Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shame Control (Baseline), Standard of Care Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation Reduced Amplitude.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease (PD). Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming
Overview
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.
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.
Primary outcome measures
- Change in QDG Mobility Score (OFF DBS to Illumina 3D) [Time frame: Baseline and after 45 minutes of Illumina 3D DBS]
Secondary outcome measures (12)
- Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Press Amplitude (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Interstrike Interval (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Release Slope (OFF DBS to Illumina 3D). [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Press Speed (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Interstrike Interval Coefficient of Variation (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in QDG Percent Freezing (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in Gait Speed (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in Gait Arrhythmicity (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
- Change in MDS-UPDRS III Total Score (OFF DBS to Illumina 3D) [Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford Neuroscience Health Clinic — Stanford
Identifiers
NCT: NCT07215481 · 83174