Reduce tremor and movement fluctuations
- Trial ID
- NCT06909045
- Official Title
- Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
- Goal
- Reduce tremor and movement fluctuations
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study Type
- INTERVENTIONAL
- Enrollment
- 130 participants
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Interventions
- Adaptive DBS, Continue DBS
Summary For Families
The goal is to see if adaptive stimulation of the subthalamic nucleus, which responds in real time to abnormal brain signals, controls motor symptoms and side effects better than the usual continuous DBS. Adaptive DBS uses the implanted Medtronic Percept system to monitor beta-band activity in the STN and automatically raise or lower stimulation when pathological beta rhythms appear, delivering stimulation only when needed; continuous DBS delivers a steady level all the time, and adaptive DBS is meant to work alongside levodopa and other meds rather than replace them. The trial is looking for adults 18 and older with idiopathic Parkinson's who already have bilateral Percept PC/RC STN leads, show a reliable beta peak in at least one STN, can recognize their ON/OFF motor states, can consent and understand Dutch; people with dementia, pregnancy, or participation in other neurological intervention trials are excluded.
Locations
- UZ Leuven, Leuven, Belgium
- Amsterdam UMC, Amsterdam, Netherlands
- Maastricht UMC+, Maastricht, Netherlands
- HagaZiekenhuis, The Hague, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Adaptive DBS. The goal is to see if adaptive stimulation of the subthalamic nucleus, which responds in real time to abnormal brain signals, controls motor symptoms and side effects better than the usual continuous DBS. Adaptive DBS uses the implanted Medtronic Percept system to monitor beta-band activity in the STN and automatically raise or lower stimulation when pathological beta rhythms appear, delivering stimulation only when needed; continuous DBS delivers a steady level all the time, and adaptive DBS is meant to work alongside levodopa and other meds rather than replace them. The trial is looking for adults 18 and older with idiopathic Parkinson's who already have bilateral Percept PC/RC STN leads, show a reliable beta peak in at least one STN, can recognize their ON/OFF motor states, can consent and understand Dutch; people with dementia, pregnancy, or participation in other neurological intervention trials are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 4 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 1 year.
- 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.