Non-Invasive Device for Traumatic Brain Injury
(CoMind EFS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a safer method to measure pressure around the brain (intracranial pressure or ICP) without surgery. Currently, doctors must make a hole in the skull to measure this pressure, which can lead to infections and pain. The new device under testing could measure ICP externally, reducing risk. The trial includes individuals already undergoing surgery to monitor their ICP as part of their regular care. As a Phase 1 trial, this research focuses on understanding how the new device functions in people, offering participants the chance to be among the first to benefit from this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring brain pressure using a new device, so it's best to ask the study team for guidance.
What prior data suggests that this device is safe for measuring intracranial pressure?
Research has shown that new, non-invasive devices are being developed to measure brain pressure, aiming to reduce the risks of current methods. Traditional methods require surgery, which can lead to infections and pain. The new device uses gentle light to check brain pressure without surgery.
Studies have found this new method safe for people. Placed on the skin, the device does not cause infection or bleeding, common risks with surgery. Although still in development, early results suggest it could be a safer option for patients with traumatic brain injury (TBI) and other conditions requiring brain pressure monitoring.12345Why are researchers excited about this trial?
Researchers are excited about the CoMind treatment because it offers a unique approach to managing neurological conditions by leveraging brain-computer interface technology. Unlike traditional medications that target symptoms through chemical interactions, CoMind directly connects to the brain to modulate neural activity in real-time. This innovative mechanism could provide more precise control over symptoms and potentially deliver faster and more sustainable results. Additionally, by bypassing traditional drug pathways, CoMind might reduce side effects often associated with neurological medications.
What evidence suggests that this device is effective for monitoring intracranial pressure in traumatic brain injury?
Research has shown that pressure inside the skull can be measured without surgery in patients with head injuries. One study found these non-invasive methods accurate and potentially safer than current surgical techniques. Another study demonstrated that a computer model could continuously predict this pressure without surgery. These findings suggest that non-invasive tools, such as the device under study in this trial, might offer a safe and reliable way to monitor brain pressure.25678
Who Is on the Research Team?
Ramani Balu, MD, PhD
Principal Investigator
Inova Fairfax Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants undergo concurrent, synchronous measurements of ICP, ABP, and CBFi using both invasive and non-invasive methods
Follow-up
Participants are monitored for safety and effectiveness after the observation period
What Are the Treatments Tested in This Trial?
Interventions
- Non-invasive Intracranial Pressure Monitoring Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
CoMind Technologies Limited
Lead Sponsor
Lindus Health
Industry Sponsor
Citations
The use of noninvasive measurements of intracranial ...
In this study, we aimed to analyze the accuracy of noninvasive measurement methods for intracranial hypertension (IH) in patients with traumatic brain injury ( ...
Non-invasive intracranial pressure assessment in adult ...
Guochang Ye et al.'s recent study demonstrated the effectiveness of a machine learning-based model for continuous prediction of intracranial pressure in ...
Intracranial Pressure Monitoring and 6-Month Outcomes of ...
Patients who underwent ICP monitoring had a worse Glasgow Outcome Scale–Extended score at 6 months than the matched, nonmonitored control patients.
Non-invasive Intracranial Pressure Monitoring to Improve ...
The study aims to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) monitoring, ...
Intracranial Pressure Monitoring in Patients With Traumatic ...
There was no conclusive evidence that ICP monitoring reduces mortality in traumatic brain injury patients.
A Non-invasive Intracranial Pressure (nICP) Monitoring ...
The proposed non-invasive ICP (nICP) monitor works by shining a harmless light into the brain through the skull. The developed sensor was attached to the skin ...
Intracranial pressure monitoring: Gold standard and recent ...
An ideal monitor to track ICP should be easy to use, accurate, reliable, reproducible, inexpensive and should not be associated with infection or haemorrhagic ...
Predicting intracranial pressure monitor placement in children ...
Intracranial pressure monitoring in children with severe traumatic brain injury: National Trauma Data Bank-based review of outcomes . JAMA ...
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