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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07215481
Status
Not Yet Recruiting

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Conditions

  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Shame Control (Baseline) — DEVICE
    Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
  • Standard of Care Deep Brain Stimulation — DEVICE
    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.
  • Illumina 3D Deep Brain Stimulation — DEVICE
    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.
  • Illumina 3D Deep Brain Stimulation Reduced Amplitude — DEVICE
    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.
  • Illumina 3D Deep Brain Stimulation Higher Amplitude — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Deep Brain Stimulation
    Participants start with a sham condition (baseline) for approximately 45 minutes. Participants then receive the following four deep brain stimulation conditions in a randomized order for approximately 45 minutes each delivered by the Boston Scientific Vercise Genus neurostimulator. Neither the participants nor the assessor will be aware of what condition they receive. Before starting the condition, there will be a wash in for approximately 15 minutes. Participants will then perform tasks and questionnaires for approximately 30 minutes on each condition. The four conditions are: 1. Standard of Care Deep Brain Stimulation 2. Illumina 3D Deep Brain Stimulation 3. Illumina 3D Deep Brain Stimulation Reduced Amplitude 4. Illumina 3D Deep Brain Stimulation Higher Amplitude

Primary Outcome Measure

Change in QDG Mobility Score (OFF DBS to Illumina 3D) [ Time Frame: Baseline and after 45 minutes of Illumina 3D DBS ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Neuroscience Health ClinicStanfordCalifornia94305-

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Stanford Neuroscience Health Clinic· Stanford, CA

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