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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.