RecruitingNAINTERVENTIONAL

3T MRI in Patients With Deep Brain Stimulation (DBS)

This research is looking into how Deep Brain Stimulation (DBS), a treatment for conditions like Parkinson's and severe tremor, affects the brain. We use advanced MRI scanners, called 3T MRI, which provide very detailed pictures of the brain. Specifically, we'll be using a type of MRI called fMRI to observe how brain activity changes when DBS is turned on or off. The goal is to understand how DBS works inside the brain and to see if these new, high-quality scans can help doctors fine-tune DBS treatment and improve care for patients. This study will involve people who already have or are about to receive DBS implants for various brain-related health issues.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

250

Start

01 Jun 2017

Estimated completion

01 Dec 2030

Neuro-Degenerative Disease

What is this study about?

This research study is all about understanding how a treatment called Deep Brain Stimulation (DBS) works inside the brain. DBS is a well-established treatment for several health conditions, including advanced Parkinson's disease, severe tremors that don't respond to medicine, and certain other neurological and psychiatric disorders. While we know DBS can be very effective, exactly how it changes brain activity to improve symptoms is still being studied. This research aims to shed more light on that process.

To do this, we are using very advanced MRI (Magnetic Resonance Imaging) scanners, specifically ones known as 3T MRI. These scanners provide much clearer and more detailed pictures of the brain compared to older MRI machines. We'll be focusing on a special type of MRI called fMRI (functional MRI), which can show us brain activity in real-time. By using fMRI, we plan to see how different parts of the brain respond when DBS is turned on or off in patients.

The main goal is to see if these high-tech scans can give doctors a better understanding of how DBS affects the brain's structure and function. Ultimately, we hope to find out if using these advanced MRI techniques can help healthcare professionals to improve DBS treatment and provide even better care for patients. This could mean fine-tuning the settings of the DBS device more effectively for each individual.

Key takeaways

This study uses advanced MRI scans to understand how DBS affects the brain.
It aims to improve DBS treatment for conditions like Parkinson's disease.
Participation involves undergoing specialized brain scans with a DBS device.
The research will investigate brain activity when DBS is switched 'on' and 'off'.
It's for research purposes and may not offer direct personal health benefits.

Who may be eligible?

To join this study, you need to be an adult between the ages of 18 and 85. You must either be scheduled to have a Deep Brain Stimulation (DBS) device implanted soon, or you may have already had one put in.

It's really important that you can understand what the study is about and what is being asked of you, so you'll need to be able to read and sign an informed consent form. We also need you to understand that this study is for research purposes, meaning it's to help us learn more about how the brain works with DBS, rather than directly benefiting your health in this specific study.

We cannot include people who have serious issues with their memory or thinking that would prevent them from understanding the study or giving their consent. Also, if you have difficulty speaking clearly or don't speak English, you might not be able to participate.

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 between 18 and 85 years old?
Are you scheduled for or have you already had a DBS device implanted?
Can you understand and sign a consent form for research?
Do you understand that this study is primarily to learn about DBS, not for direct personal benefit?
Do you communicate effectively in English and do not have severe thinking or speaking difficulties?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have several specialized MRI scans of your brain. These scans will use advanced 3T MRI technology, including a functional MRI (fMRI) which looks at brain activity. You may have scans taken when your DBS device is switched off and when it is switched on. Before your scans, some safety checks will be performed to ensure it is safe for you to be in the MRI scanner with your DBS device. You won't have to take any new medications just for this study. The total duration of your participation will depend on when your scans are scheduled, but each scanning session will take a specific amount of time. There are no additional follow-up visits specifically for this study beyond your usual medical appointments.

Potential risks and benefits

The potential benefits of joining this study include contributing valuable information that could improve DBS treatment for future patients and potentially for yourself, as well as gaining a deeper understanding of how DBS affects the brain. The main risk involves undergoing fMRI scans while your DBS device is active, though preliminary safety tests have been conducted. There are no known direct health risks specific to the scanning conditions. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Toronto Western Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Deep Brain Stimulation (DBS)?

DBS is a treatment where small devices are surgically placed in specific areas of the brain to send electrical signals, helping to control symptoms of conditions like Parkinson's disease or severe tremor.

What is a 3T MRI and fMRI?

A 3T MRI is a powerful scanner that takes very detailed pictures of the brain. fMRI is a special type of MRI that shows how active different parts of your brain are, helping us see how it's working.

Will I get any personal benefit from this study?

The main aim of this study is research, meaning it's to help us learn more about DBS. While your participation will help advance medical knowledge, there's no guarantee of direct personal health benefits from taking part.

Is it safe to have an MRI with my DBS device?

Experienced staff will ensure all safety precautions are taken. We have already done safety tests in models to make sure these specific experimental conditions are safe for people with DBS devices.

How long will my participation last?

Your involvement will include specific scanning sessions. The clinic will tell you exactly how long each session will take.

How to find out more

Alexandre Boutet, MD/MSc

alexandre.boutet@mail.utoronto.ca (647) 463-5513 Official trial record

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