InSightec has completed enrollment in the pivotal study of their ExAblate Neuro system for the treatment of essential tremor. Physicians at eight sites worldwide have now treated 76 patients in the trial. The first randomized, controlled trial of unilateral MR-guided focused ultrasound thalamotomy with InSightec’s system began in August 2013 and completed enrollment in September 2014. Results will be submitted to the US Food and Drug Administration (FDA) for regulatory approval of the device. The pivotal study was designed based on the clinical outcome of the initial 15-patient pilot study that was conducted from 2011 to 2012 and published in an August 2013 issue of the New England Journal of Medicine.
Patients with severe, medication-refractory essential tremor were enrolled after being assessed for tremor severity and disability and then randomized in a one-to-three fashion to receive either sham (pretend) procedure or the focused ultrasound treatment. Participating patients are now being followed for one year.
Treatment safety and efficacy are the study’s primary endpoints, with secondary endpoints including durability at 12 months, quality of life, functional improvement, and comparison between the sham and treatment groups. During the follow-up period, an independent, blinded corelab group of neurologists specializing in the management of essential tremor rate the clinical outcomes from videotaped assessments, and the patients will complete disease-specific quality of life questionnaires. Final results are expected to be submitted to the FDA by the end of 2015.
“We all know someone with essential tremor; it’s a common problem. Hopefully this study will lead to a treatment that might be applicable to many patients around the world.”
– Jeff Elias, MD, associate professor of neurological surgery at the University of Virginia and principal investigator of the study