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

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

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.

Sponsors & Collaborators

• Boston Scientific Corporation

  collaborator INDUSTRY

• Stanford University

  lead OTHER

Principal Investigators

• Helen Bronte-Stewart, MD, MSE · Stanford University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-06-30

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations