FIRST US PATIENT TREATMENTS WITH FOCUSED ULTRASOUND FOR PARKINSON’S DISEASE
INSIGHTEC congratulates the researchers at the University of Maryland and the University of Virginia for performing the first two focused ultrasound treatments in the United States for dyskinesia associated with Parkinson’s disease as part of the company’s FDA study.
These treatments are part of a pilot study of 20 patients assessing the feasibility, safety and preliminary efficacy of MR-guided focused ultrasound pallidotomy for dyskinesia that occurs with Parkinson’s disease. The study will soon include two additional research centers.
Investigators are using magnetic resonance imaging (MRI) to guide ultrasound waves through the intact skin and skull to reach the globus pallidus, a structure deep in the brain. If successful, focused ultrasound could offer an alternative approach for certain patients with Parkinson’s disease who have failed medical therapy or become disabled from medication-induced dyskinesia. Worldwide, to date, seven dyskinesia patients in Korea and one patient in Canada have been treated for dyskinesia now along with hundreds of other patients with Essential Tremor.
The Parkinson’s dyskinesia studies are being conducted using INSIGHTEC’s ExAblate Neuro system. “This is another major achievement in the development of focused ultrasound, which is under investigation to provide less invasive relief to patients suffering from movement disorders. We congratulate the teams in Maryland and Virginia for their pioneering research and support of the technology,” said Eyal Zadicario, Vice President for R&D and Director of INSIGHTEC’s Brain Program.
Funding for the Parkinson’s dyskinesia studies has been provided by the Focused Ultrasound Foundation, The Michael J. Fox Foundation for Parkinson’s Research, and INSIGHTEC, which is also the regulatory sponsor. Eligible patients will include those whose medication has failed to satisfactorily control dyskinesia, who are not candidates for surgery or who choose not to undergo surgery. If the trials are successful, a large study is planned in advance of seeking FDA approval and reimbursement of focused ultrasound to treat dyskinesia in Parkinson’s disease patients.