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

Primary Purpose

Parkinson Disease, Deep Brain Stimulation, Motivation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulation on
Stimulation off
Decision Making Task
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinson's, Medtronic, Percept PC, DBS, Deep Brain Stimulation, Parkinson's Disease, Parkinson Disease, PD, Reward-based decision making, Task, Percept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe cognitive impairments

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stimulation

No Stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent of Risky Decisions made with Percept PC 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.
Percent of Risky Decisions made with Percept PC 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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2021
Last Updated
March 30, 2023
Sponsor
University of California, San Francisco
Collaborators
Yale University, Rune Labs
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1. Study Identification

Unique Protocol Identification Number
NCT05065151
Brief Title
Understanding Motivation in Parkinson's Patients Through Neurophysiology
Acronym
MPPN
Official Title
Understanding Motivation in Parkinson's Patients Through Neurophysiology
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Yale University, Rune Labs

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Deep Brain Stimulation, Motivation
Keywords
Parkinson's, Medtronic, Percept PC, DBS, Deep Brain Stimulation, Parkinson's Disease, Parkinson Disease, PD, Reward-based decision making, Task, Percept

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within subject crossover counterbalanced study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation
Arm Type
Experimental
Arm Description
Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept PC device.
Arm Title
No Stimulation
Arm Type
Experimental
Arm Description
Patients will have stimulation turned off through their Medtronic Percept PC device.
Intervention Type
Other
Intervention Name(s)
Stimulation on
Other Intervention Name(s)
Medtronic Percept PC
Intervention Description
Stimulation from Percept PC DBS will be on while the patient is playing a decision-making game on a computer-based application.
Intervention Type
Other
Intervention Name(s)
Stimulation off
Other Intervention Name(s)
Medtronic Percept PC
Intervention Description
Stimulation from Percept PC DBS will be off while the patient is playing a decision-making game on a computer-based application.
Intervention Type
Behavioral
Intervention Name(s)
Decision Making Task
Intervention Description
Patients will be playing a decision making task through a computer-based application.
Primary Outcome Measure Information:
Title
Percent of Risky Decisions made with Percept PC DBS stimulation on for Parkinson's Disease Patients
Description
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.
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
Title
Percent of Risky Decisions made with Percept PC DBS stimulation off for Parkinson's Disease Patients
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has Parkinson's Disease Has Medtronic Percept PC DBS device implanted in either GPI or STN Exclusion Criteria: Severe cognitive impairments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Sun, BA
Phone
415-502-9992
Email
julia.sun@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Merrick, PhD
Email
christina.merrick@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon J Little, MBBS, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Sun, BA
Email
julia.sun@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Simon J Little, MBBS, PhD
First Name & Middle Initial & Last Name & Degree
Christina M Merrick, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Future data sharing will be covered by UCSF data sharing compliance rules.
Citations:
PubMed Identifier
25092308
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.
Results Reference
background
PubMed Identifier
26156984
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.
Results Reference
background
PubMed Identifier
26545853
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.
Results Reference
background
PubMed Identifier
33200989
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.
Results Reference
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Understanding Motivation in Parkinson's Patients Through Neurophysiology

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