This multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system.
The aim of the study is to identify which patients benefit most from aDBS, and to explore patient and LFP signal characteristics as well as stimulation parameters as potential predictors of treatment preference and efficacy. The study utilizes a blinded, randomized N-of-1 trial design, where each patient tests the following:
* Optimized cDBS settings (O-cDBS); * Optimized aDBS settings (O-aDBS) Each setting is evaluated for a minimum of 2 and maximum of 7 days at home in a randomized order (patient blinded).
The main study outcome consists of the patient's final preference among the two DBS programs: O-cDBS, or O-aDBS. Secondary outcomes focus on differences between O-cDBS and O-aDBS regarding the following parameters (among others):
* Quality of life (PDQ-39); * Patient satisfaction (5-point Likert Scale); * (Non)-motor fluctuations (MDS-UPDRS-III + MDS-NMS-Q); * Time spent in "ON"/"OFF" motor phases (symptom diary + MDS-UPDRS IV); * Time spent experiencing dyskinesia (symptom diary + MDS-UPDRS IV); * Time spent with the most bothersome symptom (symptom diary + MDSUPDRS IV); * Stimulation parameters; * Local field potentials.
The study also incorporates real-world home-based assessments using the Experience Sampling Method (ESM) to capture motor and non-motor symptom fluctuations in daily life and identify differences among the three settings.
Patients with Parkinson's disease with bilateral DBS in the STN
DBS surgery with implantation of the Percept™ PC/RC system performed at least 6 months ago
Symptoms such as dysarthria, freezing, or ON-OFF fluctuations that are insufficiently controlled
A usable LFP signal is present on at least one side
Patients for whom switching to aDBS, operating the remote control independently, or making regular visits to the DBS center is deemed clinically unsafe or unreliable by the treating physician - for example, due to active or unstable cognitive or psychiatric conditions.
High impedance, defective DBS electrodes, or insufficient LFP signal quality, or bilateral stimulation primarily on the most ventral or dorsal contact points, preventing proper functioning of aDBS.
Patients who have objected to the use of their electronic health record data for medical scientific research.
Sequential
Optimized conventional DBS
DeviceTreatment for a minimum of 2 to a maximum of 7 days with a previously optimized version of the patient's original conventional DBS (O-cDBS) settings.
Optimized adaptive DBS
DeviceTreatment for a minimum of 2 to a maximum of 7 days with previously optimized adaptive DBS (O-aDBS) settings.
Patient preference of DBS settings
The patient's choice for one of the two program options (O-cDBS, or O-aDBS)
Quality of life per DBS settings
The 39 item Parkinson's Disease Questionnaire (PDQ-39) score for O-cDBS and O-aDBS (score between 0 (good quality) and 100 (bad quality))
General Prompt Experience Sampling Method score per DBS settings
Custom general prompt daily (non-)motor fluctuations questionnaire via Experience Sampling Method (ESM), with a score ranging from 0 (good) to 270 (poor)
Patient satisfaction per DBS settings
5-point Likert scale score for patient satisfaction with O-cDBS and O-aDBS (1=very dissatisfied; 2= dissatisfied; 3=neutral; 4=satisfied; 5=very satisfied)
Time spent in ON/OFF per DBS settings according to symptom diary
Percentage of time spent in OFF during time awake for O-cDBS and O-aDBS according to symptom diary (0% (good) to 100% (poor)).
Cognitive functioning at baseline
Montreal Cognitive Assessment (MoCA) score at baseline (no more than 6 months old), with a score ranging from 0 (poor) to 30 (good).
Disease duration at baseline
Disease duration in years at baseline (study start)
Age at baseline
Age in years at baseline (study start)
Biological sex
Biologically determined sex at baseline
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HagaZiekenhuis
Lead sponsor
Maastricht University Medical Center
Collaborator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Collaborator
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