Ms. Ratledge,
Dr. Elias and the Neurosurgery Department of UVA sincerely thank you for your interest in our functional neurosurgery Focused Ultrasound clinical trials. This procedure is still in the early stage of research, so is not available as a standard therapy. There are no other sites right now in the United States doing these clinical trials. As of today, we are awaiting approval for our next trials in essential tremor and Parkinson’s disease. We expect that it be a few more months before we are enrolling patients in these trials.
The procedure does have a lot in common with the palidotomy you mentioned. The main differences being the means of making the lesion (non-invasive focused ultrasound) and the target. Dr. Elias will use an alternate deep brain target for these upcoming trials: the VIM nucleus of the thalamus.
Please review our responses to the most frequently asked questions, as well as a number of links to additional resources and websites.
I am a patient with essential tremor, Parkinson’s, or other movement disorder. How can I be considered for a UVA clinical trial involving Focused Ultrasound?
As trials open, we work through our database of interested patients to identify potential candidates. You can enter yourself into this database through this website: uvahealth.com/clinical-tria.... Please have your basic medical information (including diagnosis and medications) available when you enter the database. Also, please be aware that we are at an early phase of our research and can only treat a small number of patients as part of these trials. We hope that in the near future larger trials will be conducted involving more sites, and that ultimately, the device will be approved for these and other neurosurgical applications.
The NIH lists the essential tremor trial as recruiting, but you say the trial is not currently open? Why is this?
We have filled the initial 15 slots in our trial, but we are currently working with the FDA to add more slots to this same trial. If approved, we will treat another 15 patients in 2012.
As a tremor patient, what other options are available to me?
Please see our website for functional neurosurgery options available at UVA (uvahealth.com/services/neur.... Also, the International Essential Tremor Foundation (essentialtremor.org/) is an excellent resource for patients with this condition.
How can I find out which focused ultrasound clinical trials are currently open in the United States , and where the trials are being conducted?
Clinical trials that are open to recruitment are listed by the NIH, and can be found at clinicaltrials.gov/. Use the search field and enter “focused ultrasound” as well as the indication you are interested in.
Where can I find out more about Focused Ultrasound Surgery?
The Focused Ultrasound Surgery Foundation (fusfoundation.org) is an excellent educational and informational resource. Private donations to the Foundation have provided the financial support for our research to date. Their webpage that is specific to essential tremor treatment is here: fusfoundation.org/Essential.... Insightec is our regulatory sponsor and the manufacturer of the device we use. Visit their website for more information about this technology: insightec.com.
How can I receive updates about Focused Ultrasound Surgery?
You can subscribe to a newsletter that is sent out monthly by the Focused Ultrasound Surgery Foundation at this link: fusfoundation.org/Newslette....
Sincerely,
Johanna Loomba
Neurosurgery Clinical Trials Office
University of Virginia Health System