Understanding Motivation in Parkinson's Patients Through Neurophysiology

NCT ID: NCT05065151

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-30

Study Completion Date

2030-12-01

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Deep Brain Stimulation Motivation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Within subject crossover counterbalanced study.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Stimulation

Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept device.

Group Type EXPERIMENTAL

Stimulation on

Intervention Type OTHER

Stimulation from Percept DBS will be on while the patient is playing a decision-making game on a computer-based application.

Decision Making Task

Intervention Type BEHAVIORAL

Patients will be playing a decision making task through a computer-based application.

No Stimulation

Patients will have stimulation turned off through their Medtronic Percept device.

Group Type EXPERIMENTAL

Stimulation off

Intervention Type OTHER

Stimulation from Percept DBS will be off while the patient is playing a decision-making game on a computer-based application.

Decision Making Task

Intervention Type BEHAVIORAL

Patients will be playing a decision making task through a computer-based application.

Interventions

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Stimulation on

Stimulation from Percept DBS will be on while the patient is playing a decision-making game on a computer-based application.

Intervention Type OTHER

Stimulation off

Stimulation from Percept DBS will be off while the patient is playing a decision-making game on a computer-based application.

Intervention Type OTHER

Decision Making Task

Patients will be playing a decision making task through a computer-based application.

Intervention Type BEHAVIORAL

Other Intervention Names

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Medtronic Percept Medtronic Percept

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Rune Labs

UNKNOWN

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon J Little, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Wang, PhD

Role: CONTACT

415-353-7885

Facility Contacts

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Sarah Wang, PhD

Role: primary

415-353-7885

References

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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.

Reference Type BACKGROUND
PMID: 25092308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26156984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26545853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33200989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39746820 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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20-31239

Identifier Type: -

Identifier Source: org_study_id

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