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.
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;
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;
Parallel
Adaptive DBS
Other interventionThe Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
Continue DBS
Other interventionThe Medtronic Percept device will be equipped with aDBS functionality (to maintain the blinding of the allocation), but this functionality will remain inactive. Participant will receive continue DBS.
Home PD diary
The primary outcome is the comparison between the aDBS group and the cDBS group of the change from baseline to six months in mean daily ON time without troublesome dyskinesia. Daily ON time without troublesome dyskinesia is measured with the PD home diary. The PD home diary is a self-reported tool for tracking motor symptoms in Parkinson's patients every 30 minutes for three days within a one-week window
PD Home diary
ON time without troublesome dyskinesia
PD Home diary
ON time with troublesome dyskinesia
PD Home diary
ON time without dyskinesia
PD Home diary
OFF time
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
HagaZiekenhuis
Collaborator
Maastricht University Medical Center
Collaborator
Universitair Ziekenhuis Leuven
Collaborator
