Enrolment in first MRgFUS essential tremor feasibility trial completed


InSightec announced on 3 January that it has completed enrolment in the world’s first feasibility study evaluating the use of magnetic resonance guided focused ultrasound (MRgFUS) for treatment of essential tremor, using ExAblate Neuro at University of Virginia , Charlottesville, Virginia, USA.  

Fifteen patients underwent a non-invasive ExAblate treatment to evaluate safety and initial effectiveness of this investigational device. Most patients, who suffered for at least 10 years, experienced tremor improvement and no severe adverse events. They are being followed up for three months.

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

“The safety profile of ExAblate Neuro and initial clinical efficacy are extremely encouraging” said Jeff Elias, principal investigator, director of Stereotactic and Functional Neurosurgery and associate professor of Neurological Surgery and Neurology, University of Virginia. Elias presented interim results at the European MRgFUS symposium in Rome and at the Congress of Neurological Surgery in Washington DC.

The trial was a result of a partnership between the University of Virginia, InSightec, and the Focused Ultrasound Surgery Foundation, which organised and funded the study.