Active not recruitingOBSERVATIONAL

Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

This global registry is collecting important information about a treatment called ExAblate Neuro. This treatment uses focused sound waves, guided by an MRI scanner, to treat neurological conditions like essential tremor, Parkinson's movement problems, and neuropathic pain. Instead of surgery, it targets specific areas deep in the brain to help reduce symptoms. The study is particularly interested in seeing how safe and effective this treatment is for patients in real-world settings, now that it's been approved for use in certain areas. Doctors are gathering data from around the world to understand its long-term benefits and any potential side effects. It's an observational study, meaning patients receive the treatment as part of their standard care, and researchers then collect information about their progress.

At a glance

Status

Active not recruiting

Sponsor

InSightec

Enrolment target

500

Start

01 Dec 2016

Estimated completion

01 Jun 2026

Essential Tremor Parkinson's Disease Movement Disorders Neuropathic Pain

What is this study about?

This study is a worldwide effort to understand more about a new treatment called ExAblate Neuro. It's a special type of treatment that uses focused sound waves, similar to how a magnifying glass focuses sunlight, to target very small areas deep inside the brain. This is all done without needing to open up the skull, which is a big advantage over traditional brain surgery. An MRI scanner guides the sound waves precisely to the right spot.

The main goal of this study is to gather information on how safe and effective ExAblate Neuro is for people living with certain conditions. These include essential tremor (which causes uncontrollable shaking), movement problems related to Parkinson's disease, and neuropathic pain (which is a type of long-lasting nerve pain). Because the treatment is already approved for use in different countries, this study is like a large-scale check to see how it performs in everyday medical practice.

Researchers are observing patients who receive this treatment as part of their care. They are collecting data to learn more about its benefits, any side effects, and how patients' conditions improve over time. The specific areas in the brain that are targeted, and for which conditions, might vary slightly depending on what has been approved in different countries or regions.

Key takeaways

This study evaluates ExAblate Neuro, a sound wave treatment for brain disorders.
It targets essential tremor, Parkinson's movement problems, and neuropathic pain.
The treatment is guided by MRI and does not require traditional surgery.
It's a global effort to track safety and effectiveness after approval.
Participation involves receiving the treatment and having your progress monitored routinely.

Who may be eligible?

To be considered for this study, you would need to be diagnosed with a condition that ExAblate Neuro is approved to treat in your country or region. Your doctor would check if your specific condition matches the approved uses for this treatment.

Also, a very important part of deciding if this treatment is right for you is whether the focused sound waves can safely reach the area in your brain that needs treatment. Doctors will use special planning tools to make sure the target area is accessible.

You would not be able to join the study if you prefer not to take part, or if there's a reason you wouldn't be able to stay involved and share your health information over a longer 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 diagnosed with essential tremor, Parkinson's movement disorder, or certain neuropathic pain?
Has your doctor said that ExAblate Neuro is an approved option for your condition in your region?
Are you willing for doctors to collect information about your health after receiving the treatment?
Can the treatment safely reach the area in your brain that needs help, as determined by scans?

Answer every question to see your result.

What does participation involve?

If you take part in this registry, you would receive the ExAblate Neuro treatment as advised by your doctor for your specific condition. This isn't a new experimental treatment that hasn't been approved; rather, it’s a treatment that is already available, and the study is gathering more information about its real-world use. The process typically involves an MRI scan before the procedure to plan the treatment, then the procedure itself where the focused sound waves are delivered, guided by real-time MRI.

After your treatment, the study mainly involves collecting information from your routine follow-up appointments. Doctors will monitor your progress, how your symptoms are changing, and check for any side effects. You won't be asked to take extra medication or have additional assessments beyond what would normally be part of your care. The duration of your participation would depend on how long your doctor typically monitors patients receiving this treatment, as the study aims to observe long-term safety and effectiveness.

Potential risks and benefits

The potential benefits of this treatment, as observed in previous studies, include improved control over tremors, reduced Parkinson's movement problems, or relief from neuropathic pain. However, like any medical procedure, there are potential risks, which your doctor will explain in detail. These can include temporary or, rarely, permanent side effects such as numbness, weakness, balance problems, or headaches, although serious complications are uncommon. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (9)

Stanford University
Verified postcode
Stanford, United States
University of Maryland
Verified postcode
Baltimore, United States
University of Pennsylvania
Verified postcode
Philadelphia, United States
University of Virginia
Verified postcode
Charlottesville, United States
Swedish Neuroscience Institute
Verified postcode
Seattle, United States
Sunnybrook
Verified postcode
Toronto, Canada
Rambam Healthcare Campus
Verified postcode
Haifa, Israel
Sheba Medical Center
Verified postcode
Ramat Gan, Israel
Chang Bing Show Chwan Memorial Hospital
Verified postcode
Chang-hua, Taiwan

Common questions

What is ExAblate Neuro?

It's a treatment that uses focused sound waves, guided by an MRI scan, to treat certain brain conditions without needing surgery.

What conditions might this treatment help with?

It's being used for essential tremor, movement problems linked to Parkinson's disease, and some types of nerve pain.

Is this a new, untested treatment?

No, it's a treatment that has already been approved for use in certain areas, and this study is gathering more information about it in real-world settings.

Will I have to do anything extra if I join the study?

You won't have extra appointments or medications. The study mainly collects information from your regular medical check-ups after the treatment.

Can I stop participating in the study if I change my mind?

Yes, you can choose to stop participating at any time, and it will not affect your medical care.