- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05065151
Understanding Motivation in Parkinson's Patients Through Neurophysiology (MPPN)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Wang, PhD
- Phone Number: 415-353-7885
- Email: Sarah.Wang@ucsf.edu
Study Locations
-
-
California
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San Francisco, California, United States, 94158
- Recruiting
- University of California San Francisco
-
Contact:
- Sarah Wang, PhD
- Phone Number: 415-353-7885
- Email: Sarah.Wang@ucsf.edu
-
Principal Investigator:
- Simon J Little, MBBS, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
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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:
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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.
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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.
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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
Investigators
- Principal Investigator: Simon J Little, MBBS, PhD, University of California, San Francisco
Publications and helpful links
General Publications
- Rutledge RB, Skandali N, Dayan P, Dolan RJ. A computational and neural model of momentary subjective well-being. Proc Natl Acad Sci U S A. 2014 Aug 19;111(33):12252-7. doi: 10.1073/pnas.1407535111. Epub 2014 Aug 4.
- Rutledge RB, Skandali N, Dayan P, Dolan RJ. Dopaminergic Modulation of Decision Making and Subjective Well-Being. J Neurosci. 2015 Jul 8;35(27):9811-22. doi: 10.1523/JNEUROSCI.0702-15.2015.
- Eldar E, Rutledge RB, Dolan RJ, Niv Y. Mood as Representation of Momentum. Trends Cogn Sci. 2016 Jan;20(1):15-24. doi: 10.1016/j.tics.2015.07.010. Epub 2015 Nov 3.
- Blain B, Rutledge RB. Momentary subjective well-being depends on learning and not reward. Elife. 2020 Nov 17;9:e57977. doi: 10.7554/eLife.57977.
- Talbot J, Cutler J, Tamm M, Little SJ, Harmer CJ, Husain M, Lockwood PL, Apps MAJ. Dopamine boosts motivation for prosocial effort in Parkinson's disease. J Neurosci. 2025 Jan 2:e1593242024. doi: 10.1523/JNEUROSCI.1593-24.2024. Online ahead of print.
- Pisauro MA, Pollicino D, Fisher L, Apps MAJ. Neural and computational mechanisms of effort under the pressure of a deadline. bioRxiv. 2024. doi:10.1101/2024.04.17.589910.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-31239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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