Reduce medication refractory motor complications
- Trial ID
- NCT05539196
- Official Title
- A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
- Goal
- Reduce medication refractory motor complications
- Status
- RECRUITING
- Sponsor
- InSightec
- Study Type
- OBSERVATIONAL
- Enrollment
- 60 participants
- Conditions
- Movement Disorders, Neurology, Parkinsons Disease
- Interventions
- Exablate Pallidotomy, Unilateral
Plain-Language Summary
The goal is to track real-world outcomes after using Exablate pallidotomy to reduce medication-refractory moderate to severe motor complications in people with advanced, idiopathic Parkinson's disease. The approach uses the Exablate 4000 MR-guided focused ultrasound device to make a precise, one-time lesion in the globus pallidus on one side of the brain, interrupting abnormal circuits that cause dyskinesia and motor fluctuations without open surgery. It is meant for problems that do not respond well to levodopa and other meds; it may reduce troublesome dyskinesia or off periods but does not directly replace levodopa. The registry is enrolling adults aged 30 to 99 who are already planning a unilateral Exablate procedure at their treating center and who can consent and complete follow-up visits.
Locations
- University of Maryland, Baltimore, Baltimore, Maryland, United States
- Weill Cornell Medicine, New York, New York, United States
- University of Pennsylvania, Philadelphia, Pennsylvania, United States
- University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Ohnishi Neurological Center, Akashi, Hyōgo, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exablate Pallidotomy, Unilateral. The goal is to track real-world outcomes after using Exablate pallidotomy to reduce medication-refractory moderate to severe motor complications in people with advanced, idiopathic Parkinson's disease. The approach uses the Exablate 4000 MR-guided focused ultrasound device to make a precise, one-time lesion in the globus pallidus on one side of the brain, interrupting abnormal circuits that cause dyskinesia and motor fluctuations without open surgery. It is meant for problems that do not respond well to levodopa and other meds; it may reduce troublesome dyskinesia or off periods but does not directly replace levodopa. The registry is enrolling adults aged 30 to 99 who are already planning a unilateral Exablate procedure at their treating center and who can consent and complete follow-up visits.
- Who can participate?
- Participants must be between 30 Years and 99 Years.
- Where is this trial located?
- This trial is recruiting at 5 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 6 years and 6 months.