ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
This study is testing a new treatment called ExAblate Pallidotomy for people with advanced Parkinson's disease whose symptoms, such as uncontrolled jerky movements (dyskinesia) or sudden changes between being able to move and being stiff ('motor fluctuations'), are no longer well-controlled by their usual medicines. The treatment uses highly focused sound waves to target a specific tiny area in the brain without needing major surgery. The goal is to see if this method is safe and effective in improving these difficult symptoms. Participants will either receive the active treatment or a 'sham' treatment, which mimics the procedure but without the active sound waves, to fairly compare its effects.
At a glance
What is this study about?
This research study is investigating a new treatment approach called 'ExAblate Pallidotomy' for people living with advanced Parkinson's disease. We know that as Parkinson's progresses, some people experience challenging symptoms like dyskinesia – these are involuntary, jerky, or writhing movements – or 'motor fluctuations', which means they can switch suddenly between periods where their medication works well and they move easily ('on' periods), and periods where medication doesn't work and they become stiff and slow ('off' periods). These symptoms can be very disruptive, even when patients are on their best possible medication regimen.
The ExAblate Pallidotomy uses highly focused ultrasound waves. Think of it like focusing sunlight through a magnifying glass: it directs energy very precisely to a tiny target. In this case, the target is a small, specific area in the brain. The idea is to gently change this area with sound waves without needing to make any cuts or holes in the head, which is different from traditional brain surgery. By altering this small part of the brain, researchers hope to reduce the uncontrolled movements and improve the 'on' periods for people with Parkinson's.
The main aim of this study is to find out if this focused ultrasound treatment is both safe and works effectively to help manage these difficult Parkinson's symptoms. By gathering this information, researchers hope to offer a new option for people whose Parkinson's symptoms are no longer adequately controlled by medications alone.
Key takeaways
- Tests a new non-surgical treatment for advanced Parkinson's symptoms.
- Aims to reduce uncontrolled movements (dyskinesia) and 'on-off' periods.
- Uses focused sound waves to target a small brain area.
- Participants will receive either active treatment or a 'sham' treatment.
- Requires stable Parkinson's medication doses before starting.
- Study involvement lasts for 12 months.
Who may be eligible?
To be part of this study, you need to be at least 30 years old and have been diagnosed with Parkinson's disease by a specialist doctor. Your Parkinson's symptoms, like uncontrolled movements or 'on-off' periods, should not be getting better with your current medication, and you should have responded well to levodopa medication in the past. It's also important that you've been on a steady dose of your Parkinson's medications for at least a month before the study starts.
There are also some reasons why you wouldn't be able to join. For example, if you have other brain conditions that can be mistaken for Parkinson's, like Dementia with Lewy Bodies, or if you've had certain brain surgeries before, such as deep brain stimulation. You also can't have serious memory problems or unstable mental health conditions, like severe depression or psychosis. Other factors might exclude you such as unstable heart conditions, uncontrolled high blood pressure, or problems with bleeding.
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?
- Has a specialist doctor diagnosed you with Parkinson's disease?
- Are your Parkinson's symptoms (like uncontrolled movements or 'on-off' periods) not well-controlled by your current medicines?
- Have you been on a steady dose of your Parkinson's medications for at least the last month?
- Do you have any other brain conditions (like Alzheimer's) or severe memory problems?
- Do you have any unstable heart problems or bleeding disorders?
What does participation involve?
If you decide to take part, you'll be assigned randomly to either receive the active ExAblate Pallidotomy treatment or a 'sham' treatment. The sham treatment feels similar to the real one but doesn't deliver the active sound waves, so we can fairly compare the effects. You won't know which group you're in, and neither will your doctors on the study initially. The procedure itself involves lying in an MRI scanner while the focused ultrasound is delivered. You'll need to be able to talk during the procedure to describe any sensations.
Throughout the study, you'll have several visits to the clinic for assessments. These will include check-ups, neurological exams, and possibly some questionnaires to see how your symptoms are changing and how you're feeling. You'll continue taking your regular Parkinson's medications, but the doses should stay stable unless your study doctor advises otherwise. The total duration of the study visits and follow-up will be 12 months after your treatment.
Potential risks and benefits
Locations (20)
- Stanford University Medical CenterVerified postcodeStanford, United States
- Palm Beach Neuroscience Institute/Sperling Medical GroupVerified postcodeBoynton Beach, United States
- University of Maryland Medical SystemVerified postcodeBaltimore, United States
- Brigham and Women's HospitalVerified postcodeBoston, United States
- Mayo ClinicVerified postcodeRochester, United States
- New York University Health LangoneVerified postcodeNew York, United States
- Weill Cornell MedicineVerified postcodeNew York, United States
- The Ohio State Wexner Medical CenterVerified postcodeColumbus, United States
- Pennsylvania Hospital Department of NeurosurgeryVerified postcodePhiladelphia, United States
- University of Virginia Health SystemVerified postcodeCharlottesville, United States
- Swedish Medical CenterVerified postcodeSeattle, United States
- Toronto Western HospitalVerified postcodeToronto, Canada
Common questions
What is 'dyskinesia'?
Dyskinesia refers to involuntary, jerky, or writhing movements that some people with Parkinson's disease experience, often as a side effect of their medication.
What are 'motor fluctuations'?
Motor fluctuations mean having unpredictable 'on' periods (when your medication works and you move well) and 'off' periods (when your medication isn't working, and you become stiff or slow).
Is this a surgery?
No, ExAblate Pallidotomy uses focused sound waves directed from outside your head, so it doesn't involve cutting or making holes in the skull like traditional surgery.
Will I know if I get the real treatment or the 'sham' treatment?
No, for the study to be fair, you won't know initially whether you received the active treatment or a sham treatment that mimics the procedure without the active sound waves. Your doctors also won't know at first.
How long will I be involved in the study?
If you join, you'll be part of the study for 12 months, including the treatment day and follow-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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