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Enrolling by invitationNAINTERVENTIONAL

TUS to Disrupt Pathological Oscillations

This study aims to discover if a new, gentle technique called 'Transcranial Focussed Ultrasound' (TUS) can help people with Parkinson's disease. We know that in Parkinson's, certain brain signals, called 'brainwaves,' become overactive. While deep brain surgery can currently help calm these signals, it’s a big operation. We want to see if TUS, which uses sound waves focused on specific brain areas, can reduce these overactive brainwaves without the need for surgery. If successful, this research could pave the way for safer, less invasive treatments for Parkinson's and potentially other brain conditions like chronic pain or memory problems.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
University of Oxford
Enrolment target
30
Start
28 Feb 2024
Estimated completion
09 Jul 2028

What is this study about?

Imagine your brain is like an orchestra, with different parts playing in harmony. In conditions like Parkinson's disease, sometimes one section of the orchestra plays too loudly or out of sync, creating unwanted symptoms. Scientists have noticed that people with Parkinson's often have very strong 'brainwaves' in a specific rhythm, which contribute to their symptoms.

Currently, one effective but invasive treatment involves brain surgery where tiny wires are placed deep inside the brain to help calm these overactive signals. This is a major operation. Our study is looking for a much gentler way to do this using a technology called Transcranial Focussed Ultrasound (TUS).

TUS uses focused sound waves to precisely target and quietly adjust these noisy brain signals, hopefully bringing them back into harmony. We believe this could offer a way to improve Parkinson's symptoms without the need for an operation. If this study is successful, it could open the door to treating not just Parkinson's but also many other brain conditions, such as long-term pain or difficulties with thinking and memory, in a much safer and less invasive way.

Key takeaways

  • Exploring a new, non-surgical treatment for Parkinson's symptoms.
  • Uses gentle sound waves to correct faulty brain signals.
  • Aims to reduce overactive 'brainwaves' linked to Parkinson's.
  • Could be a safer alternative to some existing brain surgeries.
  • May also help research into treatments for other brain conditions.

Who may be eligible?

To join this study, you need to be at least 18 years old. We are looking for people who have Parkinson's disease and already have a specific type of brain implant (Medtronic Percept or similar, or certain temporary electrodes used before surgery) that can measure brain signals. These implants are important because they help us understand how the sound wave treatment is affecting your brain.

You should also be generally well enough to comfortably receive the ultrasound treatment, and your Parkinson's medication should have been stable for at least six weeks before joining. Importantly, we need to be able to see those specific 'noisy' brainwaves mentioned earlier during your initial check-up for the study.

Unfortunately, you can't participate if you have another brain condition that might affect the results, or if you have a fever when you come for your study visit. We also need to be sure you can understand the study information, even with help from an interpreter if needed, as some implants don't work with our measurement tools.

Quick self-check
  • Are you 18 years old or older?
  • Do you have a Medtronic Percept DBS system or similar implant that can measure brain signals?
  • Has your Parkinson's medication been stable for at least 6 weeks?
  • Are you able to understand and agree to participate in the study?
  • Do you feel comfortable trying out a new, gentle ultrasound treatment?

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, you'll have specific study visits. Before the ultrasound treatment, we'll use your existing brain scans (MRI and CT) to map out the exact areas in your brain to target. Then, during the study visits, you will receive two types of focused ultrasound: the 'active' treatment and a 'sham' (dummy) treatment, or treatment to a different brain area, so we can compare the effects. You won't know which one you're getting at the time.

During these sessions, you'll be asked to do some simple tasks, like looking at moving dots or performing motor tasks, while the ultrasound is being applied. We'll also take measurements of your brain activity using your existing implants or external electrodes, and monitor your heart with an ECG.

A doctor will also assess your Parkinson's symptoms during each step, and we'll secretly film these assessments. This footage will later be reviewed by other doctors who don't know when you received the active treatment, helping us get unbiased results. The exact number of visits and the total duration aren't specified but will involve these assessment and treatment sessions.

Potential risks and benefits

Participating in this study might offer you a chance to try a new, non-invasive treatment that could potentially reduce your Parkinson's symptoms without surgery. However, as this is a research study, there's no guarantee that you will personally benefit. Potential risks are generally considered low with transcranial focused ultrasound, but, as with any medical procedure, there could be unforeseen side effects, or it might cause temporary discomfort or dizziness. We will closely monitor you throughout. You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • University of Oxford
    Oxford, United Kingdom

Common questions

What exactly is 'Transcranial Focussed Ultrasound'?

It's a non-invasive technique that uses precise sound waves, aimed at specific areas of your brain, to gently adjust abnormal brain signals without needing surgery.

Why are you studying this for Parkinson's disease?

In Parkinson's, certain brain signals become overactive. We hope that by using ultrasound to calm these signals, we can improve symptoms and offer a safer alternative to existing brain surgery.

Will I know if I'm getting the real treatment or a dummy treatment?

No, you won't know at the time. This helps us ensure the study results are as fair and accurate as possible, as knowing could change your experience.

What kind of brain implant do I need to have?

You need to have a specific type of Deep Brain Stimulation (DBS) system, like Medtronic Percept, or special temporary electrodes, that can measure brain signals.

What happens if I decide I don't want to continue?

You can leave the study at any point, for any reason, and it will not affect your usual medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "TUS to Disrupt Pathological Oscillations…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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