Summary: Non-surgical focused ultrasound treatments significantly improve movement, tremors and other physical symptoms of Parkinson’s disease, researchers report. Two-thirds of patients who received a focused ultrasound reported improvement in symptoms up to one year after treatment.
Source: University of Maryland
According to a new study published today in the New England Journal of Medicine.
The clinical trial was conducted by researchers at the University of Maryland School of Medicine (UMSOM) and involved 94 patients with Parkinson’s disease who were randomly assigned to undergo a focused ultrasound to remove a region targeted to one side of the brain or to undergo a sham procedure.
Nearly 70% of patients in the treatment group were considered to have successfully responded to treatment after three months of follow-up, compared to 32% in the control group who underwent an inactive procedure without focused ultrasound.
Two-thirds of those who initially responded to focused ultrasound treatment continued to have a positive treatment response one year later.
Patients were treated at the University of Maryland Medical Center (UMMC), the flagship teaching hospital of the University of Maryland Medical System, and at 15 other sites in North America, Asia and Europe.
“These results are very promising and offer patients with Parkinson’s disease a new form of therapy to manage their symptoms. There is no incision involved, which means there is no risk of serious infection or brain hemorrhage,” said study corresponding author Howard Eisenberg, MD. Raymond K. Thompson Professor of Neurosurgery at UMSOM and Neurosurgeon at UMMC.
About one million Americans have Parkinson’s disease, a neurodegenerative disease that affects brain cells or neurons in a specific area of the brain that produce the brain chemical dopamine. Symptoms include tremors, stiffness, and difficulty with balance and coordination.
Other treatments for Parkinson’s disease include medications and deep brain stimulation (DBS) from surgically implanted electrodes. Medications can cause involuntary, erratic movements called dyskinesia when doses are increased to control symptoms.
Usually offered when medication fails, DBS involves brain surgery to insert electrodes through two small openings in the skull. The procedure carries a low risk of serious side effects, including brain hemorrhage and infection.
“Our study will help physicians 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 neurologist at UMMC. . “But it’s important for patients to realize that none of the currently available treatments will cure Parkinson’s disease.”
Focused ultrasound is an incisionless procedure, performed without anesthesia or hospitalization. The patients, who remain fully alert, lie in a magnetic resonance imaging (MRI) scanner, wearing a transducer headset.
Ultrasonic energy is targeted through the skull to the globus pallidus, a structure deep in the brain that helps control regular voluntary movements. MRI images provide physicians with a real-time temperature map of the treated area, to precisely locate the target and apply a high enough temperature to bleed it.
During the procedure, the patient is awake and provides feedback, allowing doctors to monitor the immediate effects of tissue removal and make any necessary adjustments.
The device, called Exablate Neuro, was approved more than a year 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 UMSOM clinical trial results released today. The procedure is now widely available at the University of Maryland Medical Center (UMMC). However, it is not yet covered by insurance, including Medicare, so patients currently have to pay out of pocket for the procedure.
“Focused ultrasound is only FDA-approved to treat one side of the brain in patients with Parkinson’s disease, so it may be more appropriate at this time for patients with symptoms primarily 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, discovered that the medications she was taking to manage the condition were causing her to shake uncontrollably. Her symptoms were so severe that she was dependent on a walker and unable to take her daughter to the playground. Last June, she opted for a focused ultrasound at UMMC after learning about FDA approval.
“The focused ultrasound was really transformative. So many of my fine motor skills came back. I’m putting eyeliner back on and taking showers again without falling off,” Carlson said. one of the best years of my life. I feel so lucky. I hope more people can benefit from this procedure.
Patients enrolled in the trial – with moderate Parkinson’s disease who did not respond well to medication – were treated with a focused ultrasound session on the side of their brain that controlled the side of their body where the symptoms were. the most serious.
The study was designed as a crossover trial, where 25 patients in the control group were offered the active treatment three months after their sham intervention; 20 out of 25 opted for the focused ultrasound treatment and experienced similar benefits as the initial treatment group.
Those in the treatment group had an immediate improvement of at least three points on a standard assessment – measuring tremor, walking ability and leg and arm stiffness – compared with a 0.3 point improvement in the a group of witnesses.
They also experienced relief from the side effects of Parkinson’s disease medications. They were reassessed at three months and at 12 months. Patients will continue to be followed for five years to assess treatment duration and disease progression.
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Adverse events from the procedure included headaches, dizziness and nausea which resolved within a day or two of treatment. Some patients have experienced mild side effects from focused ultrasound treatment, including slurred speech, walking problems, and loss of taste. These usually disappeared within the first few weeks.
Dr. Eisenberg and his colleagues are currently conducting a clinical trial to test the Exablate Neuro device on both sides of the brain, delivering focused ultrasound treatments in two sessions, six months apart.
“So far, we’ve had promising results,” Dr. Eisenberg said.
About this research news on neurotech and Parkinson’s disease
Author: Press office
Source: University of Maryland
Contact: Press Office – University of Maryland
Picture: Image is in public domain
Original research: Access closed.
“Focused ultrasound ablation trial on the globus pallidus in Parkinson’s disease” by Paul Fishman et al. NEJM
Abstract
Focused ultrasound ablation trial of the globus pallidus in Parkinson’s disease
BACKGROUND
Unilateral focused ultrasound ablation of the inner segment of the globus pallidus has reduced motor symptoms of Parkinson’s disease in open-label studies.
METHODS
We randomly assigned, in a 3:1 ratio, patients with Parkinson’s disease and dyskinesias or motor fluctuations and motor impairment in the drug-free state to undergo either focused ultrasound ablation in front of the most symptomatic side of the body, a sham procedure. The primary endpoint was response at 3 months, defined as a decrease of at least 3 points from baseline in the Movement Disorders Society Unified Parkinson’s Disease Rating Scale score. , part III (MDS-UPDRS III), for the treated side in the off-medication state or in the Unified Dyskinesia Rating Scale (UDysRS) score in the on-medication state. Secondary outcomes included changes from baseline to Month 3 in scores of various parts of the MDS-UPDRS. After the blinded phase of 3 months, an open-label phase lasted up to 12 months.
RESULTS
Of 94 patients, 69 were assigned to undergo ultrasound ablation (active treatment) and 25 to undergo the sham procedure (control); 65 patients and 22 patients, respectively, completed the primary outcome assessment. In the active treatment group, 45 patients (69%) had a response compared to 7 (32%) in the control group (difference, 37 percentage points; 95% confidence interval, 15 to 60; P = 0.003 ). Of the patients in the active treatment group who had a response, 19 met the MDS-UPDRS III criterion only, 8 met the UDysRS criterion only, and 18 met both criteria. The results for the secondary endpoints were generally in line with those for the primary endpoint. Of the 39 patients in the active treatment group who had a response at 3 months and were evaluated at 12 months, 30 continued to have a response. Adverse events related to pallidotomy in the active treatment group included dysarthria, gait disturbance, taste loss, visual disturbances, and facial weakness.
CONCLUSION
Unilateral pallidal ultrasound ablation resulted in a higher percentage of patients with improved motor function or reduced dyskinesia than a sham procedure over a 3-month period, but was associated with adverse events. Longer and larger trials are needed to determine the effect and safety of this technique in people with Parkinson’s disease. (Funded by Insightec; ClinicalTrials.gov number, NCT03319485.)