Adaptive DBS for Parkinson's (NCT06909045)
Increase daily good movement hours
- Trial ID
- NCT06909045
- Official Title
- Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
- Goal
- Increase daily good movement hours
- 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 a version of deep brain stimulation that adjusts how it delivers pulses can increase the daily hours people spend in a good motor state without troublesome involuntary movements, compared with the usual constant stimulation, over six months. Participants are first set to the regular stimulation, then two weeks later are randomly switched to either the adaptive or the continuous setting and followed at three and six months while keeping a Parkinson’s home diary to track daily ON time without troublesome involuntary movements. The study is enrolling adults with idiopathic Parkinson’s who already have the specific implanted deep brain stimulation system used in the trial, have at least one electrode contact and a clear brain signal suitable for the adaptive setting, can tell when their medication is working, can give consent, and understand Dutch. People with significant memory problems, pregnancy, or who are taking part in other neurological intervention trials are not eligible; about 130 people are planned to join.
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 a version of deep brain stimulation that adjusts how it delivers pulses can increase the daily hours people spend in a good motor state without troublesome involuntary movements, compared with the usual constant stimulation, over six months. Participants are first set to the regular stimulation, then two weeks later are randomly switched to either the adaptive or the continuous setting and followed at three and six months while keeping a Parkinson’s home diary to track daily ON time without troublesome involuntary movements. The study is enrolling adults with idiopathic Parkinson’s who already have the specific implanted deep brain stimulation system used in the trial, have at least one electrode contact and a clear brain signal suitable for the adaptive setting, can tell when their medication is working, can give consent, and understand Dutch. People with significant memory problems, pregnancy, or who are taking part in other neurological intervention trials are not eligible; about 130 people are planned to join.
- 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?
- 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 1 year.
- 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.