A pilot clinical trial at the University of Virginia has investigated the use of MR-guided focused ultrasound as a treatment for essential tremor.
For some older adults, the shaking that accompanies essential tremor (ET) can leave such patients helpless to perform many activities of daily living. But a new noninvasive procedure may provide them with hope—and relief from their symptoms.
Often misdiagnosed as Parkinson’s disease, Benign Essential Tremor affects roughly 10 million Americans, according to the International Essential Tremor Foundation. This neurological disorder is characterized by shaking of the hands, head, and voice and sometimes the legs and trunk.
While many cases of ET are mild, according to Neal Kassell, MD, chairman of the Focused Ultrasound Surgery Foundation, some patients suffer severely enough with the condition that they become disabled by the shaking. Fortunately, many people with ET require no treatment for their symptoms, and medication therapy, if needed, can help a good percentage of patients experience symptom control, Kassell says.
But for those with severe ET, invasive surgery may be their only option for symptom relief. One surgical procedure, radio-frequency thalamotomy, involves creating lesions deep in the brain to eliminate abnormal nerve cells, “which is traditionally done by making an incision and drilling into the skull and inserting an electrode, heating up the tip, and killing the cells,” Kassell says. Another option is deep brain stimulation, which involves implanting an electrode in the thalamus to help with controlling the tremors.
“The problem is these procedures are invasive, and many of these patients [those with severe ET] don’t want to have invasive procedures or can’t undergo them because of age or other medical conditions,” Kassell explains.
The good news for these ET patients is that a new procedure, MR-guided focused ultrasound, could provide a noninvasive means of relieving their Benign Essential Tremor Symptoms.
After receiving funding from the Focused Ultrasound Surgery Foundation and approval from the FDA, a pilot clinical trial at the University of Virginia (UVA) investigated the use of MR-guided focused ultrasound as a Treatment for Benign Essential Tremor. Led by W. Jeffrey Elias, MD, a neurosurgeon and director of stereotactic and functional neurosurgery at UVA, the study treated 15 patients between February and December 2011. Thanks to promising results, the FDA has approved the treatment of 15 additional patients under the same clinical trial protocol.
Additionally, a parallel study involving six patients is being conducted at the University of Toronto, also with funding from the Focused Ultrasound Surgery Foundation.
According to Elias, the patient group treated during the first phase of the trial was a “relatively pure population,” meaning the subjects didn’t have Parkinson’s-like features or other conditions along with ET. “These people were very severely disabled with tremor, and all had difficulty with things such as feeding themselves, getting dressed, and writing,” Elias says. “Some patients are afraid to undergo [an invasive] surgical procedure and many of them are just sitting at home living with their disability. They don’t die from tremor, but it’s extremely debilitating.”
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