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

March 30, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Yale University
Rune Labs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-31239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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