Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
ExAblate Pallidotomy for Parkinson's Disease
ExAblate MRgFUS Sham Procedure
Stanford University Medical Center
Stanford, California, United States
Palm Beach Neuroscience Institute/Sperling Medical Group
Responder Analysis
Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
Time frame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment
Severity of Device and Procedure related complications
To evaluate of the incidence and severity of device- and procedure-related
Time frame: At the time of ExAblate Pallidotomy procedure
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