RecruitingOBSERVATIONAL

DBS and Respiration

This study investigates if a common treatment for Parkinson's disease, called deep brain stimulation (DBS), can sometimes lead to breathing problems. Doctors have noticed that some patients experience breathlessness after DBS, particularly when a part of the brain called the subthalamic nucleus (STN) is stimulated. The main goal is to find out if this connection is real and, if so, what causes it. We'll be looking at how breathing feels to patients, their lung function, and daily activity levels. Patients having DBS surgery for Parkinson's or other neurological conditions will be invited to take part. This research could help improve care for people with Parkinson's in the future.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

Start

01 Apr 2021

Estimated completion

21 Sep 2026

Parkinson Disease

What is this study about?

Deep Brain Stimulation (DBS) is a common and safe treatment for certain long-term conditions like Parkinson's disease. It involves placing small electrical devices in specific parts of the brain to help manage symptoms. Many patients referred for this surgery experience good results.

Doctors have sometimes noticed that people who have DBS in a particular brain area, called the subthalamic nucleus (STN), can experience breathing difficulties or feel breathless. This study aims to understand if these breathing issues are directly caused by the DBS treatment in this area. It's really important to verify this observation and then figure out why it might be happening.

To do this, researchers will look at how breathing works and feels both before and after DBS surgery. They'll also check daily physical activity levels and use brain scans to see if there are any links between brain structure and breathing changes. The information gathered could help doctors better understand the effects of DBS and provide even better care for people with Parkinson's in the future.

Key takeaways

This study investigates if DBS for Parkinson's disease can affect breathing.
It aims to understand why some patients might feel breathless after DBS in a specific brain area.
Participation involves breathing tests, questionnaires, and wearing an activity tracker before and after DBS surgery.
Your standard DBS surgery will not be changed by joining the study.
The research could help improve how doctors care for future Parkinson's patients.
You can choose how much you participate and can leave the study at any time.

Who may be eligible?

You might be able to join this study if you are 18 years or older, can speak English, and are already planning to have DBS surgery. If you have Parkinson's disease and are having DBS, you would be in the main study group.

However, there are some reasons why you wouldn't be able to join. For example, if you are pregnant, or if you are already taking part in another medical study that involves a treatment that could affect your breathing. Also, if you have a current breathing problem, like a bad cold, flu, or a flare-up of asthma, at the time of the study tests, you wouldn't be able to participate at that moment.

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 aged 18 or over?
Do you speak English fluently?
Are you already scheduled to have DBS surgery?
If you have Parkinson's, are you having DBS for this condition?
Are you currently pregnant? (If so, you cannot join)
Do you have a current cold, flu, or asthma flare-up?
Are you in another study where a treatment might affect your breathing?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to complete some questionnaires about your breathing and undergo tests of how you sense your breathing and how well your lungs are working. These assessments will happen before your DBS surgery. After your surgery, you will have these same tests again. During the post-surgery tests, we will check your breathing both when your DBS device is switched on and when it's temporarily switched off, to see how your body responds.

Throughout these periods (before and after surgery), you'll also wear a special device, like a smartwatch, to track your daily activity, such as your steps and heart rate. You'll be invited to do all parts of the study, but you can also choose to do fewer activities if you prefer. The total duration of your involvement will depend on your pre- and post-operative assessment schedule.

Potential risks and benefits

By taking part in this study, you won't directly receive a new treatment, as you would already be undergoing DBS as part of your standard medical care. However, the information gathered could help doctors gain a better understanding of how DBS affects breathing, which may lead to improved care for future patients with Parkinson's disease. There are minimal risks involved, mainly related to the time commitment for tests and wearing a monitoring device. You are free to withdraw from the study at any time without affecting your medical treatment or 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 is a medical procedure where small devices are surgically placed in specific areas of the brain to send electrical signals. This can help control symptoms of conditions like Parkinson's disease.

Why are researchers looking at breathing?

Some doctors have noticed that breathing problems, like feeling breathless, can sometimes happen after DBS, especially in a specific brain area. This study aims to find out if there's a direct link and why.

Will my DBS surgery be different if I join?

No, your DBS surgery will be exactly the same as planned. This study only involves extra tests and questionnaires around the time of your surgery.

What does 'stimulation ON and OFF' mean for the tests?

After your surgery, during some tests, your DBS device will be temporarily switched on for some measurements and then temporarily switched off for others. This helps researchers compare the effects.

Do I have to do all the study activities?

You'll be offered the full study, but you can choose to participate in a smaller number of activities if that suits you better.

How to find out more

Alex Green, FRCS

alex.green@nds.ox.ac.uk 01865227645 Official trial record

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