RecruitingNAINTERVENTIONAL

FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

This study is looking at brand new, super-thin sensors made from a special material called graphene. These sensors are designed to be used during brain tumour surgery. Doctors want to find out if these graphene sensors are safe and work effectively. They're hoping these new sensors can give clearer pictures of brain activity than current sensors, helping surgeons protect vital areas involved in speech and movement. You'd have your usual brain tumour surgery, with these new sensors being tested alongside standard equipment. There would be a follow-up MRI scan six weeks later to check for any issues.

At a glance

Status

Recruiting

Phase

Sponsor

University of Manchester

Enrolment target

Start

06 Aug 2024

Estimated completion

24 Jun 2026

Brain Tumor Glioma

What is this study about?

This study is testing a new type of device designed to help surgeons during brain tumour operations. Normally, doctors use special sensors (called electrodes) to check how the brain is working. These sensors help them see where important jobs like speaking or moving your arm are controlled, so they can avoid damaging those areas during surgery.

The current sensors have some limitations, for example, they can't always bend to fit the brain's curves perfectly. This new device, called the INBRAIN Graphene Cortical Interface, uses a very special and thin material called graphene. Because it's so thin and flexible, it should be able to fit the brain's surface much better, even in tricky areas. Also, graphene is much more sensitive, meaning these new sensors can pick up tiny electrical signals from the brain more clearly and in greater detail. This could give surgeons much more helpful information during the operation.

The main goal of this study is to make sure these new graphene sensors are safe to use during brain surgery. They also want to see how well they record brain signals and if they can gently stimulate the brain. If you take part, you'll still have your brain tumour surgery as planned. The new sensors will be used alongside the standard monitoring equipment. After the surgery, doctors will keep an eye on you for any problems and you'll have an extra MRI scan about six weeks later.

Key takeaways

New, super-thin sensors made from graphene are being tested during brain tumour surgery.
The main goal is to check if these new sensors are safe to use.
They aim to capture more detailed brain activity to help protect important functions.
Your brain tumour surgery will proceed as planned, with these sensors used alongside standard tools.
An extra MRI scan will be done 6 weeks after your surgery for monitoring.

Who may be eligible?

To be considered for this study, you would generally need to have a brain tumour that your doctor plans to remove with surgery. This surgery might be done while you're awake for part of it, or under a general anaesthetic where sensors are used to monitor your brain directly.

There are also some other important things that would make you suitable. For example, if your tumour is near areas that control speech, English would need to be your first language so you can do speech tasks. You would also need to be generally well and able to understand and agree to take part in the study.

However, you couldn't join the study if you've had brain surgery or radiotherapy before, or if you have certain medical conditions like problems with MRI scans (for example, if you have certain metal implants). If you are pregnant or breastfeeding, or have kidney problems, you also wouldn't be able to participate. Your doctor will be able to check all these details with you.

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.

Do you have a brain tumour that needs surgery?
Are you generally well and happy to give your permission to join?
Have you had brain surgery or radiotherapy before? (If yes, you might not be eligible)
Do you have any metal implants or conditions that prevent you from having an MRI scan? (If yes, you might not be eligible)
Are you pregnant or breastfeeding, or have kidney problems? (If yes, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you join this study, you’ll have your brain tumour surgery as planned. During the operation, the new graphene sensors will be used alongside the usual monitoring equipment. If you are awake for any part of your surgery, you might be asked to do simple tasks, like naming objects, to help doctors understand the brain signals. After your surgery, you'll be monitored for any problems. You will also have an extra MRI scan about six weeks after your operation to check how things are going. The total duration of your participation, including follow-up, will involve this six-week period after surgery.

Potential risks and benefits

The potential benefit of taking part is that these new sensors could provide better information during brain surgery, potentially helping surgeons protect important brain functions more effectively in the future. As this is a first-time test, there's always a small chance of unexpected risks, although the researchers will be carefully monitoring your safety throughout. You are free to withdraw from the study at any time 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.

Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
Verified postcode
Salford, United Kingdom· Recruiting

Common questions

What are graphene electrodes?

They are new, very thin and flexible sensors made from a special carbon material called graphene. They are designed to sit on the brain's surface to detect tiny electrical signals more clearly.

Why are these new sensors being tested?

Doctors hope these new sensors will give more detailed information about brain activity during surgery, helping them protect important areas like those for speech and movement better than current sensors.

Will my surgery be different if I join this study?

No, you will have your brain tumour surgery as you normally would. The new sensors will be used in addition to the standard equipment during the operation.

What happens after the surgery?

You'll be carefully monitored for any problems, and you'll have an extra MRI scan about six weeks after your operation to check on your recovery and the sensors.

Is it safe to have graphene in my brain?

The primary goal of this study is to carefully test the safety of these graphene sensors during brain surgery for the first time. Your doctors will be monitoring you very closely.

How to find out more

Research Governance, Ethics and Integrity Manager

medicaldevices@manchester.ac.uk +441612752725 Official trial record

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