RecruitingOBSERVATIONAL

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

This study, called a registry, is following people who have already had a treatment called unilateral thalamotomy using the Exablate Neuro system. This treatment is for Parkinson's disease where tremor is the main problem and medicines haven't helped enough. The main goal is to collect long-term information about how safe and effective this treatment is. Researchers will check on patients at different times over five years, from their first treatment onwards. They will look at how well the tremor is controlled, if there are any side effects, and how it affects daily life. This helps us understand the real-world impact of this treatment for people in the UK.

At a glance

Status

Recruiting

Sponsor

InSightec

Enrolment target

Start

28 Apr 2022

Estimated completion

01 Dec 2027

Tremor Associated With Tremor Dominant Parkinson's Disease

What is this study about?

Imagine you have Parkinson's disease, and one of your biggest challenges is a tremor that shakes parts of your body. You've tried different medicines, but they just aren't helping enough. This study is about a special treatment called Exablate Neuro, which uses focused ultrasound waves. This treatment aims to help reduce severe tremor that medicines can't control.

This isn't a new experimental treatment, but rather a way for doctors and researchers to keep track of how people are doing after they've had the Exablate Neuro procedure. It's called a 'registry' because it's collecting information from people who have already received this treatment as part of their regular care. The main reason for this study is to gather long-term details about how safe and effective the Exablate Neuro treatment is for tremors caused by Parkinson's disease, especially when those tremors are very difficult to manage with medication alone.

By carefully collecting information over many years, including details about any side effects and how much the tremor improves, this study helps everyone understand the real-world benefits and any potential challenges of this treatment. This information is very valuable for future patients and doctors when deciding on the best course of action for tremor in Parkinson's disease.

Key takeaways

This study is a registry, collecting long-term information on an approved tremor treatment.
It's for people with Parkinson's tremor that hasn't responded to medication.
Participants will have already received the Exablate Neuro treatment.
The study aims to understand the treatment's safety and effectiveness over five years.
You'll need to attend regular follow-up appointments and complete questionnaires.
Your participation helps improve understanding for future patients.

Who may be eligible?

To be part of this study, you need to be a man or woman aged 30 or older. You should have already had the Exablate Neuro procedure to treat your severe tremor caused by Parkinson's disease, as decided by your regular medical team.

It's important that you are willing and able to cooperate with all the study's requirements. This includes attending all the follow-up appointments and completing any forms or assessments they ask for. You'll also need to sign a consent form, which means you understand what the study involves and agree to take part.

You won't be able to join the study if you don't want to participate, or if there's a reason you might not be able to complete all the necessary check-ups and visits over the study period.

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 30 years old or older?
Have you already had the Exablate Neuro procedure for your tremor?
Are you willing to attend regular check-ups and complete forms for five years?
Are you able to sign a consent form that explains the study fully?

Answer every question to see your result.

What does participation involve?

If you take part in this registry, it means the study team will collect information about your health and tremor over several years. You will have already had the Exablate Neuro treatment before joining. The team will want to see you for follow-up visits at 1, 3, 6, and 12 months after your procedure, and then once a year for the next five years.

During these visits, they will ask about any side effects you might have had since your last visit. They will also note down any medications you are taking. You'll complete some questionnaires and have some assessments to measure your tremor and how it affects your daily life. These assessments help the doctors understand how well the treatment is working and how you are feeling generally. The total duration of follow-up for this study is five years.

Potential risks and benefits

The main benefit of participating in this study is that the information collected will help doctors and other patients understand more about the long-term safety and effectiveness of the Exablate Neuro treatment for Parkinson's tremor. While the treatment itself carries some risks, which your doctor would have discussed with you before your procedure, taking part in this registry mainly involves giving permission for your health information to be collected. There are generally very few risks to simply having your data recorded, but the study team will monitor for any new side effects after your treatment. Remember, you have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (8)

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

Miami Neuroscience Institute Baptist Health
Verified postcode
Miami, United States· Recruiting
Rush University
Verified postcode
Chicago, United States· Recruiting
Brigham and Women's Hospital
Verified postcode
Boston, United States· Recruiting
Weill Cornell Medicine
Verified postcode
New York, United States· Recruiting
Novant Health Brain & Spine Surgery
Verified postcode
Huntsville, United States· Recruiting
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
Miami Valley Hospital
Verified postcode
Fairborn, United States· Recruiting
University of Dundee
Verified postcode
Dundee, United Kingdom· Recruiting

Common questions

What is the Exablate Neuro treatment?

It's a special procedure that uses focused ultrasound waves to help reduce severe tremor in some people with Parkinson's disease when medicines haven't worked well enough.

Why is this study happening if the treatment is already approved?

Even after a treatment is approved, studies like this (called registries) help gather more long-term, real-world information about its safety and how well it works for patients over many years.

Will I get the Exablate Neuro treatment as part of this study?

No, this study is for people who have already had the Exablate Neuro treatment before they join the registry. It's about tracking their progress afterwards.

How often will I need to visit the clinic?

You'll have follow-up visits at 1, 3, 6, and 12 months after your Exablate procedure, and then once a year for five years after that.

What kind of information will they collect?

They'll ask about any side effects, your medications, and you'll complete some forms and assessments to measure your tremor and how you're feeling overall.

How to find out more

Matt Hibert

clinicalresearchquestions@insightec.com 214-630-2000 Official trial record

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