Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• Men and women, age 30 years and older, desiring bilateral treatment option with second side staged at 6 months.
• Subject is able and willing to give informed consent and able to attend all study visits
• Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
• Motor complications of PD on optimum medical treatment
• Subject is on a stable dose of all PD medications for 30 days prior to screening visit
• Subject is able to communicate sensations during the Exablate procedure.
Locations
United States
California
Stanford
Palo Alto
Florida
Delray Medical Center
Delray Beach
Illinois
Rush University Medical Center
Chicago
Maryland
University of Maryland, Baltimore
Baltimore
New York
New York University Langone
New York
Weill Cornell Medicine
New York
Other Locations
Spain
Neurology, Hospital Universitario HM Puerta del Sur (HM CINAC)
Madrid
Clínica Universidad de Navarra
Pamplona
Taiwan
Chang Bing Show Chwan Memorial Hospital
Lugang
Time Frame
Start Date: 2021-05-14
Completion Date: 2028-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Exablate Pallidothalamic Tractotomy
Exablate treatment for Advanced Idiopathic Parkinson's Disease
Authors
Cruz Rodríguez Oroz, Arif Dalvi, Alon Mogilner, Vivek Buch, Michael Kaplitt, Howard Eisenberg, Harini Sarva, Paul Fishman, Michele Matarazzo
Related Therapeutic Areas
Sponsors
Leads: InSightec