The device uses focused ultrasound and magnetic resonance imaging (MRI) to destroy a target deep in the brain — the Vim nucleus of the thalamus — through an intact skull. This area has been identified as responsible for causing Parkinson’s tremors. The MRI technology enables physicians to guide treatment planning and deliver thermal feedback in real-time monitoring.
The therapy aims to improve motor function and treat the characteristic involuntary movements of arms and legs, which may occur as a side effect of medication, and impair patients’ quality of life and ability to perform daily activities.
In July 2016, Insightec’s therapy become the first focused ultrasound device approved by the U.S. Food and Drug Administration (FDA) for the treatment of medication-resistant essential tremors with non-invasive thalamus destruction. In October 2017 the FDA granted approval to initiate the trial for these patients.
The trial (NCT03454425) evaluates the safety and effectiveness of the ExAblate System for the treatment of Parkinson’s motor features. It is currently enrolling patients who are 30 or older and have predominant motor disability from one side of the body. Insightec plans to recruit a total of 40 participants and expects to complete the research by December 2020.
“Building on the success of the incisionless focused ultrasound treatment for essential tremor, we are excited to extend its application to the debilitating effects of Parkinson’s,” Howard Eisenberg, MD, the study’s principal investigator and a neurosurgery professor at the University of Maryland School of Medicine, said in a press release.
Eisenberg is recognized as one of the nation’s top neurosurgeons and an expert on traumatic brain injury and the blood brain barrier.
“INSIGHTEC is committed to supporting focused ultrasound research, which is much less invasive than conventional surgery, and has the potential of improving the lives of people living with Parkinson’s,” said Maurice R. Ferré, MD, CEO at Inisightec.
The company recently began a parallel Phase 3 trial (NCT03319485) of its MRI-guided focused ultrasound system for treating motor symptoms in Parkinson’s. It plans to recruit more than 100 patients with advanced idiopathic Parkinson’s not responding to available therapies. Patient enrollment is ongoing at sites in Maryland, New York, Ohio, Pennsylvania, and Virginia. More information is available here.