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NOT YET RECRUITING
NCT07215481
NA

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-12

Completion Date

2026-10

Last Updated

2025-10-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Stanford Neuroscience Health Clinic

Stanford, California, United States