Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming

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

Conditions

• Parkinson's Disease
• Parkinson
• Parkinsons Disease (PD)
• Motor Fluctuations
• DBS
• Deep Brain Stimulation

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2028-03-01

Completion

2028-09-01

FDA Device

Yes

Countries

• Spain

Study Locations