DBS for Parkinson's (NCT07376278)
Predict benefit from brain stimulation
- Trial ID
- NCT07376278
- Official Title
- A Prospective Observational Study for the Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease
- Goal
- Predict benefit from brain stimulation
- Status
- RECRUITING
- Sponsor
- Hong Kong University of Science and Technology
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- Deep Brain Stimulation, PARKINSON DISEASE (Disorder)
- Interventions
- DBS
Summary For Families
The team wants to find blood-based signals that match good or poor outcomes after deep brain stimulation surgery for Parkinson's, test whether those signals can predict who will benefit, and see how they change before and after the operation. To do that, they will follow people already scheduled for deep brain stimulation, collect blood samples and any leftover brain tissue that naturally sticks to surgical instruments, and combine routine clinical scores with analyses of proteins, RNA, and genetic information; the surgery and usual care will not be changed, and researchers will use these data plus patient information to build a prediction model with explainable artificial intelligence. Adults aged 18 to 75 with established Parkinson's who are planning deep brain stimulation because medications are not adequately controlling motor problems, who respond to levodopa, and who do not have major psychiatric, cognitive, or other medical issues that would rule out surgery are eligible.
Locations
- The Hong Kong University of Science and Technology, Hong Kong, Hong Kong
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DBS. The team wants to find blood-based signals that match good or poor outcomes after deep brain stimulation surgery for Parkinson's, test whether those signals can predict who will benefit, and see how they change before and after the operation. To do that, they will follow people already scheduled for deep brain stimulation, collect blood samples and any leftover brain tissue that naturally sticks to surgical instruments, and combine routine clinical scores with analyses of proteins, RNA, and genetic information; the surgery and usual care will not be changed, and researchers will use these data plus patient information to build a prediction model with explainable artificial intelligence. Adults aged 18 to 75 with established Parkinson's who are planning deep brain stimulation because medications are not adequately controlling motor problems, who respond to levodopa, and who do not have major psychiatric, cognitive, or other medical issues that would rule out surgery are eligible.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 10 years.
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Blood draw (minimally invasive). Confirm the full schedule with the study coordinator.