RecruitingNAINTERVENTIONAL

Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

This study, called EMBRI, is testing a new method to keep an eye on the brain during surgery. When surgeons operate on the brain, they sometimes need to use a tool to gently hold parts of the brain out of the way. This study wants to see if a special brain monitor, called an ECoG array, can detect early signs of stress or injury to the brain caused by this gentle repositioning. It's a first-time human study, building on earlier lab research, and involves adults who are already having brain surgery. The goal is to make these surgeries even safer in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

01 Aug 2022

Estimated completion

01 Mar 2026

Brain Injury Neurosurgery Brain Ischemia

What is this study about?

When you have brain surgery, doctors sometimes need to gently hold parts of your brain to get to the area they need to treat. This is a standard part of many operations. This study, called EMBRI (Electrocorticographic Monitoring of Brain Retraction Injury), is looking at a new way to make sure this process is as safe as possible.

The study involves placing a special, very thin sheet of recording sensors, called an ECoG array, on the surface of your brain during your planned surgery. This is done underneath where the surgeon might gently hold brain tissue aside. These sensors will record the electrical activity of your brain in that specific area. The idea is that these recordings might show very early signs if the brain tissue is becoming stressed or affected by being gently held, even before any problems would be noticeable in other ways.

This is a "first-in-human" study, which means it's the first time this specific monitoring technique is being used in people, based on promising research done in labs. The main goal is to see if this new monitoring method is practical and safe to use during surgery, and if it can successfully detect changes in brain activity that could signal a problem. Ultimately, the hope is that this technology could help doctors make brain surgery even safer and prevent complications.

Key takeaways

Tests a new temporary brain monitor during planned surgery.
Aims to detect subtle brain changes when tissue is gently moved.
Is a 'first in human' study to see if the method works and is safe.
No extra appointments or changes to your recovery are needed.
Your medical care is unaffected whether you join or not.

Who may be eligible?

This study is looking for adult patients who are already scheduled to have brain surgery. You need to be 16 years old or older to take part.

The surgery you are having must be one where your surgeon expects to use a special tool to gently hold brain tissue out of the way. This is a common part of many brain operations.

However, you cannot take part if, at the time the doctors talk to you about the study, you are unable to understand the information and give your permission (consent) to join.

Quick self-check

Are you 16 years old or older?
Are you already scheduled for brain surgery?
Does your surgeon expect to use a tool to gently move brain tissue during the operation?
Can you understand the study information and decide for yourself if you want to join?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your involvement would happen during your already planned brain surgery. There would be no extra hospital visits or changes to your recovery process related to the study.

During your surgery, after the surgeon has opened the area, they would place a small, thin sheet with sensors, called an ECoG array, directly onto the surface of your brain in a specific area. This is a temporary step. The sensors would then record your brain's electrical activity. This monitoring happens only during the surgery. Once the surgeon has finished the main part of the operation, the ECoG array would be removed before the surgeon closes the area. You would not notice the array and it would not stay in your head after the surgery.

Beyond what is already planned for your surgery and recovery, there are no additional medications, assessments, or follow-up appointments required specifically for this study. The total duration of your participation is essentially limited to the time you are in surgery.

Potential risks and benefits

Potential benefits of taking part in this study are mainly for future patients, as this research could help develop safer brain surgery techniques. For you personally, there is no direct medical benefit expected from the monitoring itself, as it's an exploratory study to gather information. The potential risks are considered low; the ECoG array is placed and removed during your existing surgery, adding only a very small amount of extra time to the procedure. There's a minimal theoretical risk of infection or bleeding, as with any device placed inside the body, but this is carefully managed by the surgical team. Remember, you can choose to join or leave the study at any time without affecting your medical care.

Locations (1)

National Hospital Neurology and Neurosurgery
London, United Kingdom· Recruiting

Common questions

What exactly will be done differently if I join the study?

During your planned brain surgery, a small, temporary monitoring device will be placed on your brain's surface to record its electrical activity, then removed before the surgery finishes. No other changes to your treatment.

Will this monitoring hurt or cause any new symptoms?

No, you will be under general anaesthetic during the surgery, so you won't feel anything. The device is temporary and should not cause any new symptoms.

How long will the monitoring device be in my head?

The device will only be in place during the surgery itself, for a few hours. It will be removed before the end of the operation.

Is this a new type of brain surgery?

No, you will be having your planned standard brain surgery. This study just adds a temporary monitoring step to that existing surgery.

What is 'brain retraction'?

Brain retraction is when surgeons gently and carefully move parts of the brain tissue slightly to the side to get a clear view of the area they need to operate on.

How to find out more

Siddharth Sinha

siddharth.sinha@ucl.ac.uk 004420 3456 7890 Official trial record

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