMind One EFS device will also take measurements of cerebral blood flow (CBFi) at the same time. Researchers will use this information to train and evaluate new models that can estimate ICP non-invasively. The goal is to see how well these new models compare to the current invasive ICP measurements. You may be able to join if you are 18 or older and are already receiving continuous invasive ICP and ABP monitoring.
- Study design
- This is an observational study aiming to enroll 581 participants. It is designed to assess and improve the performance of a non-invasive ICP estimation system.
- What's involved
- You would have simultaneous measurements taken from your existing invasive ICP and ABP monitors, along with measurements from the CoMind One EFS device. These measurements will be recorded from enrollment until either 3 weeks after the CoMind device is removed or until you are discharged from the ICU, whichever comes first.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken from enrollment until either 3 weeks after the CoMind device is removed or until ICU discharge, whichever event is sooner.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CoMind Early Feasibility Study
At a glance
Conditions
Where it's being run
15 sites across 14 statesStudy leadership
- Ramani Balu, MD, PhD · PRINCIPAL_INVESTIGATOR · Inova Fairfax Hospital
Who to contact
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What this trial measures
- 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 ABPFrom 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.From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
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.