Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming
Stanford University
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.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceShame Control (Baseline)
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
- DeviceStandard 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.
- DeviceIllumina 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.
- DeviceIllumina 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.
- DeviceIllumina 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.
Location
- Stanford Neuroscience Health ClinicStanford, California