Research published last month in the New England Journal of Medicine demonstrated that a focused ultrasound procedure improved motor function in patients with Parkinson’s disease.
The non-surgical outpatient procedure takes place in an MRI scanner and does not require anesthesia. Exablate® Neuro, technology developed by Insightec, was FDA approved in November 2021 for the treatment of motor symptoms in patients with advanced Parkinson’s disease. It uses a focused ultrasound platform to ablate the globus pallidus, a part of the basal ganglia.
In the trial, led by researchers at the University of Maryland School of Medicine, 94 treatment-refractory patients with Parkinson’s were randomly assigned 3:1 to receive the ablation or a sham procedure. The primary outcome was a ≥3-point reduction in the Movement Disorders Society–Unified Parkinson’s Disease Rating Scale, part III (MDS-UPDRS III) in the off-medication state or in the Unified Dyskinesia Rating Scale (UDysRS) in the on-medication state.
Three months after the procedure, 45 patients (69%) demonstrated a treatment response compared with 7 (32%) in the control group (∆ 37%; 95% CI, 15 to 60; P=0.003). Those in the control group were eligible to enter an open-label phase of the study, which produced results consistent with the randomized phase. Adverse events included headache, nausea, and dizziness. Patient will be followed for five years to evaluate disease progression and long-term efficacy.
“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 author Dr. Howard Eisenberg.
The ultrasound procedure is currently approved to treat one side of the brain in Parkinson’s, but research evaluating Exablate® Neuro in both sides of the brain is underway.