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
Plain-Language Summary
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.