Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
Recruiting · NCT06909045 · Interventional (participants receive a specific treatment) · Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is: \- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period? Researchers will compare aDBS to regular continue deep brain stimulation (cDBS). Participants will: * be set up to cDBS during the first programming visit (visit 2); * be randomized 1:1 to aDBS or cDBS two weeks after visit 2; * follow-up will be at three and six months after visit 2; * complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.
Who can take part
Inclusion criteria
- Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);
- Age older than 18 years;
- Previous implantation of Medtronic PerceptTM PC/RC DBS electrodes bilateral targeting the STN;
- Optimal contact point compatible with aDBS in at least one STN;
- Reliable beta peak in at least one STN;
- Able to provide informed consent and comply with the study protocol;
- Understand the Dutch language.
Exclusion criteria
- Legally incompetent adults;
- Patients with ongoing participation in other clinical trials involving neurological interventions;
- Inability to recognize the difference between the motor ON or OFF state;
- Mild cognitive impairment or dementia;
- Pregnancy.
Where it is running
4 locations listed.
- Amsterdam UMC - Amsterdam, Netherlands
- UZ Leuven - Leuven, Belgium
- Maastricht UMC+ - Maastricht, Netherlands
- HagaZiekenhuis - The Hague, Netherlands