Understanding Motivation in Parkinson's Patients Through Neurophysiology (MPPN)

April 7, 2025 updated by: University of California, San Francisco
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Simon J Little, MBBS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation
Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept device.
Patients will be playing a decision making task through a computer-based application.
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
Experimental: No Stimulation
Patients will have stimulation turned off through their Medtronic Percept device.
Patients will be playing a decision making task through a computer-based application.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Risky Decisions made with Percept DBS stimulation on for Parkinson's Disease Patients
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.
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
Percent of Risky Decisions made with Percept DBS stimulation off for Parkinson's Disease Patients
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.
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
Reaction Time During Decision-Making 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.
The investigators will measure the time it takes for patients to make each decision on the value-based decision-making task in the clinic.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Task Success Rate
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Acceptance Rate of Risky Versus Safe Options
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Force Exertion During Motor 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.
Force data will be recorded during motor responses to evaluate physical engagement and motor control during task performance.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Low frequency local field potentials
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Electroencephalogram (EEG) theta band power
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Electroencephalogram (EEG) beta band power
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Electroencephalogram (EEG) gamma band power
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Electroencephalogram (EEG) alpha band power
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.
The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interaction Between Neural Low Frequency Power in the LFP with Reaction Time (seconds)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Simon J Little, MBBS, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Future data sharing will be covered by UCSF data sharing compliance rules.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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