Brain Signal and Imaging-Guided Versus Standard Deep Brain Stimulation Programming in Parkinson's Disease
Compares two ways of setting deep brain stimulation in adults with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 70 years old?
Source: NCT07369310, who can take part
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Trial code
- NCT07369310
- Record updated
- 27 January 2026
- Original description
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.Read full original descriptionShow less
Randomized Trial on DBS Programming Based on Biomarkers vs. Standard Monopolar Review
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
Inclusion: 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.
Exclusion: Presence of severe surgical complications (e.g., intracranial hemorrhage, infection); Any other medical or neurological condition that could interfere with safe participation in the trial; Postoperative adverse events requiring electrode repositioning.