FDA Approved Staged Bilateral Focused Ultrasound for Parkinson’s Disease: Bringing Hope to Patients
Living with Parkinson’s Disease (PD) can be really tough, especially when tremors interfere with everyday activities. Initially, the Focused Ultrasound procedure was only approved to target one side of the body, offering some relief but often leaving individuals with persistent bilateral symptoms, still experiencing tremors on one side of their body. Now, there’s some exciting news: the FDA has given the green light for staged bilateral Focused Ultrasound for Parkinson’s Disease. This advancement means eligible patients now have a new, non-invasive option to tackle tremors on both sides of their body.
What Is Staged Bilateral Focused Ultrasound?
MRI-guided Focused Ultrasound is a cutting-edge, non-invasive treatment, originally approved for treating tremors on one side for Parkinson’s patients in December of 2018. MRI-guided Focused Ultrasound precisely targets and treats the specific brain areas linked to tremors. But, with the recent FDA approval of staged bilateral Focused Ultrasound, doctors can treat both sides of the body that are impacted by tremors as a result of Parkinson’s Disease. The procedures in the FDA approved staged bilateral Focused Ultrasound for Parkinson’s Disease must be spaced at least six months apart, which allows for healing, helps reduce risks, and allows for careful monitoring of outcomes from the treatment of the first side.
During each treatment session, MRI imaging guides the ultrasound, allowing doctors to zero in on the exact area responsible for the tremors. There’s no need for cuts or implants, and most patients remain awake throughout the procedure. This FDA-approved method provides a safer option for managing tremors for those who haven’t found enough relief through medication.
The Significance: Why FDA Approval Matters
The FDA approved staged bilateral Focused Ultrasound came after clinical trials confirmed its safety and effectiveness in addressing motor symptoms of Parkinson’s Disease. The motor symptoms in particular, were tremors, stiffness, and involuntary movements as a result of Parkinson’s Disease. Previously, Focused Ultrasound was limited to just one side, as treating both sides simultaneously or too close together could heighten the risk of side effects. By staging the procedure, we can minimize risks related to speech, movement, and memory, giving more individuals experiencing tremors as a result of Parkinson’s Disease a shot at better symptom control.
This approval expands treatment options for those with advanced Parkinson’s, allowing healthcare teams to tailor treatment plans that fit each patient’s unique situation. More choices mean brighter prospects for improving the quality of life for those whose tremors disrupt daily activities.
The Importance of Treating Both Sides for Tremors
Parkinson’s tremors usually start on one side of the body but can spread over time and impact the other side of the body as well. If only one side is treated, patients might still find everyday tasks like writing, cooking, or buttoning a shirt quite challenging if they have moderate to severe tremors on the untreated side of their body. Using staged bilateral Focused Ultrasound can enhance independence and improve day-to-day function as both arms or legs become more coordinated.
Even slight improvements in tremors on both sides can significantly impact self-care, hobbies, and social interactions.
How to Talk to Your Neurologist About FDA Approved Staged Bilateral Focused Ultrasound
Starting a chat with your neurologist might seem daunting, but it’s vital to be open and prepared. Here’s how you can approach the subject of FDA approved staged bilateral Focused Ultrasound:
1. Understand Your Symptoms
Keep a record of your tremors, noting when they occur and how they affect your daily life. Share concrete instances with your doctor, like difficulties with eating, writing, or dressing.
2. Review Your Treatment History
Have an overview ready of the treatments you’ve tried so far, including medications and past procedures (like Focused Ultrasound on one side or Deep Brain Stimulation). Let your neurologist know if your symptoms have persisted or worsened despite these attempts.
3. Ask About Your Eligibility
This procedure may not be suitable for everyone. It’s generally for people whose symptoms aren’t sufficiently managed with medication. Inquire about:
- Am I a suitable candidate for staged bilateral Focused Ultrasound?
- What are the potential benefits and risks, considering my medical history?
- What outcomes can I anticipate if I proceed with treatment on the second side?
4. Discuss Safety and the Staging Process
Share any apprehensions you have regarding safety or side effects. Ask your doctor how this staged approach lessens risk and how side effects will be tracked between treatments. It’s also worth discussing recovery times, expected improvements, and follow-up plans.
5. Questions for Second-Side Treatment
If you’ve already had Focused Ultrasound for tremor relief on one side, talk to your neurologist about treating the second side:
- How soon can I have the second side treated after the first procedure?
- Will treating both sides elevate my risk of speech or balance issues?
- What success rates have you observed in patients undergoing bilateral treatment with staged Focused Ultrasound?
- Are there any new eligibility criteria or insurance considerations for the second procedure?
Don’t forget to bring along a family member or caregiver to your appointments for support and to help you remember key points.
Empowering Yourself: Patient Stories and Clinical Insights
Many patients who’ve undergone staged bilateral Focused Ultrasound during the clinical trials, like Jay Stinnett, have shared inspiring stories of regaining their independence and enjoying life once more. Studies have shown noticeable tremor reduction, alongside significant benefits for overall quality of life. Clinical teams stress that careful patient selection and thorough monitoring between sessions are crucial to achieving the best results. Neurologists involved in these therapies are enthusiastic about what increased access to staged bilateral Focused Ultrasound means for the Parkinson’s community.
To Conclude
FDA approved staged bilateral Focused Ultrasound represents a new chapter in treating tremors associated with Parkinson’s Disease. For patients and families grappling with tremors, this advancement provides not only hope but tangible options. Treating both sides of the brain can lead to meaningful improvements in daily life, especially for those who have found traditional treatments inadequate.
Discussing FDA approved staged bilateral Focused Ultrasound with your neurologist is a crucial step in understanding your options and determining whether this procedure could help you manage your tremors more effectively. Ongoing research, patient advocacy, and education are vital in driving advancements and support for everyone impacted by movement disorders.
If you or a loved one are exploring your next steps in managing tremors, don’t hesitate to ask your healthcare team about staged bilateral Focused Ultrasound and share what matters most to you in your daily life. Your voice can help shape the future of Parkinson’s care.
Resources:
(2025, July 8). INSIGHTEC announces FDA approval of staged bilateral focused ultrasound treatment for parkinson’s disease. Insightec. https://insightec.com/news/insightec-announces-fda-approval-of-staged-bilateral-focused-ultrasound-treatment-for-parkinsons-disease/
Kumbroch, D. (2025, July 14). Focused ultrasound to treat parkinson’s symptoms on both sides of the body approved. The Michael J. Fox Foundation for Parkinson’s Research | Parkinson’s Disease. https://www.michaeljfox.org/news/focused-ultrasound-treat-parkinsons-symptoms-both-sides-body-approved