The Focused Ultrasound Foundation is delighted to announce that the first two patients have been treated as part of the Parkinson's study at the University of Virginia. This is a double-blinded study in which patients are being randomly assigned to treatment or sham treatment groups. Because of this, no one will know until "unblinding" occurs in three-months whether or not these patients received an actual focused ultrasound treatment. At this point, we can report that both patients have returned home and are doing well.
We congratulate the study's principal investigator, Dr. Jeff Elias, and his colleagues at the University of Virginia for achieving this important new milestone for the field of focused ultrasound. During the months ahead, the UVA team will continue its pioneering efforts by treating another 28 patients with tremor dominant Parkinson's disease.
The Foundation is helping to fund this clinical trial as part of our strategy to develop noninvasive treatments for Parkinson's disease. We will be closely following the study's progress and providing updates as appropriate to all of you. To learn more about the study, please take a few minutes to read the following press release issued by the Foundation today.
Thank you for your interest, involvement and support. Together, we are accelerating the development and adoption of focused ultrasound therapies.
Neal F. Kassell, MD
Chairman, Focused Ultrasound Foundation
First Treatments Completed for Parkinson's Disease Study Sponsored by the Focused Ultrasound Foundation
CHARLOTTESVILLE, VA (October 23, 2012) - The Focused Ultrasound Foundation today announced a new clinical trial investigating the use of focused ultrasound technology in treating patients with tremor-dominant Parkinson's disease. Funded in part by the Foundation, the study has treated its first two patients at the University of Virginia to evaluate the noninvasive technology's safety and effectiveness in alleviating medication-resistant Parkinsonian tremors.
The trial, led by principal investigator W. Jeffrey Elias, M.D., a University of Virginia neurosurgeon, is an FDA-approved double-blinded protocol study under which 30 patients are being randomly assigned to either treatment or control groups and followed for one year. The subjects are undergoing an investigational procedure that targets a small area deep within the brain using focused sound waves guided by a magnetic resonance scanner. The noninvasive process uses no scalp incisions, electrodes or general anesthesia, allowing patients to remain awake and communicative; it has the potential to be a significant improvement over the current standard of care, which requires surgical implantation of a pacemaker in the brain.
"This study is the next step in the Foundation's roadmap for developing a noninvasive treatment for patients with Parkinson's disease," said Focused Ultrasound Foundation Chairman Neal F. Kassell, M.D. "An effective therapy that works without incisions could transform the treatment of this debilitating condition. Supporting this research is consistent with our objective of getting focused ultrasound into the hands of clinicians who can implement the technology to save and improve the lives of patients around the world."
The new Parkinson's study builds on a recently completed pilot clinical trial. Also performed by Dr. Elias and funded by the Focused Ultrasound Foundation, the study investigated focused ultrasound's use in treating essential tremor. The procedure resulted in tremor reduction for all 15 patients, and further clinical studies are planned.
"It is important for the Commonwealth of Virginia to support innovative research within our borders, and the focused ultrasound studies are an excellent example of how advanced technology can improve healthcare," said William Howell, the Speaker of the Virginia House of Delegates, who helped secure funding for the Parkinson's trial and the Focused Ultrasound Center at the University of Virginia. "We are proud of the role Virginia is playing in the advancement of this high-potential technology."
"The essential tremor trial was our first experience with MR-guided focused ultrasound, and we were very encouraged by the results," said Dr. Elias. "We're eager to extend our investigation and evaluate the technology's use in alleviating symptoms of Parkinson's disease. A treatment without incisions could offer new options and new hope to patients worldwide."
The Parkinson's clinical trial was made possible by an innovative public/private partnership involving the Focused Ultrasound Foundation, the Commonwealth of Virginia, InSightec, maker of the ExAblate Neuro ultrasound device being used in the study, and the donors who have generously supported this research, including Diane and David Heller, Molly and Robert Hardie, the Prince Charitable Trusts and others.
For more information on this clinical trial, please visit: http://www.healthsystem.virginia.edu/pub/ct/ct16203.