Active not recruitingNAINTERVENTIONAL

Multimodal Connectome Study of Brain Tumor-operated Patients

This study aims to understand how brain tumours affect the way different parts of the brain communicate with each other. Researchers will use special MRI scans (dMRI and fMRI) to look at brain connections before surgery. During surgery, they will also record electrical signals directly from the brain before removing the tumour. By combining all this information, they hope to create a detailed map of brain connections in people with brain tumours. This information could help doctors improve how they remove brain tumours, making future operations safer and more effective, and helping patients recover better.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

12 Dec 2019

Estimated completion

05 Mar 2026

Tumor, Brain

What is this study about?

Imagine your brain is like a complex network of roads connecting different cities. When a brain tumour grows, it can be like a road block or even a detour, changing how these connections work. This study wants to understand exactly how brain tumours affect these 'brain roads' and how the brain tries to adapt or find new routes.

To do this, the study uses special tools. Before surgery, participants will have advanced MRI scans. These scans, called dMRI and fMRI, allow doctors to see the structure of these 'brain roads' and how they function during resting states. Think of it like taking a detailed map of the roads and seeing how traffic flows when there are no major events.

Then, during the actual surgery to remove the tumour, and before the tumour is taken out, doctors will gently record electrical signals directly from the brain. This is like listening to the electrical chatter between different brain areas. By combining these detailed scans and electrical recordings, researchers hope to build a complete picture of how brain tumours impact these vital connections and how the brain might cope, ultimately leading to better and safer ways to treat brain tumours.

Key takeaways

This study explores how brain tumours affect brain connections.
It uses special MRI scans and electrical recordings during surgery.
The goal is to improve future brain tumour surgery and patient recovery.
Participation involves no new treatments or medications.
You can withdraw from the study at any time without impacting your care.

Who may be eligible?

To take part in this study, you must be an adult (18 years or older) with a brain tumour that is going to be removed. You also need to be a member of a social security scheme and be able to understand and give your agreement to participate.

There are certain reasons why you might not be able to join. For example, if you have any medical reasons that prevent you from having an MRI scan, or if you have certain metal objects inside your body like some stents, an eye implant, or a heart pacemaker that isn't safe for MRI. This is for your safety. Also, women who are pregnant or breastfeeding cannot take part, and if you are of childbearing age, a pregnancy test will be done.

Other reasons you might not be able to join include having more than one brain tumour, if you are currently in an emergency situation, or if you are in a situation where you might not be able to make your own decisions freely, such as being under guardianship or in detention. If you decide you don't want to take part, that's also a reason not to join.

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.

Are you 18 years old or older?
Do you have one brain tumour that needs to be removed?
Can you have an MRI scan safely (no unsafe metal implants)?
Are you a member of a social security scheme?
Are you able to understand and agree to take part freely?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have special MRI scans (dMRI and fMRI) before your brain tumour surgery. These scans don't involve any medication; they are just imaging tests. During your brain tumour removal surgery, and before the tumour is taken out, doctors will also record electrical signals directly from your brain using small electrodes. This is done as part of your surgery and won't add extra time or procedures beyond what is normally planned for your operation in terms of tumour removal. All the collected information, including your medical details, scan results, and electrical recordings, will then be carefully studied by the researchers. There are no additional follow-up visits or medication specific to this study after your surgery. The entire duration of your participation in the study involves the pre-operative scans and the recordings during your already planned surgery.

Potential risks and benefits

Taking part in this study could help us better understand how brain tumours affect the brain, which might lead to improved surgical techniques and better recovery for future patients. However, there are no direct benefits to you as an individual in this pilot study, other than contributing to medical knowledge. The procedures involved, such as the MRI scans and the electrical recordings during surgery, are generally safe. The MRI scans carry the usual risks associated with such procedures (e.g., strong magnetic fields), which is why certain medical conditions or implants might prevent you from participating. The electrical recordings are part of a routine protocol during surgery but will be done right before tumour removal. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU de Nice
Verified postcode
Nice, France

Common questions

What is the main goal of this study?

The study aims to understand how brain tumours change brain connections and how the brain adapts, to help improve brain tumour surgery.

Will I receive any new treatment?

No, this study is observational; it uses scans and recordings to gather information, not to provide new treatments.

Will the study add extra time to my surgery?

No, the electrical recordings are done during your planned surgery before the tumour is removed and won't significantly extend the operation time.

Are there any risks to me?

The procedures involve standard MRI scans and recordings during surgery. Risks are similar to those of regular MRI scans, and careful checks are made to ensure your safety.

Can I change my mind about participating?

Yes, you can withdraw from the study at any time without it affecting your medical care.