Accelerating the development and adoption of focused ultrasound
August 15, 2013
Clinical Study Pipeline
The success of the ET pilot study has enabled research for other transcranial focused ultrasound treatments that could ultimately impact millions of lives:
The next phase of ET clinical research – a multi-center pivotal study – is starting
Trials involving patients with tremor-dominant Parkinson’s disease and Obsessive Compulsive Disorder are now underway
Patient studies for Parkinson’s dyskinesia, epilepsy, metastatic brain tumors and intracerebral hemorrhage will begin soon
Essential Tremor Pilot Study Overview
The feasibility study, which was conducted from February 2011 through December 2012 at the University of Virginia, treated 15 patients with ET. It marked the first time that a unilateral thalamotomy – which is recognized as an effective treatment for ET – was performed with focused ultrasound. The treatment goal was to improve tremor symptoms on one side of the body, particularly in the dominant hand of each patient. Key study findings:
Hand tremor improved by 75 percent.
Substantial improvements in daily disabilities (85 percent) and quality of life as assessed by clinicians and patients.
Outcomes and complications were comparable to surgical procedures, including radiofrequency thalamotomy and deep brain stimulation.
Promising Results on Focused Ultrasound for Essential Tremor Published
One of the world’s most prestigious medical journals, the New England Journal of Medicine, has published the results of the essential tremor (ET) clinical trial funded by the Foundation and conducted at the University of Virginia by neurosurgeon W. Jeffrey Elias, MD. The patients in the study were treated using InSightec’s ExAblate Neuro system.
This extraordinary achievement raises the profile of focused ultrasound within the worldwide medical community and validates its potential to noninvasively treat ET and other neurological disorders.
Based on the study outcomes – all patients experienced reduced tremor and improved quality of life – a larger trial for FDA approval of focused ultrasound to treat ET is beginning. This research has also paved the way for studying other neurological conditions that could ultimately impact countless lives. (See sidebar.)
The Foundation considers the brain to be the vanguard target for focused ultrasound. Given the challenges of accessing the brain and the high cost, complications and limitations of some current approaches, we believe that this technology has the potential to revolutionize the treatment of many brain disorders by:
gaining access deep within the brain without harming healthy tissue
ablating targeted tissue without exposing the brain to the effects of ionizing radiation
enabling the reversible opening of the blood-brain barrier to deliver therapeutic agents directly to diseased areas
This milestone is a testament to the success of two programs supported by the Foundation:
Our Brain Program, an initiative that funded this landmark study and is steadily advancing the use of focused ultrasound to treat a range of brain disorders.
Our Center of Excellence Program, which established the UVA study facility through an innovative public-private partnership with the Commonwealth of Virginia, the University and InSightec.
We congratulate Dr. Elias and his co-authors on the publication of their research. We also are grateful for the pioneering patients who helped make medical history by participating in this study and the generous donors who fund our work.
We look forward to keeping you informed of future progress.
Sincerely, Neal F. Kassell, MD Chairman, Focused Ultrasound Foundation
Focused Ultrasound Foundation | 1230 Cedars Court, Suite F | Charlottesville VA | 22903
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