FDA approves scalpel-free brain surgery to treat essential tremor
Staff Writer |
The Food and Drug Administration (FDA) has approved the first focused ultrasound device to treat essential tremor, the most common movement disorder, in patients who do not respond to medication.
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The scalpel-free approach has been pioneered by Jeff Elias at the University of Virginia School of Medicine, who led an international clinical trial that demonstrated the safety and effectiveness of the device.
The technology focuses sound waves inside the brain to create heat, much like a magnifying glass focuses light. That heat can then be used to carefully interrupt circuits of the brain that are responsible for the tremor.
With magnetic resonance imaging, Elias can monitor the location and intensity of the procedure in real-time - an important safety feature when making a precise lesion deep inside the brain. He can actually watch as the tremor reduces.
Elias oversaw an international clinical trial of the device tested in 76 patients with severe tremor who had not responded to medication. Fifty-six participants in the double-blind study received the procedure, while 20 others were in a control group that received a sham procedure.
The results were dramatic: Overall, those treated saw their tremor reduced by half after three months and by 40 percent after a year.
That's comparable to the results of deep-brain stimulation, an invasive surgery that involves placing electrodes inside the brain. Unlike with deep-brain stimulation, patients who receive the focused-ultrasound procedure are treated without incisions or the implantation of neurostimulator devices.
The most common side effects of the procedures were sensory changes like numbness or tingling as well as balance disturbance that tended to be transient. Nineteen of the 20 patients who received the sham procedure during the trial went on to receive the focused-ultrasound procedure.
The FDA approval of the ExAblate focused ultrasound device, manufactured by InSightec Inc., means UVA can make the procedure available to eligible patients. It is important to note, however, that insurance plans will not yet cover the procedure. The cost at UVA has not yet been determined. ■