NCT07369310Not yet recruiting
Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming
Randomized Trial on DBS Programming Based on Biomarkers vs. Standard Monopolar Review
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Diseases
- Parkinson disease
- NCT number
- NCT07369310
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Mar 2026 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Postoperative adverse events requiring electrode repositioning.
Who the study is looking for
- 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.
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.