Developing a non-surgical device to estimate brain pressure

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who already have an invasive monitor in the brain to measure pressure and blood pressure as part of routine care. It tests a device that estimates brain pressure from outside.

Age

18 years or older

Sex

All sexes (male or female sex at birth)

Disease stage

People getting continuous invasive ICP monitoring (Bolt or EVD) as part of standard care. The conditions listed include traumatic brain injury, intracerebral hemorrhage, encephalitis, encephalopathy, hydrocephalus and stroke.

Earlier treatment

Must be getting continuous invasive ICP monitoring and continuous invasive ABP monitoring as part of standard care. Cannot be in another study that may interfere with the ICP measurements or the CoMind One EFS device.

Main reasons for not taking part

• An implant in the frontal bone so close to the CoMind One EFS Sensor that they might touch
• Open wounds on the forehead, so the sensor cannot sit on intact skin
• Signs on scanning of a non-intact skull at the recording site on admission
• Being in a study that may interfere with the ICP measurements or the CoMind One EFS device
• Decompressive craniectomy, unless a recording can be made from intact skull

The registry criteria, word for word

What the trial wants 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 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.

The group in the trial

• 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.