University of California San Francisco
San Francisco, California, 94158, United States
Location status: Recruiting
Location contact
Sarah Wang, PhD
CONTACT
Simon J Little, MBBS, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05065151
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94158, United States
Location status: Recruiting
Sarah Wang, PhD
CONTACT
Simon J Little, MBBS, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stimulation from Percept DBS will be on while the patient is playing a decision-making game on a computer-based application.
Other names: Medtronic Percept
Stimulation from Percept DBS will be off while the patient is playing a decision-making game on a computer-based application.
Other names: Medtronic Percept
Patients will be playing a decision making task through a computer-based application.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
We will assess the effect of reaction time on low frequency power in the LFP data (theta, alpha, beta power) recorded from the Percept device with statistical modeling.
Time frame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
We will assess the effect of success rate on low frequency power in the LFP data (theta, alpha, beta power) recorded from the Percept device with statistical modeling.
Time frame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
We will assess the effect of force exerted on low frequency power in the LFP data (theta, alpha, beta power) recorded from the Percept device with statistical modeling.
Time frame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
We will assess the effect of reaction time on low frequency power in the EEG data (theta, alpha, beta power) recorded from the Percept device with statistical modeling.
Time frame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
We will assess the effect of success rate on low frequency power in the EEG data (theta, alpha, beta power) recorded from the Percept device with statistical modeling.
Time frame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
We will assess the effect of force exerted on low frequency power in the EEG data (theta, alpha, beta power) recorded from the Percept device with statistical modeling.
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Acronym: MPPN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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