Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease (NCT07105280) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease
Netherlands30 participantsStarted 2025-10-01
Plain-language summary
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:
* Original cDBS settings (cDBS);
* 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 three DBS programs: original cDBS, O-cDBS, or O-aDBS. Secondary outcomes focus on differences between cDBS, 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring patient preference of DBS settings using brain signals called local field potentials — what does that actually mean in practice, and would my DBS device need to be surgically changed or reprogrammed as part of this study?
2Since this trial isn't recruiting yet, how long might it be before it opens, and should I be pursuing standard DBS programming in the meantime rather than waiting?
3The trial is listed as 'Phase NA,' which often means it's more of a device or procedure study than a drug trial — what does that tell us about how much is already known about the safety of this closed-loop approach compared to my current or planned DBS therapy?
4How does this 'closed-loop' refinement of DBS settings differ from the standard way my DBS would normally be adjusted, and what would be asked of me in terms of visits, tests, or device monitoring if I were to eventually participate?
5Given that this trial focuses on patient preference as its main outcome rather than a clinical measure like motor function, would it complement or potentially interfere with the standard Parkinson's care I'd be receiving at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient preference of DBS settings
Timeframe: after the three week trial phase of the study