The Food and Drug Administration has approved focused ultrasound as a treatment for a symptom of Parkinson’s disease, opening up the pioneering treatment for widespread use.
Studies at the University of Virginia, which partners with the Charlottesville-based Focused Ultrasound Foundation, laid the groundwork for the approval. People with Parkinson’s disease who suffer from uncontrollable shaking will now have access to focused ultrasound and the possibility of insurance reimbursement.
“We’re just thrilled that finally people with Parkinson’s can have some relief,” said Dr. Jeff Elias, a neurologist at UVa who has led the effort.
Focused ultrasound sends sound waves through a patient’s skull and, guided by magnetic-resonance imaging, concentrates them on a specific spot. Doctors can make precise lesions in the brain without scalpels or incisions.
The approval was based on a clinical trial of 27 patients at UVa and the Swedish Neuroscience Institute in Seattle. People who received focused ultrasound treatment saw significant improvement in hand tremors three months later.
The FDA approved focused ultrasound for essential tremor in 2016. At that time, Elias said, people began signing up for Parkinson’s treatment, as well. Now that the FDA has approved the device for wider use, insurance companies will begin offering reimbursement and Elias can get to work on his patient waitlist.
“We’ve done a lot of research on Parkinson’s, but it’s all been under research protocols,” he said. “Now, for the first time, it’s been approved for a clinical setting.”
In a news release, the Israel-based company INSIGHTEC, which manufactures the device that looks like an old-fashioned hairdryer, praised the step.
“Focused ultrasound has the potential to improve the quality of life of patients living with medication-refractory tremor, whether from essential tremor or Parkinson’s disease,” Dr. Maurice R. Ferré, INSIGHTEC’s CEO and board chairman, said in a news release. “This is an important milestone in expanding focused ultrasound treatment for a growing number of neurological indications.”
Elias cautioned that there’s still no cure for Parkinson’s; focused ultrasound only reduces tremors that previously have not responded to treatment. However, it does have wide-ranging benefits. A 2018 UVa study indicated that focused ultrasound not only treats the direct symptoms but also improves the quality of life, mood and cognitive ability of people with Parkinson’s.
The technology is also in various stages of testing to treat cardiovascular, endocrine, musculoskeletal and other disorders.