RecruitingNAINTERVENTIONAL

Frontosubthalamic Networks in Parkinson's Disease.

This study is investigating why some people with Parkinson's disease who have deep brain stimulation (DBS) might experience an increase in impulsive behaviours. Researchers want to understand how DBS in a specific part of the brain called the subthalamic nucleus changes brain activity. They aim to find out if these brain changes are linked to increased impulsivity and if adjusting the DBS settings could help prevent or reduce these impulsive tendencies. Participants will perform decision-making tasks while their DBS device is switched on and off, and their brain activity will be measured using a special non-invasive scanner called magnetoencephalography (MEG).

At a glance

Status

Recruiting

Phase

Sponsor

University of Oxford

Enrolment target

Start

01 Jun 2024

Estimated completion

31 Aug 2026

Parkinson Disease Impulse Control Disorder

What is this study about?

This study aims to understand certain changes that can happen in the brain when someone with Parkinson's disease receives deep brain stimulation (DBS). Specifically, we're focusing on some people who have DBS in a brain area called the subthalamic nucleus (STN) and have noticed an increase in impulsive behaviours. Impulsivity means acting on sudden urges without thinking about the consequences, and it can sometimes be a side effect for people with Parkinson's, especially after certain treatments.

Researchers want to see exactly how DBS affects the brain's networks – think of these as the brain's communication highways. They are particularly interested in whether specific changes in these networks are connected to people becoming more impulsive. By understanding these connections, the study hopes to find ways to reduce or prevent this side effect. Could adjusting the DBS settings to a different pattern help keep impulsive behaviours in check?

To figure this out, you would be asked to do some simple decision-making tasks. While you're doing these tasks, your DBS device would be briefly turned on and off at different times. At the same time, we would use a non-invasive brain scanner called magnetoencephalography (MEG) to measure your brain activity in real-time. This helps us see how your brain is working differently when the DBS is on versus off, and how that relates to your choices.

Key takeaways

This study explores how DBS for Parkinson's affects brain activity and impulsivity.
It uses a non-invasive brain scan (MEG) while DBS is turned on and off.
The goal is to find ways to reduce impulsive side effects related to DBS.
Participation involves one visit and temporarily delaying Parkinson's medication.
Results could help improve future DBS treatments for Parkinson's patients.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has been diagnosed with Parkinson's disease and already has a deep brain stimulation (DBS) device implanted in the STN area. Your doctor will have decided you need DBS in addition to your usual Parkinson's medication. You might be eligible whether or not you have experienced impulsive behaviours since your Parkinson's diagnosis. It's important that you can understand the study's purpose and are happy to give your permission to take part.

You must also be able to sit comfortably in the MEG scanner and follow instructions. For the study, you'll need to be willing to delay your morning dose of Parkinson's medication for up to four hours, which includes travel time to the study centre and the experimental time itself. This is important for us to see how your brain responds without the immediate effect of your morning medication.

However, some things would mean you couldn't take part. If you have other implanted medical devices that might interfere with the MEG scanner (like certain pacemakers), or if you have other brain disorders, this study might not be suitable. Also, if you're already in another neurological study that could affect our results, or if you have severe language barriers, or if sitting still for the MEG scan is difficult due to conditions like chronic pain, you might not be able to participate. Your main doctor will help us check if you can sit comfortably for the scan.

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.

Am I 18 years old or older?
Do I have Parkinson's disease and an implanted STN DBS device?
Can I understand the study information and give my consent?
Am I able to sit still and comfortably in a scanner for a period of time?
Am I able to delay my morning Parkinson's medication for up to 4 hours on the study day?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would attend a single study visit. During this visit, you would undergo a specialised brain scan called magnetoencephalography (MEG). While in the MEG scanner, you would complete a series of decision-making tasks. Throughout these tasks, your deep brain stimulation (DBS) device would be temporarily switched on and off at different times, as directed by the study team. You would also need to delay your morning dose of Parkinson's medication for up to four hours on the day of the study. There is no specific follow-up required after this single visit. The total duration of your active participation in the study, including preparation and scanning time, would be approximately one day.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather could help us understand Parkinson's disease and DBS better, potentially leading to improved treatments for others in the future, especially regarding impulsive behaviours. The main risks involve potential discomfort from delaying your morning medication or sitting still in the MEG scanner. Also, changes to your DBS settings during the study are temporary and will be carefully managed by medical professionals. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

John Radcliffe Hospital
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is deep brain stimulation (DBS)?

DBS involves surgically implanting small wires into specific areas of the brain to deliver electrical impulses, which can help control symptoms of Parkinson's disease.

What is 'impulsivity'?

Impulsivity means acting quickly on urges or desires without fully considering the potential consequences. For example, excessive gambling or shopping.

What is a MEG scan?

MEG stands for magnetoencephalography. It's a safe, non-invasive scan that measures tiny magnetic fields produced by brain activity, helping us see how your brain is working in real time.

Will my DBS settings be changed permanently?

No, any changes to your DBS settings during the study are temporary and will be reversed after the tasks are complete. Your usual settings will be restored.

Do I have to have experienced impulsivity to join?

No, you can join the study whether or not you have experienced impulsive behaviours since your Parkinson's diagnosis. We need both groups to compare.

How to find out more

John Eraifej, BSc MBChB MRCS

john.eraifej@ndcn.ox.ac.uk 01865222763 Official trial record

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