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.

About the Focused Ultrasound Foundation

The Focused Ultrasound Foundation is a medical technology research, education and advocacy organization dedicated to improving the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ultrasound. The Foundation is unique in that it supports development of improved treatment for a wide variety of diseases utilizing a platform technology that exerts multiple mechanisms of action.

Positioned at the nexus of the large, diverse group of stakeholders comprising the ultrasound community, the Foundation functions as an independent, trusted and unbiased third-party, aligning organizations into a cohesive ecosystem with a single goal: To make focused ultrasound technology available to patients in the shortest time possible.  The Foundation works to establish a patient centric culture, instill a sense of urgency in all stakeholders, and alleviate barriers to progress.

The Foundation catalyzes collaboration and partnerships, organizes and funds research, spearheads advocacy and patient support initiatives, and sponsors meetings, symposia and workshops to create and disseminate knowledge and increase awareness of focused ultrasound.  Early-stage research funded by the Foundation “de-risks” subsequent investment, thus encouraging other funding sources such as disease specific foundations, the NIH, and industry to become more involved.

The Foundation is on the leading edge of the venture philanthropy and social entrepreneurship movements and is a model of how private philanthropy can work in concert with academia, industry and government to bridge the gap between research and commercialization of a high impact medical technology.

Established in 2006 as a tax exempt organization, the Foundation is based in Charlottesville Virginia and has global activities.

 

About Focused Ultrasound

Focused ultrasound is a revolutionary, noninvasive therapeutic technology with the potential to transform the treatment of many serious medical disorders including tumors of the brain, breast, prostate, liver and other organs, Parkinson's disease, epilepsy, and stroke. With ongoing research, focused ultrasound could address unmet clinical needs and provide treatments which are superior to best current therapy, thereby improving the quality of life and longevity for millions of patients around the world.

This breakthrough technology uses ultrasonic energy guided by magnetic resonance or ultrasound imaging to treat tissue deep in the body without incisions or radiation.  Multiple intersecting beams of ultrasound are directed and concentrated with on a target as small as a grain of rice, much like a magnifying glass can focus multiple beams of light on a single point.  

A variety of profound biological effects result at the focal point where the beams converge; where individual beams pass unfocused through adjacent tissue on the way to their target,they exert no effect or damage.   Integrated magnetic resonance and ultrasound imaging  identifies and targets the tissue to be treated, guides and controls the treatment interactively, in real time, and provides immediate confirmation of the effectiveness of the therapy.  Because focused ultrasound offers many mechanisms of action, treatment of a wide variety of conditions is possible.

Focused ultrasound has the potential to be the ultimate in noninvasive surgery, an alternative or complement for radiation therapy, the means to dissolve blood clots and restore circulation through blocked vessels, and a way to deliver drugs in extremely high concentration to a precise point in the body, thus avoiding systemic toxicity.

Focused ultrasound is performed in an outpatient setting without general anesthesia.  There are no incisions or scars, minimal pain and discomfort, and more rapid recovery.  The technology has the potential to result in fewer complications such as infection or blood clots, avoid the toxic side effects of drugs and radiation therapy, and deliver treatment that is safer and more effective, costs less, and produces an immediate and verifiable effect.

Focused ultrasound is approved in the US and EU and a number of other countries for treatment of uterine fibroids and approved in the EU and other countries for treatment of bone metastases and prostate cancer.  In addition, extensive research is being conducted around the world on a number of clinical applications.