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

NCT07215481 | Not Yet Recruiting FDA Device

• 1 other identifier: 83174
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

deep brain stimulation; DBS; PD; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change in QDG Mobility Score (OFF DBS to Illumina 3D)

  Quantitative Digitography (QDG) Mobility Score is a single score representing a participant's overall movement proficiency by combining performance across different aspects of movement including speed, frequency, amplitude, and rhythmicity measured using an engineered Keyduo QDG device during an alternating finger pressing and releasing with the index and middle finger. It is represented by a single value between 0 and 100 for each hand, where 100 represents ideal performance. The primary outcome is the difference in QDG Mobility Score from the OFF DBS condition (baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG mobility score will be used.

  Baseline and after 45 minutes of Illumina 3D DBS

Secondary Outcomes (33)

• Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D)

  Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS

• Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D)

  Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS

• Change in QDG Press Amplitude (OFF DBS to Illumina 3D)

  Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS

• Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D)

  Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS

• Change in QDG Interstrike Interval (OFF DBS to Illumina 3D)

  Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

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

Device: Shame Control (Baseline); Device: Standard of Care Deep Brain Stimulation; Device: Illumina 3D Deep Brain Stimulation; Device: Illumina 3D Deep Brain Stimulation Reduced Amplitude; Device: Illumina 3D Deep Brain Stimulation Higher Amplitude

Interventions

Shame Control (Baseline) DEVICE

Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.

Deep Brain Stimulation

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.

Deep Brain Stimulation

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.

Deep Brain Stimulation

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.

Deep Brain Stimulation

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.

Deep Brain Stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease (PD)
• Newly implanted or soon to be implanted with deep brain stimulation (Boston Scientific device)
• Willingness to withdraw from clinical medication regimen when necessary for research visits

You may not qualify if:

• Dementia
• Unable or unwilling to come OFF DBS for a short period of time

Sponsors & Collaborators

• Stanford University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Stanford Neuroscience Health Clinic

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Helen Bronte-Stewart, MD, MSE

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Neurological Sciences

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 10, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)