Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in QDG Mobility Score (OFF DBS to Illumina 3D)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable or unwilling to come OFF DBS for a short period of time
研究组 & 干预措施
Deep Brain Stimulation
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:
- Standard of Care Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation Reduced Amplitude
- Illumina 3D Deep Brain Stimulation Higher Amplitude
干预措施: Shame Control (Baseline) (Device)
Deep Brain Stimulation
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:
- Standard of Care Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation Reduced Amplitude
- Illumina 3D Deep Brain Stimulation Higher Amplitude
干预措施: Standard of Care Deep Brain Stimulation (Device)
Deep Brain Stimulation
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:
- Standard of Care Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation Reduced Amplitude
- Illumina 3D Deep Brain Stimulation Higher Amplitude
干预措施: Illumina 3D Deep Brain Stimulation (Device)
Deep Brain Stimulation
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:
- Standard of Care Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation Reduced Amplitude
- Illumina 3D Deep Brain Stimulation Higher Amplitude
干预措施: Illumina 3D Deep Brain Stimulation Reduced Amplitude (Device)
Deep Brain Stimulation
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:
- Standard of Care Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation
- Illumina 3D Deep Brain Stimulation Reduced Amplitude
- Illumina 3D Deep Brain Stimulation Higher Amplitude
干预措施: Illumina 3D Deep Brain Stimulation Higher Amplitude (Device)
结局指标
主要结局
Change in QDG Mobility Score (OFF DBS to Illumina 3D)
时间窗: Baseline and after 45 minutes of Illumina 3D DBS
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.
次要结局
- 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)
- Change in QDG Release Slope (OFF DBS to Illumina 3D).(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in QDG Press Speed (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in QDG Interstrike Interval Coefficient of Variation (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in QDG Percent Freezing (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in Gait Speed (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in Gait Arrhythmicity (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in MDS-UPDRS III Bradykinesia Subscore (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in MDS-UPDRS III Rigidity Subscore (OFF DBS to Illumina 3D(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in MDS-UPDRS III Tremor Subscore (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in MDS-UPDRS III Axial Subscore (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in MDS-UPDRS III Total Score (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in QDG Percent Rest Tremor (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in MDS-UPDRS III Tremor Subscore (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in MDS-UPDRS III Axial Subscore (OFF DBS to Illumina 3D)(Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS)
- Change in QDG Mobility Score (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Tremor Severity Score (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Press Amplitude (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Press Amplitude Coefficient of Variation (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Interstrike Interval (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Release Slope (SoC DBS to Illumina 3D).(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Percent Freezing (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Press Speed (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in Gait Arrhythmicity (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in QDG Interstrike Interval Coefficient of Variation (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in Gait Speed (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in MDS-UPDRS III Total Score (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in MDS-UPDRS III Bradykinesia Subscore (SoC DBS to Illumina 3D)(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
- Change in MDS-UPDRS III Rigidity Subscore (SoC DBS to Illumina 3D(After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS)
研究者
Helen M. Bronte-Stewart
Professor of Neurology and Neurological Sciences
Stanford University