Researchers have achieved two milestones in clinical studies testing focused ultrasound to reduce either the tremors or dyskinesia associated with Parkinson’s disease.
Tremor: Preliminary Pilot Study Results Published
Investigators from the University of Virginia (UVA) and Swedish Neuroscience Institute led by UVA’s Jeff Elias, MD, Professor of Neurological Surgery, have published encouraging preliminary results from their Foundation-sponsored, pilot study using the Exablate Neuro focused ultrasound system to treat patients with tremor-dominant Parkinson’s disease. The prestigious JAMA Neurology reported the three-month findings, which suggest a statistically significant level of efficacy for using unilateral focused ultrasound thalamotomy to safely reduce tremor and improve quality of life.
Although a substantial placebo response was also found, the two-center, double-blind, sham-controlled, randomized clinical trial of 27 patients found that the patients’ hand tremors improved 62% at three months following the procedure (versus a 22% improvement in the sham group). All patients will continue to be followed for 12 months, and final results will be analyzed and published at that time. The safety profile of the procedure is also being studied, and some adverse events were noted. The median age of patients in the study is 67.8 years.
Going forward, a large multicenter study will better define the future role of focused ultrasound in managing this aspect of Parkinson’s disease. “Our findings suggest that the patients likely to benefit from this approach are those for whom tremor reduction is enough to improve their quality of life,” said UVA researcher Binit Shah, MD.
Dyskinesia: FDA Approves Pivotal Clinical Trial
Insightec has announced that patients who suffer from Parkinsonian dyskinesia will now have access to a new pivotal clinical trial that will begin in 2018 at the University of Maryland Medical Center under the direction of Dr. Howard Eisenberg, Chair of its Department of Neurosurgery and Professor of Neurosurgery at the University of Maryland School of Medicine.
The study, which was approved by the FDA last month, will use the Exablate Neuro focused ultrasound system to treat dyskinesia symptoms or motor fluctuations. The goal of the randomized, double-blind, sham-controlled clinical trial is to evaluate safety and effectiveness of performing a unilateral focused ultrasound pallidotomy for managing dyskinesia symptoms in patients with advanced and medication-refractory disease. The pivotal clinical trial is a follow-up study to the successful pilot study that was co-funded by the Focused Ultrasound Foundation and the Michael J. Fox Foundation for Parkinson’s Research.
Patients or physicians who are interested in finding out more about the study’s inclusion and exclusion criteria should check ClinicalTrials.gov or contact the University of Maryland Medical System in Baltimore.
Read Insightec’s Press Release on the new dyskinesia clinical trial >
Read coverage of the new dyskinesia clinical trial in Parkinson’s News Today and DOTMed.com.
Read the complete study at ClinicalTrials.gov >
About Parkinson’s Disease
Afflicting millions of people worldwide, including approximately one million in the United States alone with 60,000 additional diagnoses each year, Parkinson’s has no cure, and the major options for treatment of motor symptoms include drug therapy and invasive surgery (e.g., deep brain stimulation or radiofrequency lesioning). For certain patients, focused ultrasound could provide a non-invasive alternative to surgery with a lower risk of complications and lower cost. In the long term, focused ultrasound may have the potential to treat the underlying disease pathology to prevent progression or restore lost function.
Related Foundation Stories – Parkinson’s Tremor and Dyskinesia Timeline
Parkinson’s Dyskinesia Update – All Patients Enrolled July 2017
Parkinson’s Patient Hits the Ground Running after Focused Ultrasound April 2017
Parkinson’s Patient No Longer Just Spinning Her Wheels September 2015
First U.S. Patients Treated with Focused Ultrasound for Parkinson’s Disease September 2015
Argo Mastermind Tony Mendez Announces Battle with Parkinson’s Disease, Support for Focused Ultrasound October 2014
Parkinson’s Dyskinesia Study Begins January 2014
BBC Features Parkinsonian Tremor Treatment October 2013
Focused Ultrasound Foundation Awarded $600,000 Grant from Michael J. Fox Foundation for Parkinson’s Research June 2013
First Treatments Completed for Parkinson’s Disease Study Sponsored by the Focused Ultrasound Foundation October 2012
U.Va. to Test Focused Ultrasound for Treating Parkinson’s Disease October 2012
First Parkinson’s Patients Scheduled for Treatment in Foundation-Funded Study at UVA September 2012
FDA Approves Launch of Parkinson’s Disease Clinical Trial August 2012