A preliminary clinical trial of a scalpel-free form of brain surgery that uses sound waves to treat essential tremor – a progressive neurological disease that affects millions – has produced positive results that warrant large-scale testing, a University of Virginia School of Medicine researcher announced today.
Jeffrey Elias, MD, unveiled the findings of his groundbreaking focused ultrasound study at the 81st annual meeting of the American Association of Neurological Surgeons in New Orleans. Elias’ noninvasive approach uses focused ultrasound guided by magnetic-resonance imaging to ablate a tiny part of the brain circuit responsible for the shaking that characterizes the disorder.
“These preliminary results have given us great optimism that focused ultrasound may indeed be used to treat a variety of neurologic disorders in the future,” Elias said. “We are very excited to proceed with further clinical trials in essential tremor and other neurological diseases.”
Fifteen volunteers with essential tremor underwent the focused ultrasound procedure as part of UVA’s initial clinical trial. The results include:
A 67 percent reduction , overall, in participants’ hand tremor one year after the procedure. Substantial improvement in participants’ quality of life. Only minimal adverse side effects, mostly mild sensations in the face or hand.
Quality of life was evaluated prior to the procedure, three months after the procedure and then again at a year afterward. Magnetic-resonance imaging was used repeatedly during the first three months to evaluate the effects of the surgery inside the brain. Elias will continue to follow the study participants annually, as he would any patient who undergoes a movement-disorder surgery.
Based on the successful findings of the preliminary trial, the UVA researchers have concluded that further study is warranted to assess fully the safety and long-term effectiveness of focused ultrasound in treating essential tremor. UVA will serve as the lead site for a larger multi-site, international trial scheduled to begin this summer. It is expected to involve eight sites on three continents and treat 72 patients.
Elias is also conducting an initial clinical trial at UVA to test focused ultrasound’s potential to reduce tremor in people with medication-resistant Parkinson’s disease .
All pilot study treatments were performed at the University of Virginia Focused Ultrasound Center, which was made possible by a partnership of UVA, the commonwealth of Virginia, the Focused Ultrasound Foundation and InSightec Ltd., the manufacturer of the focused ultrasound.