NCT05065151

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
56mo left

Started Oct 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Oct 2021Dec 2030

First Submitted

Initial submission to the registry

September 17, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

October 30, 2021

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

9.1 years

First QC Date

September 17, 2021

Last Update Submit

April 7, 2025

Conditions

Parkinson DiseaseDeep Brain StimulationMotivation

Keywords

Parkinson'sMedtronicPerceptDBSDeep Brain StimulationParkinson's DiseaseParkinson DiseasePDReward-based decision makingTask

Outcome Measures

Primary Outcomes (11)

  • Percent of Risky Decisions made with Percept DBS stimulation on for Parkinson's Disease Patients

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +1 more secondary outcomes

Study Arms (2)

Stimulation

EXPERIMENTAL

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

Other: Stimulation onBehavioral: Decision Making Task

No Stimulation

EXPERIMENTAL

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

Other: Stimulation offBehavioral: Decision Making Task

Interventions

Stimulation onOTHER

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

Also known as: Medtronic Percept
Stimulation
Stimulation offOTHER

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

Also known as: Medtronic Percept
No Stimulation
Decision Making TaskBEHAVIORAL

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

No StimulationStimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe cognitive impairments
  • Has MOCA score below 20
  • Pregnancy
  • Age less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 25092308BACKGROUND

  • 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.

    PMID: 26156984BACKGROUND

  • 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.

    PMID: 26545853BACKGROUND

  • 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.

    PMID: 33200989BACKGROUND

  • 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.

    PMID: 39746820BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Simon J Little, MBBS, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Wang, PhD

CONTACT

415-353-7885Sarah.Wang@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Within subject crossover counterbalanced study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 1, 2021

Study Start

October 30, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)