Actively Recruiting
Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-01-29
130
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
H
HagaZiekenhuis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two types of deep brain stimulation (DBS) treatments, adaptive DBS (aDBS) and continuous DBS (cDBS), in people with Parkinson's disease. The main goal is to see if aDBS increases the daily average time patients spend in an ON state without troublesome involuntary movements more than cDBS over six months. This study involves patients who already have Medtronic Percept DBS electrodes implanted targeting specific brain areas. Participants will first have their devices set to continuous DBS during an initial programming visit. Two weeks later, they will be randomly assigned to either continue with cDBS or switch to aDBS, where the device adapts stimulation based on brain signals. The study follows participants for six months, with check-ins at three and six months. Throughout the study, participants will complete Parkinson's disease home diaries at several time points to track symptoms. During the study, researchers will monitor changes using the home diary from baseline through six months. Other assessments include motor function scales (MDS-UPDRS III and IV), cognitive tests, mood and sleep questionnaires, medication use, and brain signal measurements. Safety and side effects will also be tracked. Participants will be evaluated on treatment burden and satisfaction after six months. Overall participation lasts about six months after device programming.
CONDITIONS
Brief Title
Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic Parkinson's disease based on the UK Brain Bank criteria
- Age older than 18 years
- Previous implantation of Medtronic Percept bilateral DBS electrodes targeting the subthalamic nucleus
- Optimal contact point compatible with adaptive DBS in at least one subthalamic nucleus
- Presence of a reliable beta peak in at least one subthalamic nucleus
- Able to provide informed consent and comply with the study protocol
- Understand the Dutch language
You will not qualify if you...
- Legally incompetent adults
- Participation in other clinical trials involving neurological interventions
- Inability to recognize the difference between motor ON and OFF states
- Mild cognitive impairment or dementia
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive either adaptive or continuous subthalamic nucleus deep brain stimulation using the Medtronic Percept device.
Multiple visits during 6 months of treatment
Trial Site Locations
Total: 4 locations
1
UZ Leuven
Leuven, Belgium
Not Yet Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
3
Maastricht UMC+
Maastricht, Netherlands
Not Yet Recruiting
4
HagaZiekenhuis
The Hague, Netherlands
Not Yet Recruiting
Research Team
M
M. Beudel, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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