The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS.
The main questions it aims to answer are:
Does DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming?
Does this programming approach improve quality of life and motor symptoms compared with standard programming?
Researchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time.
Participants will:
Undergo DBS surgery using a clinically approved DBS system
Be randomly assigned to one of two DBS programming strategies
Wear inertial sensors at home for several days at different time points to objectively measure motor symptoms
Attend scheduled clinical visits for DBS programming and motor and non-motor assessments
Have adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins
Age between 30 and 70 years.
Confirmed diagnosis of idiopathic Parkinson's disease according to the MDS diagnostic criteria (Postuma et al., 2015).
Indication for deep brain stimulation surgery based on CAPSIT-PD criteria.
Presence of severe surgical complications (e.g., intracranial hemorrhage, infection).
Postoperative adverse events requiring electrode repositioning.
Any other medical or neurological condition that could interfere with safe participation in the trial.
Parallel
Conventional DBS Programming (Monopolar Review)
DeviceDBS programming performed using the conventional clinical monopolar review approach. Stimulation contacts and parameters are selected through systematic clinical testing based on clinician assessment of motor benefit and stimulation-related side effects, together with patient-reported symptoms. Programming does not incorporate postoperative electrode localization from neuroimaging or neurophysiological biomarkers. All participants are implanted with a CE-marked DBS system (Percept™ PC or RC with SenSight™ leads), and programming begins approximately 5 weeks after surgery following standard clinical practice. At 3 months after initial programming, Adaptive DBS is activated in all patients.
Objective-Guided DBS Programming (Imaging and Local Field Potential-Based)
DeviceDBS programming guided by objective anatomical and neurophysiological markers. Stimulation contact selection is informed by postoperative electrode reconstruction using Brainlab Elements™ and by LFP activity recorded with BrainSense™ from the implanted DBS system. These objective data are integrated with standard clinical testing to guide programming decisions. All participants are implanted with the same CE-marked DBS system (Percept™ PC or RC with SenSight™ leads), and programming starts approximately 5 weeks after surgery, following the same schedule as the comparator arm. At 3 months after initial programming, Adaptive DBS will be activated in all patients.
Change in Daily OFF Time Assessed by Wearable Sensors
Percentage change in daily time spent in the OFF state, measured objectively using PDMonitor® inertial sensors. OFF time will be quantified from continuous 7-day recordings performed at baseline (preoperative) and at 3 months after initiation of DBS programming. The outcome reflects motor fluctuations in real-life conditions.
Change in Quality of Life (PDQ-39 Total Score)
Change in health-related quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The total score and domain scores will be compared between baseline and 3 months after initiation of DBS programming to evaluate the impact of programming strategy on patient-reported outcomes.
Change in Motor Symptoms (MDS-UPDRS Part III)
Change in motor symptom severity assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. Scores obtained at baseline and at 3 months after initiation of DBS programming will be compared between groups.
Change in fluctuation severity (MDS-UPDRS Part IV)
Changes in fluctuation severity assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part IV. Scores obtained at baseline and at 3 months after initiation of DBS programming will be compared between groups.
Change in Non-Motor Symptoms (MDS-NMS)
Change in non-motor symptom burden assessed using the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS). Total scores will be compared between baseline and 3 months after initiation of DBS programming.
Effect of Adaptive DBS on Daily OFF Time Assessed by Wearable Sensors
Change in daily time spent in the OFF state assessed by PDMonitor® inertial sensors following activation of adaptive deep brain stimulation (aDBS). OFF time will be quantified from continuous 7-day recordings performed at 3 months after baseline (prior to initiation of aDBS programming) and at 6 months after baseline. Analyses are exploratory and descriptive. Between-group comparisons will also be performed as subgroup analyses according to assigned DBS programming strategy.
Effect of Adaptive DBS on Quality of Life (PDQ-39 Total Score)
Change in health-related quality of life assessed by the Parkinson's Disease Questionnaire-39 (PDQ-39) following activation of adaptive deep brain stimulation (aDBS). Total PDQ-39 scores obtained at 3 months after baseline (prior to initiation of aDBS programming) and at 6 months after baseline will be compared. Analyses are exploratory and descriptive. Between-group comparisons will also be performed as subgroup analyses according to assigned DBS programming strategy.
Effect of Adaptive DBS on Motor Symptoms (MDS-UPDRS Part III)
Descriptive evaluation of changes in motor symptom severity following activation of adaptive deep brain stimulation (aDBS), assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. Scores obtained at 3 months after baseline (prior to initiation of aDBS programming) and at 6 months after baseline will be compared. Analyses are exploratory and descriptive. Between-group comparisons will also be carried out as subgroup analyses according to assigned DBS programming strategy.
Effect of Adaptive DBS on Motor Fluctuations (MDS-UPDRS Part IV)
Descriptive evaluation of changes in motor fluctuation severity following activation of adaptive deep brain stimulation (aDBS), assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part IV. Scores obtained at 3 months after baseline (prior to initiation of aDBS programming) and at 6 months after baseline will be compared. Analyses are exploratory and descriptive. Between-group comparisons will also be carried out as subgroup analyses according to assigned DBS programming strategy.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Medtronic
Collaborator
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