Ultrasound Treatment Could Alleviate Parkinson’s Disease Symptoms

According to a new study that was published in the New England Journal of Medicine, Parkinson’s patients who underwent a focused ultrasound treatment saw a significant improvement in their tremors, mobility, and other Parkinson’s disease symptoms.

94 Parkinson’s disease patients participated in the clinical trial, which was directed by scientists at the University of Maryland School of Medicine (UMSOM), and were either given a focused ultrasound technique to ablate a specific area on one side of the brain or a sham surgery. After three months of follow-up, close to 70% of patients in the treatment group were deemed successful treatment responders, as opposed to 32% in the control group who underwent an inert procedure without targeted ultrasound.

A year after receiving the focused ultrasound treatment, two-thirds of those who had an initial positive reaction did so again.

Patients received care at 15 more locations in North America, Asia, and Europe in addition to the University of Maryland Medical Center (UMMC), the academic flagship hospital for the University of Maryland Medical System.

“These results are very promising and offer Parkinson’s disease patients a new form of therapy to manage their symptoms. There is no incision involved, which means no risk of a serious infection or brain bleeding,” said study corresponding author Howard Eisenberg, MD, the Raymond K. Thompson Professor of Neurosurgery at UMSOM and a neurosurgeon at UMMC.

Parkinson’s disease, a neurodegenerative ailment that affects brain cells or neurons in a particular region of the brain that produces the chemical dopamine, affects about one million Americans. Shaking, stiffness, and issues with balance and coordination are among the symptoms. Medication and deep brain stimulation (DBS) using surgically implanted electrodes are further treatments for Parkinson’s. If doses are increased to control symptoms, the drugs can result in dyskinesia, which is uncontrollable, erratic movements. DBS is typically recommended when a medicine is ineffective and requires brain surgery to place the electrodes through two tiny skull incisions. Brain hemorrhage and infection are two significant side effects that could occur as a result of the surgery.

Our study will help doctors and patients make an informed decision when considering this new treatment modality to help better manage symptoms,” said study co-author Paul Fishman, MD, Ph.D., Professor of Neurology at UMSOM and a neurologist at UMMC. “But it’s important for patients to realize that none of the treatments currently available will cure Parkinson’s disease.”

Focused ultrasound is a non-invasive procedure that can be carried out without anesthetic or a hospital stay. Using a transducer helmet, patients lie in an MRI scanner while remaining completely conscious. The globus pallidus, a deep brain region that aids in the regulation of regular voluntary movement, is the target of ultrasonic energy that is directed through the skull. Doctors can precisely locate the target and administer a high enough temperature to ablate it using MRI pictures, which provide them with a real-time temperature map of the area being treated. The patient is awake and giving input during the process, allowing the doctor to watch the tissue ablation’s immediate effects and make any necessary modifications.

Exablate Neuro is a medical device that the U.S. Food and Drug Administration (FDA) approved more than a year ago to treat advanced Parkinson’s disease on one side of the brain. The UMSOM clinical trial’s results, which were released today, served as the basis for the FDA’s clearance. At the University of Maryland Medical Center, the technique is currently readily accessible (UMMC). Patients presently have to pay out of pocket for the operation as insurance, including Medicare, is not yet paying for it.

“Focused ultrasound is only approved by the FDA to treat one side of the brain in Parkinson’s disease patients, so it may be more appropriate at this time for patients with symptoms predominantly on one side,” said study co-author Vibhor Krishna, MD, a professor of neurosurgery at the University of North Carolina, Chapel Hill.

Diagnosed with Parkinson’s disease in 2020, Melanie Carlson, a 41-year-old mother of a toddler, found that the medications she was taking to manage the condition caused her to have uncontrollable shaking. Her Parkinson’s disease symptoms were so severe, she was dependent on a walker and unable to take her daughter to the playground. Last June, she opted to have a focused ultrasound at UMMC after learning about the FDA approval.

“Focused ultrasound was really transformative. So many of my fine motor skills have returned. I’m putting on eyeliner again and taking showers again without falling,” Carlson said. “This honestly feels like one of the best years of my life. I just feel so fortunate. I hope more people can benefit from this procedure.”

Focused ultrasound was applied once to the side of the patient’s body that controlled the side of their symptoms that were more severe in the study participants with moderate Parkinson’s who were not responding well to treatment. Twenty of the 25 patients in the control group who were offered the active treatment three months following their sham procedure chose to have the focused-ultrasound treatment and gained similar benefits to those of the original treatment group. The study was conducted as a crossover trial.

As measured by tremors, walking ability, and rigidity in the legs and arms, those in the treatment group experienced an instant improvement of at least three points, as opposed to a 0.3-point improvement in the control group. In addition, many felt better after taking drugs for Parkinson’s. At three months and twelve months, they underwent further evaluations. Five years of patient monitoring will be used to assess the effectiveness of the treatment and the disease’s development.

Headache, vertigo, and nausea were some of the after-effects of the surgery that vanished a day or two after it was completed. Slurred speech, trouble walking, and taste loss were a few of the mild adverse effects that some patients encountered after receiving focused ultrasound treatment. Typically, they disappeared within the first few weeks.

In a clinical experiment conducted by Dr. Eisenberg and his associates, the Exablate Neuro device is being utilized to give concentrated ultrasound treatments over the course of two sessions spaced six months apart on both sides of the brain. “So far, we’ve had promising results,” Dr. Eisenberg said.

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