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Understanding Motivation in Parkinson's Patients Through Neurophysiology (MPPN)

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ClinicalTrials.gov Identifier: NCT05065151
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : March 23, 2022
Sponsor:
Collaborators:
Yale University
Rune Labs
Information provided by (Responsible Party):
University of California, San Francisco

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
Parkinson Disease Deep Brain Stimulation Motivation Other: Stimulation on Other: Stimulation off Behavioral: Decision Making Task Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : October 30, 2021
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Medtronic Percept PC

Behavioral: Decision Making Task
Patients will be playing a decision making task through a computer-based application.




Primary Outcome Measures :
  1. Percent of Risky Decisions made with Percept PC 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.

  2. Percent of Risky Decisions made with Percept PC 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has Parkinson's Disease
  • Has Medtronic Percept PC DBS device implanted in either GPI or STN

Exclusion Criteria:

  • Severe cognitive impairments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065151


Contacts
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Contact: Julia Sun, BA 415-502-9992 julia.sun@ucsf.edu
Contact: Christina Merrick, PhD christina.merrick@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Julia Sun, BA       julia.sun@ucsf.edu   
Principal Investigator: Simon J Little, MBBS, PhD         
Sub-Investigator: Christina M Merrick, PhD         
Sponsors and Collaborators
University of California, San Francisco
Yale University
Rune Labs
Investigators
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Principal Investigator: Simon J Little, MBBS, PhD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05065151    
Other Study ID Numbers: 20-31239
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Future data sharing will be covered by UCSF data sharing compliance rules.

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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:
Parkinson's
Medtronic
Percept PC
DBS
Deep Brain Stimulation
Parkinson's Disease
Parkinson Disease
PD
Reward-based decision making
Task
Percept
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases