Understanding Motivation in Parkinson's Patients Through Neurophysiology

Study Overview
=================
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.

Official Title
-----------------
Understanding Motivation in Parkinson's Patients Through Neurophysiology

Conditions
-----------------
Parkinson Disease, Deep Brain Stimulation, Motivation

Intervention / Treatment
-----------------
* Other: Stimulation on
* Other: Stimulation off
* Behavioral: Decision Making Task


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Within subject crossover counterbalanced study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation<br>Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept PC device. | Other: Stimulation on<br>* Stimulation from Percept PC DBS will be on while the patient is playing a decision-making game on a computer-based application.<br>* Other names: Medtronic Percept PC;Behavioral: Decision Making Task<br>* Patients will be playing a decision making task through a computer-based application.<br>|
| Experimental: No Stimulation<br>Patients will have stimulation turned off through their Medtronic Percept PC device. | Other: Stimulation off<br>* Stimulation from Percept PC DBS will be off while the patient is playing a decision-making game on a computer-based application.<br>* Other names: Medtronic Percept PC;Behavioral: Decision Making Task<br>* Patients will be playing a decision making task through a computer-based application.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's, Medtronic, Percept PC, DBS, Deep Brain Stimulation, Parkinson's Disease, Parkinson Disease, PD, Reward-based decision making, Task, Percept