A study offers the most in-depth assessment yet of the safety and effectiveness of a high-tech alternative to brain surgery to treat the uncontrollable shaking caused by the most common movement disorder.
The paper outlines the results of an international clinical trial, led by Jeff Elias, MD, of the UVA Health System, that evaluated the scalpel-free approach called focused ultrasound for the treatment of essential tremor (ET), a condition that afflicts an estimated 10 million Americans. Not only did the researchers determine that the procedure was safe and effective, they found that it offered a lasting benefit, reducing shaking for trial participants throughout the 12-month study period.
‘This study represents a major advance for neurosurgery, treatment of brain disease and specifically the treatment of ET,’ Elias said. ‘For the first time in a randomized controlled trial, we have shown that ultrasound can be precisely delivered through the intact human skull to treat a difficult neurological disease.’
The multi-site clinical trial included 76 participants with moderate to severe essential tremor, a condition that oft en robs people of their ability to write, feed themselves and carry out their normal daily activities. The trial participants all had tried existing medications, without success. The mean age was 71, and most had suffered with their tremor for many years.
Seventy-five percent of participants received the experimental treatment using focused ultrasound guided by magnetic resonance imaging. The remaining 25 percent underwent a sham procedure, to act as the control group. (They were later given the opportunity to undergo the real procedure.)
Participants who received the treatment showed dramatic improvement, with the beneficial effects continuing throughout the study period. The researchers employed a 32-point scale to assess tremor severity, and they found that mean tremor scores improved by 47 percent at three months and 40 percent at 12 months. Participants reported major improvements in their quality of life. People who couldn’t feed themselves soup or cereal could again do so.
Participants who received the sham procedure, on the other hand, showed no significant improvements.
‘The degree of tremor control was very good overall in the study, but the most important aspects were the significant gains in disabilities and quality of life – that’s what patients really care about,’ Elias said.
The most commonly reported side effects were gait disturbances and numbness in the hand or face; in most instances, these side effects were temporary but some were permanent.
Based on the clinical trial led by Elias, the federal Food and Drug Administration has approved the focused ultrasound device for the treatment of essential tremor.
University of Virginia Health System http://tinyurl.com/z4pv5ss