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.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Medtronic
Collaborator