Comparing two brain stimulation settings for Parkinson's disease patients
Compares standard and adaptive deep brain stimulation settings in people with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease
Key facts
- Where
- Amsterdam and Maastricht, NetherlandsSee the 2 sites
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsNo longer taking part
- Maastricht UMCMaastricht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HagaZiekenhuis
- Trial code
- NCT07105280
- Record updated
- 10 September 2026
- Original description
This multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system.Read full original descriptionShow less
Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease
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.
Inclusion: 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.
Exclusion: 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.