Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Summary
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
Official title: Randomized Trial on DBS Programming Based on Biomarkers vs. Standard Monopolar Review
Key Details
Gender
All
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-03-01
Completion Date
2028-09-01
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
Conventional DBS Programming (Monopolar Review)
DBS 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)
DBS 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.
Locations (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain