Active not recruitingNAINTERVENTIONAL

Towards Noninvasive DBS of the Basal Ganglia in Parkinson's Disease Using TUS

This research is exploring a new brain stimulation method called Transcranial Ultrasound Stimulation (TUS) for people living with Parkinson's disease or dystonia. TUS uses sound waves to precisely target areas deep inside the brain, similar to how Deep Brain Stimulation (DBS) works, but without needing surgery. For this study, tiny wires already placed in the brain as part of a previous DBS surgery will help scientists measure brain activity. They want to see how TUS affects these brain signals and if it could be a new, less invasive treatment option in the future. The study will compare different types of TUS and a 'dummy' treatment to better understand its effects.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Aug 2023

Estimated completion

31 Dec 2026

Parkinson Disease Dystonia

What is this study about?

This study is investigating a new and gentle way to stimulate the brain called Transcranial Ultrasound Stimulation, or TUS. For people with conditions like Parkinson's disease or dystonia, there's a treatment called Deep Brain Stimulation (DBS) that uses small electrical pulses to help control symptoms. TUS aims to do something similar using sound waves instead of electricity. The exciting thing about TUS is that it doesn't involve surgery to place electrodes and can target specific, deep areas of the brain very accurately.

In this particular study, the researchers want to understand how TUS works inside the brain. They are inviting people who already have DBS devices implanted for their Parkinson's disease or dystonia. While the DBS device will be temporarily switched off, the existing wires in the brain will allow researchers to listen in on brain activity before, during, and after TUS. This helps them see exactly what TUS does to the brain and how it might help improve symptoms.

The main goal is to compare the effects of this new TUS method with what we already know about DBS. By understanding how TUS changes brain activity, scientists hope to develop it into a valuable, less invasive treatment option for movement disorders in the future.

Key takeaways

A study using sound waves (TUS) to stimulate the brain.
For people with Parkinson's or dystonia who already have DBS.
Aims to understand how TUS affects brain activity.
Could lead to new, non-surgical treatment options.
Involves 3 visits: an MRI scan and two TUS sessions.
Your DBS will be off during the TUS treatments.

Who may be eligible?

This study is looking for adults who have a diagnosed movement disorder, like Parkinson's disease or dystonia, and have previously had a Deep Brain Stimulation (DBS) system called 'Percept PC' implanted at least one month ago. You also need to have been on a steady dose of your usual Parkinson's medication for at least four weeks.

There are some reasons why you might not be able to join. For example, if you have other conditions like a stroke, seizures, severe memory problems, or major depression. You also won't be able to participate if you have a pacemaker, an implantable heart device, or other metal implants in your head (apart from your DBS system) that are not safe for MRI scans.

Finally, if you've had brain surgery that involved making a controlled injury to brain tissue (a 'lesion procedure'), or if you have a serious illness, an infection, or are pregnant, you won't be able to take part in this study.

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 an adult with a movement disorder diagnosis?
Do you have a Percept PC DBS system implanted for at least one month?
Has your Parkinson's medication dose been stable for at least 4 weeks?
Do you *not* have other serious neurological or psychiatric conditions?
Do you *not* have any other unsafe implants or major illnesses?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have three different visits over a few weeks. The first visit will involve having a special type of brain scan called an MRI at a hospital in Toronto. This scan helps the researchers accurately plan where to direct the sound waves for your treatment.

During the second and third visits, you'll have the TUS treatment. You'll have tiny wires already in your brain (from your DBS surgery) that will help the researchers record brain activity. During these visits, your own DBS device will be switched off. The researchers will use different patterns of sound waves, and you'll also have 'sham' treatments, which are like dummy treatments or involve stimulating a different part of the brain, to help understand the true effects of TUS. These two visits will be at least a week apart. The whole process, including the visits and the time between them, will likely span a few weeks.

Potential risks and benefits

There is a possibility that taking part in this study could offer you an early opportunity to experience a new type of brain stimulation, which might lead to a better understanding of your condition. However, the main benefit of this study is to help future research, and it's not guaranteed to directly improve your symptoms. Potential risks of TUS are generally mild, such as a sensation on the skin or a headache, but the researchers will carefully monitor you for any effects. You have the right 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

Common questions

What is TUS?

TUS stands for Transcranial Ultrasound Stimulation. It's a new way to stimulate the brain using sound waves, without needing an operation.

Will my DBS device be on during the study?

No, your implanted DBS device will be switched off during the TUS sessions in this study.

Why do I need an MRI scan?

The MRI scan helps the researchers make a very precise map of your brain, so they know exactly where to direct the sound waves for the TUS treatment.

What is a 'sham' treatment?

A 'sham' treatment is like a dummy treatment. It helps researchers compare the real effects of TUS with what might happen purely from the experience of having the treatment.

Will I feel anything during TUS?

You might feel a mild sensation on your head during the TUS treatment, but it should not be painful.