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Understanding Motivation in Parkinson's Patients Through Neurophysiology

Not Applicable
Recruiting
Conditions
Motivation
Parkinson Disease
Deep Brain Stimulation
Interventions
Other: Stimulation on
Other: Stimulation off
Behavioral: Decision Making Task
Registration Number
NCT05065151
Lead Sponsor
University of California, San Francisco
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria
  • 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
Exclusion Criteria
  • Severe cognitive impairments
  • Has MOCA score below 20
  • Pregnancy
  • Age less than 18 years old

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
StimulationStimulation onPatients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept PC device.
StimulationDecision Making TaskPatients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept PC device.
No StimulationStimulation offPatients will have stimulation turned off through their Medtronic Percept PC device.
No StimulationDecision Making TaskPatients will have stimulation turned off through their Medtronic Percept PC device.
Primary Outcome Measures
NameTimeMethod
Percent of Risky Decisions made with Percept DBS stimulation on for Parkinson's Disease PatientsThe 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 PatientsThe 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 TaskThe 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 RateThe 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 OptionsThe 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 ResponsesThe 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 potentialsThe 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 powerThe 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 powerThe 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 powerThe 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 powerThe 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.

Secondary Outcome Measures
NameTimeMethod
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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Trial Locations

Locations (1)

University of California San Francisco

🇺🇸

San Francisco, California, United States

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