A collaborative group of researchers in the US has now published the results from their pilot study showing focused ultrasound to be a safe and feasible treatment for the motor fluctuations and dyskinesias from Parkinson’s disease (PD). Notably, this was the first study where The Michael J. Fox Foundation for Parkinson’s Research participated in funding focused ultrasound treatment.
Teams from five leading focused ultrasound centers used Insightec’s Exablate Neuro system to successfully treat the symptoms in 20 patients with PD. The peer-reviewed article, “MR-guided Focused Ultrasound Pallidotomy for Parkinson’s Disease: Safety and Feasibility,” is now available in the Journal of Neurosurgery. This study builds on the work of Jin Woo Chang, MD, PhD, in Korea.
The results of the clinical trial showed that the dyskinesias of the treated patients improved 59% after treatment, and improvement was sustained over the 12-month follow-up period. Overall, the severity of the motor symptoms also decreased after treatment while adverse events were generally mild and temporary.
The multicenter study was led by the University of Maryland team of neurosurgeon Howard Eisenberg, MD, and neurologist Paul Fishman, MD, PhD.
“Parkinson’s disease patients who experience prominent dyskinesias struggle to carry out daily tasks, and often their quality of life suffers,” said Dr. Fishman. “This feasibility study provided further clinical evidence that focused ultrasound can be used to safely ablate the internal portion of the globus pallidus, which decreased both the frequency and severity of the motor symptoms.”
For this study, the neurosurgery teams used focused ultrasound to perform a unilateral (one-sided) pallidotomy in patients experiencing various types of motor fluctuations or dyskinesia caused by the underlying disease or a side effect caused by the medications used to treat the disease. Levodopa is the “gold standard” medication to treat PD and was approved more than 50 years ago. It is still the only class of medications approved to treat tremors, stiffness, and slow movement caused by PD.
The pilot study was funded by Insightec, the Focused Ultrasound Foundation, and The Michael J. Fox Foundation for Parkinson’s Research. It took place at the following sites:
- Brigham & Women’s Hospital
- Stanford University Medical Center
- The Ohio State Wexner Medical Center
- University of Maryland School of Medicine
- University of Virginia Health Sciences Center
After treating the first 10 patients in Korea in 2018, Dr. Chang said “I hope that these results help facilitate a larger, multicenter trial for patients with Parkinson’s dyskinesia. Due to the limitations of deep brain stimulation and radiofrequency ablation, focused ultrasound may fill the unmet need for these patients.” This early work contributed to the procedure already achieving both approval and reimbursement in some countries in Asia (see Related Stories).
The next phase of research, an international multicenter, randomized, double-blind-controlled pivotal trial, began in April 2018. It has now completed enrollment with a total of 92 patients, and results should begin to be reported at the end of 2021.
“The results of this pilot study are very encouraging, both with regard to safety and efficacy,” said Dr. Eisenberg. “The pivotal study is near completion, and the data from this larger study with more generalizable outcome measures will be available soon. Perhaps most important, a protocol for bilateral treatment has been completed and participating centers are currently being recruited.”
Focused Ultrasound for Parkinson’s Disease Receives National Reimbursement in Japan September 2020
Parkinson’s Dyskinesia Trial Results Published August 2018
Parkinson’s Research Progress Report: Preliminary Results Published, Pivotal Study Approved November 2017
First US Parkinson’s Dyskinesia Patients Treated September 2015
Parkinson’s Patient No Longer Just Spinning Her Wheels September 2015
Parkinson’s Dyskinesia Study Begins February 2014