NCT07215481

Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease

Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate an automated deep brain stimulation (DBS) algorithm developed by Boston Scientific called Illumina 3D for motor symptoms in Parkinson's disease (PD). The main question it aims to answer is: Is this new automated algorithm effective for treating motor symptoms of PD. Fifteen participants are anticipated to be enrolled. Participants are individuals who recently were implanted with DBS in the subthalamic nucleus as part of their regular clinical treatment and are scheduled to have their DBS turned ON for the first time. In addition to their regular clinical visit when their DBS is turned ON by their clinician, participants are tested on DBS settings determined by Illumina 3D (an automated algorithm). Participants are tested on these different settings across different motor tasks, including walking and finger tapping, as well as answering questionnaires. The experiment is expected to last 1 or 2 days; this is not a longitudinal or long-term trial. Participants return to their usual DBS settings once they leave the clinic.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DEVICE	Shame Control (Baseline)	Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
DEVICE	Standard of Care Deep Brain Stimulation	Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined as standard of care by the clinician.
DEVICE	Illumina 3D Deep Brain Stimulation	Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm.
DEVICE	Illumina 3D Deep Brain Stimulation Reduced Amplitude	Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a reduced stimulation amplitude.
DEVICE	Illumina 3D Deep Brain Stimulation Higher Amplitude	Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a higher stimulation amplitude.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-10-10
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study