RecruitingOBSERVATIONAL

Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS

This study is gathering information about a medical treatment called radiofrequency ablation (RF ablation) when it's used for conditions affecting the brain and nervous system, such as Parkinson's disease, dystonia, and essential tremor. Instead of testing a new treatment, the researchers are looking at how well Boston Scientific's RF ablation systems work in people who are already receiving this treatment as part of their regular care. The main goal is to understand the real-world results and benefits of this procedure in functional neurosurgery. This will help doctors and patients understand more about how effective this treatment can be for these types of movement disorders and pain.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

200

Start

29 Jan 2024

Estimated completion

01 Dec 2035

Parkinson Disease Dystonia Essential Tremor Movement Disorders

What is this study about?

This study is all about understanding how well a specific type of treatment called radiofrequency (RF) ablation works for certain conditions that affect the brain and how we move. These conditions include things like Parkinson's disease, dystonia (which causes muscle spasms), and essential tremor (which causes shaking).

Instead of testing a brand new treatment, this research is collecting information from people who are already having this RF ablation treatment as part of their standard medical care. RF ablation uses heat to target very small, specific areas in the brain that are causing symptoms. The researchers are particularly interested in how devices made by Boston Scientific, which are already approved for use, perform in real-world situations, not just in a research setting. They want to see what outcomes people experience, like how much their symptoms improve.

The main reason for doing this study is to gather information that shows how effective RF ablation is in helping people with these conditions. By collecting 'real-world' results, doctors can get a clearer picture of the benefits and how this treatment can improve quality of life for patients undergoing functional neurosurgery.

Key takeaways

This study collects real-world results of an approved brain treatment.
It focuses on Parkinson's, dystonia, and essential tremor.
Researchers want to understand how effective radiofrequency ablation is.
Participation fits into your existing treatment plan.
No new treatments are being tested; it's about existing care.

Who may be eligible?

To be part of this study, you would need to be scheduled to receive treatment using a specific type of medical device called a Boston Scientific RF system. This treatment would be either for pain or for conditions specifically affecting the brain and nervous system.

You also need to understand what the study involves and agree to take part by signing a consent form. This form ensures you have all the information you need and agree to share your treatment information.

You would not be able to join if your doctor believes the RF treatment isn't suitable for you based on medical guidelines. Also, if you have memory problems or any other condition that would make it difficult for you to understand study questions or talk about your pain relief, you wouldn't be able to participate.

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 scheduled for a Boston Scientific RF ablation procedure?
Will this procedure be for pain or a brain/nervous system condition?
Can I understand and sign a consent form?
Do I have any problems with memory or understanding that would make it hard to answer questions?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be doing anything different from your planned medical treatment. You will receive your radiofrequency ablation procedure as scheduled by your doctor. The study basically involves the research team collecting information about how you respond to this procedure over time. This includes details about your condition before the treatment, during the procedure, and afterwards. You may be asked to complete questionnaires about your symptoms and how much relief you feel. The total duration of your participation will depend on how long your doctor typically monitors your condition after this type of treatment, but it will fit in with your usual follow-up appointments.

Potential risks and benefits

The main benefit of this study is that it helps doctors learn more about how well radiofrequency ablation works for conditions like Parkinson's disease in real life. This information can help improve treatments for others in the future. As you would already be having this procedure, participating in the study doesn't add new medical risks beyond those of the treatment itself, which your doctor will explain thoroughly. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (4)

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

Uniklinik Köln
Verified postcode
Cologne, Germany· Recruiting
Universitaetsklinikum Dusseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Universitaetsklinikum Wuerzburg
Verified postcode
Würzburg, Germany· Recruiting
St. Georges Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is radiofrequency (RF) ablation?

It's a medical procedure that uses heat to target and treat small, specific areas in the brain or nervous system that are causing symptoms.

Is this study testing a new treatment?

No, this study is looking at how well an existing, approved treatment (RF ablation) works for people in their everyday medical care.

What kind of conditions is this study looking at?

It's focused on conditions affecting the brain and movement, such as Parkinson's disease, dystonia, and essential tremor.

Do I have to do anything extra if I join?

You'll have your planned medical treatment as usual. The study team will mainly collect information about your progress and may ask you to complete some questionnaires during your regular follow-up visits.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any time, and it won't affect your medical care.

How to find out more

Stephanie Delvaux

BSNClinicalTrials@bsci.com 855-213-9890 Official trial record

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