No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
581 (estimated)
Sponsor
CoMind Technologies Limited · Industry
Who this trial is looking for
This trial is looking for adults with serious brain issues who are already receiving invasive brain pressure monitoring. Participants will help test a new, non-surgical device designed to measure brain pressure safely.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older.
I am receiving continuous brain pressure monitoring.
I have a monitoring device inserted in my brain.
I am receiving continuous blood pressure monitoring.
You may not be able to join if
I have any implant in my forehead area that could touch the device.
I have open wounds on my forehead.
I have a broken skull in the area where the device would go.
I am part of another study that could affect measurements.
I have had a part of my skull removed unless the device can be placed on intact skull.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 s…
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 Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
4. Receiving continuous invasi…
Inclusion Criteria:
1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
4. Receiving continuous invasive ABP monitoring as part of standard care.
Exclusion Criteria:
1. 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.
2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
4. 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.
5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.
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