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

Stanford University

Status: Not yet enrolling

Conditions: Parkinson's Disease (PD)

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07215481

83174

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Deep Brain Stimulation

Experimental group

Description:

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

Treatment:

Device: Illumina 3D Deep Brain Stimulation

Device: Standard of Care Deep Brain Stimulation

Device: Illumina 3D Deep Brain Stimulation Reduced Amplitude

Device: Shame Control (Baseline)

Device: Illumina 3D Deep Brain Stimulation Higher Amplitude