Exablate Pallidotomy, Unilateral for Parkinson's (NCT05539196)
Reduce involuntary movements and stiffness
- 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 involuntary movements and stiffness
- Status
- RECRUITING
- Sponsor
- InSightec
- Study Type
- OBSERVATIONAL
- Enrollment
- 60 participants
- Conditions
- Movement Disorders, Neurology, Parkinsons Disease
- Interventions
- Exablate Pallidotomy, Unilateral
Summary For Families
A post-approval registry is tracking people with advanced Parkinson's whose motor problems are not helped by medication, to see how they do after a one-sided pallidotomy performed with the Exablate Neuro device. It will follow about 60 people at around 10 centers worldwide, with visits before the procedure, at 3, 6, and 12 months, and then yearly up to five years, collecting safety reports, medication use, standard movement and involuntary movement ratings, quality of life, clinician and patient impressions of change, and patient satisfaction. Adults aged 30 and older who are scheduled to have the Exablate one-sided pallidotomy as part of their usual care, who can attend follow-up visits and have given informed consent, are eligible; people who do not agree or cannot commit to the follow-up are excluded.
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. A post-approval registry is tracking people with advanced Parkinson's whose motor problems are not helped by medication, to see how they do after a one-sided pallidotomy performed with the Exablate Neuro device. It will follow about 60 people at around 10 centers worldwide, with visits before the procedure, at 3, 6, and 12 months, and then yearly up to five years, collecting safety reports, medication use, standard movement and involuntary movement ratings, quality of life, clinician and patient impressions of change, and patient satisfaction. Adults aged 30 and older who are scheduled to have the Exablate one-sided pallidotomy as part of their usual care, who can attend follow-up visits and have given informed consent, are eligible; people who do not agree or cannot commit to the follow-up are excluded.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 6 years and 6 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Study visits occur at Baseline, 3 months, 6 months, 12 months, and annually thereafter for 5 years.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.