MPPN: Understanding Motivation in Parkinson's Patients Through Neurophysiology

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065151
Collaborator
Yale University (Other), Rune Labs (Other)
20
1
2
34.1
0.6

Study Details

Study Description

Brief Summary

The study's aim is to better understand motivation and value-based decision making in Parkinson's patients through neurophysiology using Medtronic's Percept PC DBS device.

Condition or Disease Intervention/Treatment Phase
  • Other: Stimulation on
  • Other: Stimulation off
  • Behavioral: Decision Making Task
N/A

Detailed Description

The investigators will ask patients to complete reward-based decision making tasks in clinic and at home in the presence and absence of Percept PC deep brain stimulation and medication. The Percept PC device has the ability to stream data during paradigms and chronically at home. Patients at home will also be fitted with a wearable device which records motion, sleep, heart rate variability, and self-reported metrics. The investigators will use spectral techniques and statistical analysis to identify the relationship between brain signals and motivation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Within subject crossover counterbalanced study.Within subject crossover counterbalanced study.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Understanding Motivation in Parkinson's Patients Through Neurophysiology
Actual Study Start Date :
Oct 30, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stimulation

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

Other: Stimulation on
Stimulation from Percept PC DBS will be on while the patient is playing a decision-making game on a computer-based application.
Other Names:
  • Medtronic Percept PC
  • Behavioral: Decision Making Task
    Patients will be playing a decision making task through a computer-based application.

    Experimental: No Stimulation

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

    Other: Stimulation off
    Stimulation from Percept PC DBS will be off while the patient is playing a decision-making game on a computer-based application.
    Other Names:
  • Medtronic Percept PC
  • Behavioral: Decision Making Task
    Patients will be playing a decision making task through a computer-based application.

    Outcome Measures

    Primary Outcome Measures

    1. Percent of Risky Decisions made with Percept PC DBS stimulation on for Parkinson's Disease Patients [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.

    2. Percent of Risky Decisions made with Percept PC DBS stimulation off for Parkinson's Disease Patients [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Has Parkinson's Disease

    • Has Medtronic Percept PC DBS device implanted in either GPI or STN

    Exclusion Criteria:
    • Severe cognitive impairments

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94158

    Sponsors and Collaborators

    • University of California, San Francisco
    • Yale University
    • Rune Labs

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05065151
    Other Study ID Numbers:
    • 20-31239
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by University of California, San Francisco
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2022