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By Kristin J. Kelley
Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The FDA has approved the first MRI-guided focused ultrasound device (ExAblate Neuro) to treat essential tremor in patients whose condition hasn't been helped by medication. The treatment is contraindicated for those who can't have magnetic resonance imaging because, for example, they have a pacemaker or are allergic to MR contrast agents.
In a clinical trial, patients treated with the device saw a 50% improvement in motor function and tremors at 3 months, compared with their baseline. A 40% improvement was retained at 12 months following treatment. Those in the control group, on the other hand, experienced no improvement.
The device shouldn't be used by pregnant women, by patients taking anticoagulants, or by those with any of the following: advanced kidney disease, history of abnormal bleeding or coagulopathy, severe hypertension, substance abuse issues, or history of stroke. Adverse treatment events include ataxia, gait disturbance, headache, and numbness and tingling of the fingers.
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LINK(S):
FDA news release (Free)
Background: Physician's First Watch coverage of FDA approval of deep brain stimulation for essential tremor (Free)