NCT07105280Not yet recruiting
Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- HagaZiekenhuis
- Diseases
- Parkinson disease
- NCT number
- NCT07105280
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Oct 2026 to the primary completion date, 1 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.