For which indications has the FDA approved the use of focused ultrasound in the United States?
As of April 2020, focused ultrasound is approved for the treatment of:
- Essential tremor
- Tremor-dominant Parkinson’s disease
- Ablation of prostate tissue
- Uterine fibroids, and
- Pain from bone metastatic lesions.
How can I find out the approved indications worldwide?
Each year, the Foundation sends out a survey and produces a State of the Field report. The State of the Field is a comprehensive look at focused ultrasound worldwide, and it includes a listing of international approvals for focused ultrasound. (For the 2019 report, that section begins on page 34.)
How do I find a physician who can treat me for essential tremor?
There are two ways to locate this information. The only FDA-approved treatment for essential tremor is with a device manufactured by Insightec. Insightec maintains a current list of treatment centers in the US and Latin America on their website. You can access a list of treatment sites in the rest of the world at the upper right hand side of the page.
The other way is to visit our website. The Foundation conducts a survey of treatment sites and updates it annually. You can visit our Treatment Sites page and use the drop-down menus to refine your results by location.
Note about the survey: Our survey is intended to capture information about focused ultrasound procedures from the medical professionals who are providing care. We strive to capture as many responses as we can, but please understand that information collected in a survey is dependent on the response rate. We share this information as a service to the focused ultrasound community. To our knowledge, it is the best representation of this data that is available.
How can I find a physician to treat me for Parkinson’s disease?
With Parkinson’s disease, there may be movement disorders that can either originate from the Parkinson’s itself or from the medications taken to treat the disease. Focused ultrasound treatment can help alleviate these movement disorders. Focused ultrasound does not, however, treat the underlying cause of Parkinson’s disease.
For the subset of patients with tremor-dominant Parkinson’s disease, focused ultrasound treatment is the same as that used to treat essential tremor. Following the FDA approval for essential tremor in July of 2016, the manufacturer went back to the FDA and asked them to approve the treatment for tremor-dominant Parkinson’s. The FDA approved focused ultrasound for tremor-dominant Parkinson’s in December of 2018. This means that the treatment sites for tremor-dominant Parkinson’s are the same as those linked to above in the essential tremor section.
In the US, Medicare approval is slow, so even for essential tremor, some of the Medicare contractors are still not paying for focused ultrasound treatment in some places. For payment under Medicare for tremor-dominant Parkinson’s, we suggest that you contact the treatment site to inquire about coverage. If you are insured by commercial insurance, then you should check with your carrier. Some of the treatment sites have long waiting lists for patients. However, two sites that generally have shorter waits are in Nebraska City, Nebraska, and at the Ohio State University in Columbus, Ohio.
Most patients with Parkinson’s, have dyskinesia (involuntary movements). Treatment for Parkinson’s dyskinesia has not yet been approved by the FDA, but there is a pivotal clinical trial currently under way. By “pivotal,” we mean that this trial is late stage and is likely to be submitted to the FDA for approval upon completion.
You can read about the trial on clinicaltrials.gov. If you interested in participating, or if you have questions, you should select a treatment site from the list near the end and contact them for more information. The cost to be in the trial is typically covered by the treatment sponsor, but we always recommend confirming this with the treatment site. The Parkinson’s dyskinesia study is close to complete enrollment, so if you are interested, you may want to contact the treatment site soon.
How can I find a physician to treat me for prostate cancer?
For prostate cancer, there are three approved manufacturers of devices, and each of these manufacturers offers resources to help locate treating physician.
It may also be helpful to contact local urologists to inquire directly about their ability to provide focused ultrasound treatment, as there are mobile units that rotate between facilities that are not listed in the above links.
How can I find a physician to treat me for uterine fibroids?
Despite FDA approval years ago in the US, insurance companies have not approved payment, so many of the sites that were set up to meet the demand have ceased operations. You can visit the Treatment Sites page on our website and use the drop-down menus to help locate the nearest treatment site to you.
How can I find a physician to treat me for pain from metastatic bone disease?
Again, the best way to locate a site near you is to visit our Treatment Sites page and use the drop-down menus to refine your results by location.
How do I find out if there is a clinical trial for my disease?
There are two ways to find out about clinical trials. The first is to use the worldwide database, clinicaltrials.gov. There are complete instructions on the site, but a good way to start is to insert the name of the disease or condition in the top entry spot, and then enter “focused ultrasound” in the second spot, to limit the responses to only those including focused ultrasound. Then click “search.” Please note: This is supposed to include the World Health Organization information, but there are still regions of the world not included in this database.
The second way is to visit the Diseases and Conditions section of our website and navigate to the correct information. We do our best to keep our Diseases and Conditions pages updated with the latest information on clinical trials. For an example, visit the neurological section, where you can navigate to information pages more than 20 different conditions and find out whether clinical trials are available.
What is the current status for treating Alzheimer’s disease, dementia, or mild cognitive impairment?
We frequently update our website with new and changing information for both Alzheimer’s and dementia, so we recommend going there first. Many of the studies for Alzheimer’s disease are willing to include patients who “probably” have Alzheimer’s disease, or those who have mild cognitive impairment (MCI).
You can also subscribe to our newsletter, which comes out twice monthly and includes all the latest research and industry news. The newsletter includes announcements of new clinical trials and the latest developments in this area.
There are several clinical studies using focused ultrasound to try to help patients with Alzheimer’s or MCI. The basis for this work was animal studies in Canada and Australia demonstrating that when the blood-brain barrier (BBB) is opened, animals showed a decreased concentration of amyloid in their brain. They also performed better on “Alzheimer’s equivalent” testing. This evidence, coupled with the successful, repeated opening of the BBB in a clinical trial in Canada, has led to the opening of the trials for Alzheimer’s. The studies taking place in Canada are only open to Canadian citizens.
Several studies are underway in the US and France. You can see a full listing of the clinical trials for Alzheimer’s on our website. We recommend that you and your medical team read the studies, and if you believe that you may be a good candidate for the study (or if you have questions), then you should select a treatment site and call them for more information. There has been a lot of publicity for some of these studies recently, so it may take some time before they respond to your inquiry.
There have also been some discussions about using focused ultrasound to open the BBB to allow therapeutic agents into the brain that could not otherwise reach the target. These studies are not yet enrolling patients, but if you sign up for our newsletter, you will be informed when enrollment begins.
What is the current status for using focused ultrasound to treat brain tumors?
We recommend that you visit the brain tumors page on our site for current information. And again, if you sign up for our newsletter you will receive the latest news and updates.
Currently, there are clinical trials using focused ultrasound to ablate (or destroy) benign tumors, especially for pediatric patients. For tumors in adults, the emphasis has shifted toward using focused ultrasound to temporarily open the BBB after surgery to allow therapeutic agents to reach the brain. There is also a study using this approach preoperatively, as it may help to more effectively identify the boundary between tumor and normal tissue.
How can I get data on treatment results?
The best way to get treatment results is from the physicians who are performing the treatments and seeing their patients postoperatively. The next best method is to read the published reports that go through the desired and undesired effects that can occur with any treatment. We update our Diseases and Conditions pages with new results frequently, and the publications are listed at the end of each condition section on our site. This is the best place to look for published information.
What is the best way to keep track of future clinical trials and other news on focused ultrasound?
We have a large community that is interested in the latest focused ultrasound news, so we have a dedicated team working to provide up-to-date information, breaking news, and announcements of new clinical trials in our newsletter and via our social media channels (Facebook, LinkedIn, and Twitter).
If I have a specific question that is not addressed here, who can I contact at the Foundation?
We do our best to respond promptly to inquiries, but we also have other obligations, such as conducting meetings and workshops, collecting information, and tracking progress in the field.
Please contact our Chief Medical Officer, Tim Meakem, MD, if you are unable to locate the information you need on our website. Emails are preferred, to alleviate time-zone issues, and we can provide you with a more detailed response.
Tim Meakem, MD, is the chief medical officer of the Focused Ultrasound Foundation.