A global multicenter pivotal trial using focused ultrasound to address the major motor symptoms of Parkinson’s disease is under way.
About the Trial
Stanford University Medical Center
Contact: Vyvian Ngo
University of Maryland Medical Center
Contact: Charlene Aldrich
Weill Cornell Medicine
New York, New York
Contact: Andrea Zanello
The Ohio State University Wexner Medical Center
Contact: Erin Woodburn
Contact: Marie Kerr
University of Virginia Health System
Contact: Matthew Patterson
Severance Hospital, Yonsei University Health System
Contact: Seohee Park
Contact: Huh Nayoung
St. Mary's Hospital
London, United Kingdom
Contact: Lesley Honeyfield
+44 (0) 20 331 10327
This clinical trial is evaluating the safety and efficacy of using INSIGHTEC’s Exablate Neuro device in more than 100 patients with advanced and medication-refractory Parkinson’s disease.
This trial is a randomized, double-blind study, meaning that patients are randomly selected to receive sham - or fake - treatments to lessen the chances of a placebo effect altering outcomes. During treatment and afterwards, it remains unknown whether enrolled patients receive the treatment or a sham procedure for three months, but all patients in the sham arm will have the option to cross over and receive the therapy after three months.
At this time, focused ultrasound is only being assessed to treat one side of the brain, so it will affect tremor or dyskinesia on one side of the body.
Patients in the trial will be followed for one year after focused ultrasound therapy to determine its overall effectiveness and durability.
Patients are currently being enrolled at six medical centers in the United States, one in Korea, and on in the United Kingdom.
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Purpose of The Trial
This pivotal trial is a step toward regulatory approval by the US Food and Drug Administration (FDA) and insurance reimbursement for the widespread use of focused ultrasound as a nonsurgical treatment option to address the symptoms of this common neurological condition. The results of the trial will be considered among the body of knowledge on using focused ultrasound to treat the symptoms of Parkinson's disease when/if Insightec applies for FDA approval.
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Focused Ultrasound for Parkinson’s
Focused ultrasound is an early-stage, non-invasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with Parkinson’s disease. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue. Much like using a magnifying glass to focus the sun's rays and burn a hole in a leaf, where the beams converge, the ultrasound energy can heat and destroy tissue noninvasively.
At this time, focused ultrasound is being researched to achieve symptomatic relief in Parkinson's patients by making thermal lesions deep in the brain to interrupt circuits involved with tremor and dyskinesia. Focused ultrasound is not yet being researched clinically to treat the underlying Parkinson's disease.
Afflicting approximately one million people in the US, Parkinson’s disease 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 noninvasive alternative to surgery with a lower risk of complications and lower cost.
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Previous Clinical Research
This trial follows a pilot trial of 31 Parkinson’s disease patients, treated at six sites in the US and Canada. That study was funded by the Focused Ultrasound Foundation and the Michael J. Fox Foundation for Parkinson’s Research, and the results are awaiting publication.
Another pilot trial studied focused ultrasound’s role in treating patients with tremor-dominant Parkinson’s disease, and the results of that study were published in JAMA Neurology in November 2017.
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Learn More or Enroll
Patients are asked to contact a participating site nearest them to learn more about the trial and the enrollment process.
Kimberly, Steve and Ron all took part in the pilot trial of focused ultrasound to relieve the dyskinesia symptoms associated with Parkinson's disease. They have shared their stories in hopes of helping spread awareness of this novel therapy.
See the trial listing on ClinicalTrials.gov >
About the trial's sponsor, INSIGHTEC >
About focused ultrasound >
About focused ultrasound for Parkinson's disease >
Blog: Is a Parkison's disease clinical trial right for me? >