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 study aims to find clinical, imaging, or blood markers that predict who will get the best motor and overall benefits from deep brain stimulation in Parkinson's. Participants are people already referred for standard DBS surgery, which uses implanted electrodes to send continuous electrical stimulation to brain targets such as the subthalamic nucleus or globus pallidus interna, calming abnormal movement circuits, improving tremor and slowness, and often allowing lower levodopa doses while treating dopamine-responsive symptoms. They are looking for adults 18 to 75 with clinically established, dopamine-responsive PD who have significant motor complications despite optimized meds, typically an off-med UPDRS motor score above 30, Hoehn and Yahr stage over 2.5 off meds, no major cognitive or psychiatric problems, and willingness to undergo DBS and blood sampling. The study is observational and plans to follow about 30 people to learn who benefits most rather than testing a new device.
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 study aims to find clinical, imaging, or blood markers that predict who will get the best motor and overall benefits from deep brain stimulation in Parkinson's. Participants are people already referred for standard DBS surgery, which uses implanted electrodes to send continuous electrical stimulation to brain targets such as the subthalamic nucleus or globus pallidus interna, calming abnormal movement circuits, improving tremor and slowness, and often allowing lower levodopa doses while treating dopamine-responsive symptoms. They are looking for adults 18 to 75 with clinically established, dopamine-responsive PD who have significant motor complications despite optimized meds, typically an off-med UPDRS motor score above 30, Hoehn and Yahr stage over 2.5 off meds, no major cognitive or psychiatric problems, and willingness to undergo DBS and blood sampling. The study is observational and plans to follow about 30 people to learn who benefits most rather than testing a new device.
- 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?
- 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 10 years.
- 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.