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.
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
Dementia
Unable or unwilling to come OFF DBS for a short period of time
Single group
Shame Control (Baseline)
DeviceParticipant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
Standard of Care Deep Brain Stimulation
DeviceParticipant'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
DeviceParticipant'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
DeviceParticipant'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
DeviceParticipant'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.
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.
Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D)
A single score representing the proportion and amplitude of tremor-identified strikes using an engineered Keyduo QDG device. It is represented by a single value between 0 and 100, where 100 represents the worst tremor severity. A secondary outcome is the difference in QDG Tremor Severity 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
Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D)
The proportion of tremor-identified strikes using an engineered Keyduo QDG device. Range from 0 to 100%. A secondary outcome is the difference in QDG Percent Rest Trremor 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
Change in QDG Press Amplitude (OFF DBS to Illumina 3D)
The average amplitude of strikes using an engineered Keyduo QDG device. Ranges from 0 to 14 mm. A secondary outcome is the difference in QDG Press Amplitude 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
Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D)
The coefficient of variation of press amplitude of strikes using an engineered Keyduo QDG device. A secondary outcome is the difference in QDG Press Amplitude Coefficient of Variation 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
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Stanford University
Lead sponsor
Boston Scientific Corporation
Collaborator
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