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Study shows MR-guided focused ultrasound decreases essential tremors by almost half

by Christina Hwang, Contributing Reporter | August 25, 2016
Medical Devices MRI Risk Management Ultrasound
Credit: New England Journal of Medicine
The most common movement disorder, essential tremor (ET), can be effectively treated with the use of MR-guided focused ultrasound, according to a new study in the New England Journal of Medicine.

Researchers at the University of Maryland School of Medicine, alongside an international group of investigators representing eight facilities, used InSightec's ExAblate Neuro system to illustrate a 47 percent improvement among patients with essential tremors receiving the treatment.

It was this research that ultimately led to the FDA approval of the system for treating ET in July, according to a statement.

ET affects an estimated 10 million people in the U.S. alone. MR-guided focused ultrasound destroys the brain tissue responsible for the tremors (a small area called the thalamus) in patients for whom medication has not been effective.

The following video highlights essential tremor and how focused ultrasound thalamotomy may improve the quality of life for individuals with essential tremor.



“This study was conducted in the most rigorous scientific fashion as a randomized controlled trial,” principal investigator and lead author Dr. W. Jeffrey Elias, director of stereotactic and functional neurosurgery at the University of Virginia, told HCB News.

In the randomized, double-blind study, 56 patients received the ExAblate treatment and 20 patients received a pseudo procedure, which was similar to the ExAblate procedure but without ultrasound. The entire procedure lasted two-to-four hours and the patients remained awake.

“Patients were videotaped before and after the treatment, and the videos were rated by an expert group of neurologists (the Tremor Research Group) who were independent of the trial,” said Elias. In addition, the patients were asked to draw spirals on a piece of paper before and after treatment.

The researchers combined the Clinical Rating Scale for Tremor (CRST) Part-A and Part-B, an eight-element measure of tremor and hand function, to measure the patients’ results.

For the group who received actual treatment, the study illustrated that a baseline score of 18.1 was reduced to 9.6 at three months — a 47 percent reduction in symptoms — and the group who did not receive treatment remained unchanged.

At the one year follow-up, the ExAblate group showed a 63.4 percent decrease in tremors and their total disability score improved by 68 percent. Also, their quality of life improved by 51 percent.

“Now patients have more options for treatment, and they especially have a choice for a less invasive surgical option if they become medically refractory,” Elias said.

Along with FDA approval, the ExAblate Neuro has also received Health Canada and Korean approval, as well as CE mark in Europe. Insightec, alongside the Focused Ultrasound Foundation and BIRD Foundation, funded the research.

The sites participating in the study included: University of Virginia, Stanford University Medical Center, University of Maryland, Brigham and Women’s Hospital, Swedish Medical Center, Yonsei University Medical Center (South Korea), Sunnybrook Health Sciences Centre (Canada) and Tokyo Women’s Medical University (Japan).

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