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RecruitingNAINTERVENTIONAL

Crainio Non-invasive ICP Monitor for TBI

This study is looking at a new device called Crainio which aims to measure pressure inside the brain, known as Intracranial Pressure (ICP), without the need for an operation. Currently, measuring ICP involves a small surgery, which carries some risks. Crainio uses special light to detect changes in brain tissue, offering a potentially much safer and simpler way to check brain pressure in people with head injuries. The main goal is to see if Crainio is accurate enough to safely flag when brain pressure is too high. Researchers will also look at how comfortable the device is for patients and how easy it is for medical staff to use.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Crainio Ltda
Enrolment target
54
Start
15 May 2025
Estimated completion
15 Dec 2026

What is this study about?

When someone has a serious head injury, it's really important for doctors to know if the pressure inside their head (called Intracranial Pressure or ICP) is getting too high. If the pressure becomes too great, it can stop enough blood and oxygen from reaching the brain, which can cause serious harm and is unfortunately a common cause of death in severe head injuries.

Currently, to measure this pressure, doctors need to perform a small operation. This involves placing a small tube or sensor directly into the skull. While this is an important procedure, it does come with some risks, like bleeding or infection. Also, it can only be done in hospitals that have special surgical teams, which means there can sometimes be delays in starting this monitoring.

This study is testing a new device called Crainio. It's designed to measure brain pressure using a completely non-surgical method. It works by shining a special light onto your forehead, which then helps detect changes in the blood vessels inside your brain without ever touching the brain directly. The researchers want to see if this new, simpler method can accurately detect high brain pressure, just as well as the current surgical methods. They also want to understand if different things, like the colour of a person’s skin or the thickness of their skull, affect how well the device works. They’ll also be asking patients and medical staff what they think of the device.

Key takeaways

  • The study is testing a new, non-surgical way to measure brain pressure.
  • This new device, called Crainio, sits on your forehead.
  • It aims to replace current methods that involve a small operation.
  • You would only be in the study if you are already having your brain pressure measured by the standard method.
  • The study aims to improve care for future patients with head injuries.

Who may be eligible?

This study is looking for adults aged between 16 and 99 who have been admitted to The Royal London Hospital because of a traumatic head injury. Crucially, you must already be having your brain pressure monitored using the standard surgical method as part of your normal treatment. This allows the researchers to compare the new device's readings with the established method.

There are also some reasons why you might not be able to join the study. For example, if the skin on your forehead isn't intact (perhaps due to an injury there), or if you've had a specific type of brain surgery called a decompressive craniectomy. Also, if you are undergoing a particular treatment called open external ventricular drainage, or if doctors believe you are unlikely to survive for the next 12 hours, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged between 16 and 99?
  2. Do you have a head injury and are being treated at The Royal London Hospital?
  3. Are your doctors already monitoring your brain pressure with the standard surgical method?
  4. Is the skin on your forehead intact (not broken or injured)?
  5. Have you not had a specific type of brain surgery called a decompressive craniectomy?
  6. Are you not receiving a specific treatment called open external ventricular drainage?
Answer every question to see your result.

What does participation involve?

As a participant in this study, the Crainio device would be placed gently on your forehead. This device would collect information about your brain without touching it directly. This would happen while you are already having your brain pressure monitored using the standard surgical method, as part of your regular medical care for your head injury. The study aims to collect this information over a period of up to 12 months, although the time you are involved might be shorter depending on your medical needs. There are no extra visits or medications required for this study beyond your standard medical care.

Potential risks and benefits

A potential benefit of taking part is contributing to research that could lead to a safer and less invasive way to monitor brain pressure for future patients with head injuries. Currently, there are no direct medical benefits to you as a participant, as your treatment will continue as normal. Regarding risks, the Crainio device is non-invasive, meaning it doesn't enter your body, so direct medical risks are expected to be very low. You might feel a slight pressure or warmth on your forehead where the device is placed. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal London Hospital
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is 'Intracranial Pressure' (ICP)?

ICP is the pressure inside your skull and around your brain. If it gets too high, it can be dangerous for your brain.

What is the new Crainio device?

It's a device that sits on your forehead and uses light to measure brain pressure without needing surgery.

Will this device change my medical treatment?

No, the Crainio device won't change your medical treatment. It's for research only, and your doctors will continue to use standard methods.

Is the Crainio device safe?

Because it's non-invasive and just sits on your forehead, it's expected to be very safe with minimal risks.

How long will I be in the study?

Your involvement in the study could last up to 12 months, but it will depend on your hospital stay and medical condition.

How to find out more

Jeremy Holland, Dr

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Crainio Non-invasive ICP Monitor for TBI…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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