Understanding Motivation in Parkinson's Patients Through Neurophysiology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent of Risky Decisions made with Percept DBS stimulation on for Parkinson's Disease Patients
研究概览
简要总结
The study aims to better understand motivation and value-based decision-making in Parkinson's patients through neurophysiology using Medtronic's Percept DBS device. By combining behavioral tasks with neural recordings, the study seeks to uncover how DBS affects motivation, particularly in relation to effort, reward, and timing.
详细描述
Participants will perform reward-based decision-making tasks designed to assess both self-benefitting and prosocial motivation. The tasks will evaluate how effort and reward influence decision-making, as well as how proximity to a deadline impacts choices. These tasks will be conducted in both clinic and home settings.
Throughout the study, participants will remain on their regular dopaminergic medications. Each participant will complete sessions under two stimulation conditions: their usual DBS settings and with DBS turned off. Neural activity will be recorded using the Percept device, which enables real-time and chronic at-home data streaming. Additionally, participants will wear a device that captures movement, sleep, heart rate variability, and self-reported measures.
The primary outcomes are behavioral: changes in reaction time, acceptance rate, and success rate across different DBS conditions. The secondary outcomes focus on identifying neural oscillatory biomarkers time-locked to specific decision-making events. By linking brain activity to motivational behavior, this study aims to advance our understanding of non-motor symptoms in PD and inform the development of adaptive DBS algorithms targeting these symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has Parkinson's Disease or Dystonia
- •Has Medtronic Percept or RC+S DBS device implanted in either GPI or STN
- •Has DBS device implanted either bilaterally or unilaterally
- •Male or female
- •More than 1 month post-DBS surgery
排除标准
- •Severe cognitive impairments
- •Has MOCA score below 20
- •Pregnancy
- •Age less than 18 years old
研究组 & 干预措施
Stimulation
Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept device.
干预措施: Stimulation on (Other)
Stimulation
Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept device.
干预措施: Decision Making Task (Behavioral)
No Stimulation
Patients will have stimulation turned off through their Medtronic Percept device.
干预措施: Stimulation off (Other)
No Stimulation
Patients will have stimulation turned off through their Medtronic Percept device.
干预措施: Decision Making Task (Behavioral)
结局指标
主要结局
Percent of Risky Decisions made with Percept DBS stimulation on for Parkinson's Disease Patients
时间窗: The values will be collected starting from admission in clinic and the at-home paradigm. Data collection and analysis of said values can take up to three years
Patients' responses on the tablet will be recorded in-clinic and at home. The investigators will tally their choices from the value-based decision making game (risky versus safe decisions) and report an average of risky responses.
Percent of Risky Decisions made with Percept DBS stimulation off for Parkinson's Disease Patients
时间窗: The values will be collected starting from admission in clinic and the at-home paradigm. Data collection and analysis of said values can take up to three years
Patients' responses on the tablet will be recorded in-clinic and at home. The investigators will tally their choices from the value-based decision making game (risky versus safe decisions) and report an average of risky responses.
Reaction Time During Decision-Making Task
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
The investigators will measure the time it takes for patients to make each decision on the value-based decision-making task in the clinic.
Task Success Rate
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
The investigators will calculate the percentage of trials in which patients complete the task successfully according to predefined task performance criteria.
Acceptance Rate of Risky Versus Safe Options
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
The proportion of trials where patients accept risky versus safe options will be calculated and compared across stimulation ON and OFF conditions.
Force Exertion During Motor Responses
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Force data will be recorded during motor responses to evaluate physical engagement and motor control during task performance.
Low frequency local field potentials
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Local field potentials (LFPs) will be recorded from the implanted Percept device to evaluate neural activity during decision making under different stimulation conditions. Low frequency power will be calculated during specific time intervals during the task. Cardiac artifact will be removed with electrocardiogram (ECG) measurements recorded during the same task.
Electroencephalogram (EEG) theta band power
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Scalp EEG will be recorded concurrently with task performance to assess cortical activity patterns during decision-making. Average theta band power will be calculated in specific time intervals during the task.
Electroencephalogram (EEG) beta band power
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Scalp EEG will be recorded concurrently with task performance to assess cortical activity patterns during decision-making. Average beta band power will be calculated in specific time intervals during the task.
Electroencephalogram (EEG) gamma band power
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Scalp EEG will be recorded concurrently with task performance to assess cortical activity patterns during decision-making. Average gamma band power will be calculated in specific time intervals during the task.
Electroencephalogram (EEG) alpha band power
时间窗: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Scalp EEG will be recorded concurrently with task performance to assess cortical activity patterns during decision-making. Average alpha band power will be calculated in specific time intervals during the task.
次要结局
- Interaction Between Neural Low Frequency Power in the LFP with Reaction Time (seconds)(Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.)
- Interaction Between Neural Low Frequency Power in the LFP with Success Rate (percentage)(Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.)
- Interaction Between Neural Low Frequency Power in the LFP with Force Exerted (arbitrary units)(Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.)
- Interaction Between Neural Low Frequency Power in the EEG with Reaction Time (seconds)(Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.)
- Interaction Between Neural Low Frequency Power in the EEG with Success Rate (percentage)(Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.)
- Interaction Between Neural Low Frequency Power in the EEG with Force Exerted (arbitrary units)(Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.)