InSightec receives FDA approval to begin phase I Parkinson’s trial of ExAblate Neuro


InSightec has announced that it has received approval from the US Food and Drug Administration (FDA) to begin a phase I clinical trial evaluating the use of its ExAblate Neuro system for the treatment of patients with tremor dominant Parkinson’s disease. 

Thirty patients who suffer from medication-resistant tremor of Parkinson’s disease will be treated in a randomised control trial and followed-up for one year.

ExAblate Neuro combines high intensity focused ultrasound for deep accurate lesioning of the brain, with continuous real-time MR guidance for visualising brain anatomy, planning and monitoring treatment and outcome. The lesioning is performed through an intact skull with no incisions or ionizing radiation.

The trial will be sponsored in collaboration with the Focused Ultrasound Foundation of Charlottesville, Virginia, USA. The Foundation has established a brain programme to define and help implement a comprehensive R&D roadmap for brain applications with MRgFUS.

Jeff Elias, director of Stereotactic and Functional Neurosurgery and associate professor of Neurological Surgery and Neurology, University of Virginia, Charlottesville, USA is the lead investigator. Elias was recently the principal investigator of a phase I trial evaluating the use of the ExAblate Neuro for the treatment of essential tremor.