The first patient has been treated as part of a Phase III clinical trial for treatment of medication-refractory essential tremor (ET) using Insightec’s ExAblate Neuro Focused Ultrasound System. ET is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million individuals in the United States.
The ExAblate Neuro system combines focused ultrasound and magnetic-resonance imaging (MRI) to ablate a tiny portion of the brain circuit responsible for the tremor. Over one thousand ultrasound waves are focused simultaneously on a single site in the thalamus for the treatment. Because sound waves can pass through the skull, there’s no need for scalpels or anesthesia. The real-time MR images allow the surgeon to target the sound waves very precisely and also provide continuous guidance and thermal feedback throughout the procedure.
Results of promising pilot studies demonstrating the preliminary safety and effectiveness of MR guided focused ultrasound technology in treating target areas deep inside the brain were recently published in the New England Journal of Medicine and The Lancet Neurology.
In this new study, 72 patients will be enrolled in up to eight centers around the world and randomized to either an ExAblate Neuro or sham (no) treatment. All patients will be assessed at 6 and 12 months, and followed for up to 5 years. The results of this trial are expected to support a submission of the ExAblate Neuro to the FDA for Pre-Market Approval
“Focused ultrasound is an alternative to surgery with the potential for less risk of hemorrhage, infection and brain damage,” said Dr. Neal Kassell, chairman of The Focused Ultrasound Foundation, funder of the pilot studies. “We hope this pivotal trial will demonstrate safety and long-term efficacy, leading to the regulatory approval of this non-invasive technology to help improve quality of life for people suffering from essential tremor.”
The study is being funded through a unique public-philanthropy-industry collaboration between the Focused Ultrasound Foundation, InSightec and The BIRD (US-Israel Binational Industry R&D) Foundation.
