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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
The 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.
UZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGAmsterdam UMC
Amsterdam, Netherlands
RECRUITINGMaastricht UMC+
Maastricht, Netherlands
NOT_YET_RECRUITINGHagaZiekenhuis
The Hague, Netherlands
NOT_YET_RECRUITINGHome 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
Time frame: change from baseline to six months of DBS
PD Home diary
ON time without troublesome dyskinesia
Time frame: during six months of follow-up
PD Home diary
ON time with troublesome dyskinesia
Time frame: during six months of follow-up
PD Home diary
ON time without dyskinesia
Time frame: during six months of follow-up
PD Home diary
OFF time
Time frame: during six months of follow-up
PD Home diary
Asleep time
Time frame: during six months of follow-up
MDS-UPDRS III (ON and OFF phase)
Motor symptoms
Time frame: change from baseline to six months of DBS
MDS-UPDRS IV
Motor complication including motor fluctuations and dyskinesias
Time frame: change from baseline to six months of DBS
Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase)
Level of physical disability
Time frame: change from baseline to six months of DBS
Parkinson's Disease Questionnaire 39 (PDQ-39)
Quality of life
Time frame: change from baseline to six months of DBS
Dopaminergic medication usage
Time frame: during six months of follow-up
Montreal Cognitive Assessment (MoCA)
MoCA is a cognitive screening tool for detecting and scoring cognitive impairment
Time frame: change from baseline to six months of DBS
Beck Depression Inventory (BDI)
Mood status
Time frame: change from baseline to six months of DBS
Starkstein Apathy Scale (SAS)
Apathy status
Time frame: change from baseline to six months of DBS
Parkinson's Disease Sleep Scale (PDSS-2)
Sleep disturbances and quality of sleep
Time frame: during six months of follow-up
Side effects
Number and sort of side effects
Time frame: during six months of follow-up
Time of DBS titration
Duration of DBS titration based on the number and duration of hospital visits
Time frame: during six months of follow-up
Time to final adjustment of the DBS settings
first time point for stimulation parameters following the last adjustment of the stimulation parameters
Time frame: during six months of follow-up
Assessor's evaluation of the ease of programming
Five-point Likert scale
Time frame: after six months of follow-up
Beta oscillatory activity
Amount of decrease of oscillatory activity in the beta range
Time frame: during six months of follow-up
DBS settings (1)
Electrical energy consumption expressed by the Total electrical energy delivered (TEED)
Time frame: during six months of follow-up
DBS settings (2)
DBS amplitudes in mA
Time frame: during six months of follow-up
DBS settings (3)
Average stimulation fraction expressed as percentages
Time frame: during six months of follow-up
LFP characteristics (2)
Beta power spectral density expressed as µV²/Hz
Time frame: during six months of follow-up
LFP characteristics (2)
Beta volatility expressed as a.u.
Time frame: during six months of follow-up
Participant's evaluation of the burden of the treatment
Five-point Likert scale
Time frame: after six months of follow-up
Participant's satisfaction on the outcome of treatment
Five-point Likert scale
Time frame: after six months of follow-up
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