June 3, 2013

Mr. Dawson,

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. Patients may only receive this treatment as part of a clinical trial. There are no other sites right now in the United States doing these clinical trials.

We conducted a 15 patient trial in 2011 evaluating the ExAblate focused ultrasound device for treatment of essential tremor. We are planning a follow-up essential tremor trial which will be significantly larger than the first, but mid-2013 would be the soonest we would expect that trial to open. It is impossible to predict an exact date at this time.

We are currently accepting tremor-dominant Parkinson’s disease applicants to UVA IRB-HSR#16203, a trial evaluating the ExAblate focused ultrasound device for safety and effectiveness in reducing tremor related to Parkinson’s disease. Patients may apply using the online database described below.
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 our 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.

You can find more information about UVA’s development and use of Focused Ultrasound technology at this website: http://uvahealth.com/services/neuros...sed-ultrasound. 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: https://www.healthsystem.virginia.ed...ltrasoundtrial . Please have your basic medical information (including diagnosis and medications) available when you enter the database. Once you submit your form, you automatically enter the pool of candidates for the trial. You will not receive a reply from our team until you are selected using our approved process and screened as a candidate. At this time, we are only screening for our Parkinson’s trial. Applicants with other diagnosis will stay in the database until an appropriate trial opens, at which time they will be notified.

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 http://www.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 (http://www.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: http://www.fusfoundation.org/Essenti...sential-tremor.

Insightec is our regulatory sponsor and the manufacturer of the device we use. Visit their website for more information about this technology: http://www.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: http://www.fusfoundation.org/Newslet...sletter-signup

Sincerely,
Charles McMillian
Clinical Research Staff
Neurosurgery Clinical Trials Office
University of Virginia Health System