Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).
This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 10 sites. Subjects will undergo an Exablate index procedure targeting the PTT and will be seen at 1-week,1-, 3-, and 6- months post treatment. At the 6-month visit, subjects will be evaluated for an Exablate procedure on the other side.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Exablate Pallidothalamic Tractotomy
Stanford
Palo Alto, California, United States
Delray Medical Center
Delray Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Maryland, Baltimore
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication
OFF-medication, Upper + Lower Extremity motor score from the MDS-UPDRS Part III comparing Month 3 post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.
Time frame: Up to Month 3 post Bilateral Treatment
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part II
MDS-UPDRS Part II - Activities of Daily living comparing all Bilateral scheduled visits to Baseline. Lower score on the scale means a better outcome.
Time frame: Up to Month 12 post Bilateral Treatment
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Baltimore, Maryland, United States
New York University Langone
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Neurology, Hospital Universitario HM Puerta del Sur (HM CINAC)
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Chang Bing Show Chwan Memorial Hospital
Lugang, Changhua County, Taiwan