RecruitingInterventional

Phase-locked brain stimulation for people with Parkinson's disease

Researchers at the University of Oxford are studying a new approach to deep brain stimulation (DBS) for people with Parkinson's disease. DBS is a treatment where small electrical pulses are sent to specific brain areas. This study, called `phase-locked` brain stimulation, aims to make DBS even more effective by carefully timing these electrical pulses to match your brain's natural rhythms. They are testing a flexible and stable system to deliver this new type of stimulation. The main goals are to check if it's safe, how it affects brain waves, and if it can help improve movement, like reducing slow movements. Participants will do simple tasks while receiving different types of stimulation to compare the results.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

Start

01 Oct 2023

Estimated completion

30 Sep 2028

People undergoing deep brain stimulation (DBS) surgery

What is this study about?

This study is looking into a new way to use deep brain stimulation (DBS) for people living with Parkinson's disease. DBS is a treatment where a small device is put inside the body to send electrical signals to specific parts of the brain. Usually, these signals are sent continuously. However, this study is exploring a more precise technique called `phase-locked` stimulation.

Imagine your brain has natural rhythms, like waves. The idea behind `phase-locked` stimulation is to time the electrical pulses from the DBS device to match these brain wave rhythms perfectly. The researchers believe that by syncing the stimulation to your brain's own timing, they might be able to make the treatment work even better to improve symptoms of Parkinson's, such as slow movement (bradykinesia).

In this study, researchers will test a new system designed to deliver this `phase-locked` stimulation. They will compare it with standard DBS and with no stimulation at all. By doing simple tasks like tapping fingers or maintaining a posture, they will carefully watch how your brain and muscles react. This will help them understand if this new, timed stimulation is effective, safe, and can lead to better control over movement.

Key takeaways

Exploring a new way to make Parkinson's Deep Brain Stimulation (DBS) more effective.
Aims to time DBS electrical pulses with the brain's natural rhythms.
Involves simple tasks and testing different stimulation settings.
Participation will not affect your usual medical care.
Small risk of temporary sensations like tingling, or temporary symptom worsening if medication is paused.
Study is taking place at the University of Oxford.

Who may be eligible?

This study is looking for people who are aged 18 or older and are already receiving deep brain stimulation (DBS) treatment for Parkinson's disease. This means you must have had the DBS electrodes implanted.

However, there are some reasons why someone might not be able to join. If you've had any serious complications after your first DBS surgery, like bleeding in the brain or confusion, you wouldn't be able to take part. Also, if a doctor thinks you wouldn't be able to understand the study well enough to give your permission (consent), or if you couldn't do the simple tasks required for the study, you wouldn't be eligible. They might do a quick test to check your memory and thinking skills if there are any concerns.

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 already have Deep Brain Stimulation (DBS) electrodes implanted?
Have you had any serious complications after your last DBS surgery?
Can you understand information about the study and give your permission to take part?
Are you able to do simple movement tasks without difficulty?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to change your usual Parkinson's medication for the study itself, though you might be asked to briefly pause it just for the morning of the study, similar to missing a dose. The main part of your involvement will be a session lasting up to two hours at the University of Oxford. During this session, researchers will set up different stimulation levels using your existing DBS device.

You'll be asked to do some simple movement tasks, such as tapping your fingers or holding a steady position with your eyes closed. Meanwhile, the researchers will be recording signals from your brain and muscles. They will test how you perform these tasks under three different conditions: with your usual DBS turned on, with this new `phase-locked` DBS, and with no stimulation. This helps them compare the different approaches and see if the new method is more effective. Taking part in this study will not affect the usual medical care you receive.

Potential risks and benefits

Participating in this study will not affect your regular medical care for Parkinson's. The researchers don't expect any serious harm from being involved, and the tests like brain and muscle recordings are not invasive. There's a small chance you might feel a temporary tingling, cramping, or your speech might be slightly slurred during the stimulation, but these should go away quickly. If you pause your medication for the study, you might temporarily experience a mild worsening of your Parkinson's symptoms, similar to forgetting a dose. You are always free to withdraw from the study at any time without explanation, and this will not affect your future medical care. While there's no direct personal benefit guaranteed, your participation could help researchers develop better treatments for Parkinson's disease in the future.

Locations (1)

University of Oxford
Approximate
Oxford, United Kingdom

Common questions

What is `phase-locked` brain stimulation?

`Phase-locked` brain stimulation is a new way to deliver electrical pulses from a DBS device. Instead of sending continuous pulses, it times them to match your brain's natural rhythms, hoping to make the treatment more effective.

Will I have to stop my Parkinson's medication?

No, you don't typically have to stop your medication. If asked to, it would only be for a brief time on the morning of the study, similar to missing one dose, and your symptoms might temporarily worsen.

What will I actually have to do in the study?

You'll do simple movement tasks like finger tapping or holding a posture while researchers adjust your DBS settings and record your brain and muscle activity. This helps them see how the different stimulation methods affect you.

Are there any risks to taking part?

The researchers don't expect serious harm. There's a small chance of temporary tingling, cramping, or slurred speech from the stimulation. If you miss medication, your symptoms might temporarily worsen slightly.

How long will the study go on for?

This study started in October 2020 and is expected to run until September 2028. Your individual participation would involve a single session lasting up to two hours.

How to find out more

Huiling Tan

huiling.tan@ndcn.ox.ac.uk +44(0)1865 572483 Official trial record

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