Clinical tests are beginning to test a medical device that uses focused ultrasound together with magnetic resonance imaging to treat deep targets within the brain, without the need for incisions and surgery.

The Exablate Neuro device, developed by Insightec, last week announced the first such procedure for a study requested by the Food and Drug Administration, to test the efficacy of the incisionless surgery to treat advanced Parkinson’s disease in patients who have not responded to medication.

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Using ultrasound as a treatment, guided precisely by MR imaging, holds the promise of treating areas in the brain that are causing tremors, without the risk of physical incisions by surgeons, as well as vastly minimizing the risk that other areas of the brain could be damaged by an invasive procedure.

For Parkinson’s disease patients, the treatment is intended to improve motor function and reduce dyskinesia, one of the debilitating symptoms that these patients exhibit as uncontrolled involuntary movement of the arms or legs—these symptoms often occur as a side effect of medication.

Insightec says the company’s device has already been approved by the FDA to treat patients suffering from essential tremor who have not responded to medication—the expansion of the study to test the response to Parkinson’s disease is the logical next step to see if the device can be used to treat other movement disorders.

"Building on the success of the incisionless focused ultrasound treatment for essential tremor, we are excited to extend its application to the debilitating effects of Parkinson's disease," said Howard Eisenberg, MD, the Raymond K. Thompson, MD Chair in Neurosurgery, and Professor, Department of Neurosurgery, University of Maryland School of Medicine.

Patients are being enrolled for the clinical trial at 10 international medical centers—it follows the pilot trial that was partially funded by the Focused Ultrasound Foundation and the Michael J. Fox Foundation for Parkinson’s Research.

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