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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05065151
Other study ID # 20-31239
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2021
Est. completion date October 1, 2024

Study information

Verified date March 2023
Source University of California, San Francisco
Contact Julia Sun, BA
Phone 415-502-9992
Email julia.sun@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has Parkinson's Disease - Has Medtronic Percept PC DBS device implanted in either GPI or STN Exclusion Criteria: - Severe cognitive impairments

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco Rune Labs, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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