Clinical trial NCT05065151: Understanding Motivation in Parkinson's Patients Through Neurophysiology
Official title: Understanding Motivation in Parkinson's Patients Through Neurophysiology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Deep Brain Stimulation
Motivation
Keywords: Parkinson's
Medtronic
Percept
DBS
Deep Brain Stimulation
Parkinson's Disease
Parkinson Disease
PD
Reward-based decision making
Task
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Yale University
name: Rune Labs
name: University of Birmingham
First posted: 2021-10-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subject crossover counterbalanced study.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Risky Decisions made with Percept DBS stimulation on for Parkinson's Disease Patients
timeFrame: 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
measure: Percent of Risky Decisions made with Percept DBS stimulation off for Parkinson's Disease Patients
timeFrame: 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
measure: Reaction Time During Decision-Making Task
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Task Success Rate
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Acceptance Rate of Risky Versus Safe Options
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Force Exertion During Motor Responses
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Low frequency local field potentials
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Electroencephalogram (EEG) theta band power
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Electroencephalogram (EEG) beta band power
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Electroencephalogram (EEG) gamma band power
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
measure: Electroencephalogram (EEG) alpha band power
timeFrame: The values will be collected starting from admission in clinic. Data collection and analysis of said values can take up to three years.
Secondary outcomes:
measure: Interaction Between Neural Low Frequency Power in the LFP with Reaction Time (seconds)
timeFrame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
measure: Interaction Between Neural Low Frequency Power in the LFP with Success Rate (percentage)
timeFrame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
measure: Interaction Between Neural Low Frequency Power in the LFP with Force Exerted (arbitrary units)
timeFrame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
measure: Interaction Between Neural Low Frequency Power in the EEG with Reaction Time (seconds)
timeFrame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
measure: Interaction Between Neural Low Frequency Power in the EEG with Success Rate (percentage)
timeFrame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
measure: Interaction Between Neural Low Frequency Power in the EEG with Force Exerted (arbitrary units)
timeFrame: Analysis will occur continuously throughout the study period (up to three years) based on collected behavioral and neural data.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Simon J Little, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.