Patients with Parkinson’s disease achieved a big improvement of their tremors, mobility, and other physical symptoms after having a minimally invasive procedure involving focused ultrasound, in keeping with a latest study today published within the Recent England Journal of Medicine.
The clinical trial was led by researchers on the University of Maryland School of Medicine (UMSOM) and involved 94 Parkinson’s disease patients who were randomly assigned to undergo focused ultrasound to ablate a targeted region on one side of the brain or to have a sham procedure. Nearly 70 percent of patients within the treatment group were considered successful responders to treatment after three months of follow-up, in comparison with 32 percent within the control group who had an inactive procedure without focused ultrasound.
Two-thirds of those that responded initially to the focused ultrasound treatment continued to have a successful response from the treatment a yr later.
Patients were treated on the University of Maryland Medical Center (UMMC), the educational flagship hospital for the University of Maryland Medical System, and 15 other sites in North America, Asia, and Europe.
These results are very promising and offer Parkinson’s disease patients a latest type of therapy to administer their symptoms. There isn’t a incision involved, which implies no risk of a serious infection or brain bleeding.”
Howard Eisenberg, MD, study corresponding writer the Raymond K. Thompson Professor of Neurosurgery at UMSOM and a neurosurgeon at UMMC
About a million Americans have Parkinson’s disease, a neurodegenerative disorder that affects brain cells or neurons in a particular area of the brain that produce the brain chemical dopamine. Symptoms include shaking, stiffness, and difficulty with balance and coordination. Other treatments for Parkinson’s include medications and deep brain stimulation (DBS) from surgically implanted electrodes. The medications could cause involuntary, erratic movements called dyskinesia as doses are increased to regulate symptoms. Normally offered when medications fail, DBS involves brain surgery to insert the electrodes through two small openings within the skull. The procedure carries a small risk of great negative effects including brain hemorrhage and infection.
“Our study will help doctors and patients make an informed decision when considering this latest treatment modality to assist higher manage symptoms,” said study co-author Paul Fishman, MD, PhD, Professor of Neurology at UMSOM and a neurologist at UMMC. “However it’s essential for patients to appreciate that not one of the treatments currently available will cure Parkinson’s disease.”
Focused ultrasound is an incisionless procedure, performed without the necessity for anesthesia or an in-patient stay within the hospital. Patients, who remain fully alert, lie in a magnetic resonance imaging (MRI) scanner, wearing a transducer helmet. Ultrasonic energy is targeted through the skull to the globus pallidus, a structure deep within the brain that helps control regular voluntary movement. MRI images provide doctors with a real-time temperature map of the realm being treated, to exactly pinpoint the goal and to use a high enough temperature to ablate it. In the course of the procedure, the patient is awake and providing feedback, which allows doctors to watch the immediate effects of the tissue ablation and make adjustments as needed.
The device, called Exablate Neuro, was approved over a yr ago by the US Food and Drug Administration (FDA) to treat advanced Parkinson’s disease on one side of the brain. The FDA approval was based on findings from the UMSOM clinical trial published today. The procedure is now widely available on the University of Maryland Medical Center (UMMC). Nevertheless, it just isn’t yet covered by insurance, including Medicare, so patients currently have to pay out of pocket for the procedure.
“Focused ultrasound is barely approved by the FDA to treat one side of the brain in Parkinson’s disease patients, so it could be more appropriate at the moment for patients with symptoms predominantly on one side,” said study co-author Vibhor Krishna, MD, a professor of neurosurgery on 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 administer the condition caused her to have uncontrollable shaking. Her symptoms were so severe, she was depending on a walker and unable to take her daughter to the playground. Last June, she opted to have focused ultrasound at UMMC after learning in regards to the FDA approval.
“Focused ultrasound was really transformative. So a lot of my superb motor skills have returned. I’m putting on eyeliner again and taking showers again without falling,” Carlson said. “This truthfully looks like among the best years of my life. I just feel so fortunate. I hope more people can profit from this procedure.”
Patients enrolled within the trial — with moderate Parkinson’s who weren’t responding well to medications — were treated with one session of focused ultrasound on the side of their brain that controlled the side of their body where symptoms were more severe. The study was designed as a crossover trial, where 25 patients within the control group were offered the lively treatment three months after their sham procedure; 20 out of 25 opted to have the focused-ultrasound treatment and experienced similar advantages because the initial treatment group.
Those within the treatment group had a right away improvement of at the very least three points on an ordinary assessment — measuring tremors, walking abilities, and rigidity within the legs and arms — in comparison with an 0.3 point improvement within the control group. In addition they experienced relief from negative effects from Parkinson’s medications. They were assessed again at three months and at 12 months. Patients will proceed to be followed for five years to judge how long the treatment lasts and progression of the disease.
Opposed events from the procedure included headache, dizziness, and nausea that resolved inside a day or two of treatment. Some patients experienced mild negative effects from the focused ultrasound treatment, including slurred speech, walking issues, and lack of taste. These often resolved inside the first few weeks.
Dr. Eisenberg and his colleagues are currently conducting a clinical trial to check the Exablate Neuro device on either side of the brain, delivering focused ultrasound treatments in two sessions, six months apart. “Up to now, we have had promising results,” Dr. Eisenberg said.
The study was funded by Insightec, manufacturer of Exablate Neuro.
“We’re on the sting of the frontier with focused ultrasound, as ongoing research evaluates the procedure in numerous brain areas affected by Parkinson’s, resembling the subthalamic nucleus, which controls movement regulation,” said UMSOM Dean, Mark T. Gladwin, MD, who can be Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor. “Researchers are also studying how focused ultrasound could possibly be used to temporarily open the blood-brain barrier to assist experimental Parkinson’s treatments, like immunotherapy, get into the brain more easily.”
“As home to certainly one of the highest movement disorder centers within the country, and certainly one of only a number of medical centers that supply focused ultrasound for Parkinson’s, we see firsthand the technology’s impact on people’s lives. Congratulations to the researchers-;and the trial participants-;for exemplifying the innovation and discovery that may make focused ultrasound available to more people within the years to come back,” said Bert W. O’Malley, MD, President and CEO of UMMC.
Source:
University of Maryland School of Medicine
Journal reference:
Krishna, V., et al. (2023) Trial of globus pallidus focused ultrasound ablation in Parkinson’s disease. Recent England Journal of Medicine. doi.org/10.1056/NEJMoa2202721.