NCT02319694

Brief Summary

This project studies the impulsive side effects of common treatments for Parkinson's Disease. By learning how parts of the brain involved in Parkinson's encode information related to reward and motivation, the investigators will better understand the reasons why Parkinson's patients often suffer from compulsive gambling, hypersexuality, and repetitive tinkering ("punding"). These results may lead to the design of better methods of deep brain stimulation (DBS) that minimize the behavioral side effects of Parkinson's treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

3.7 years

First QC Date

December 15, 2014

Last Update Submit

May 31, 2018

Conditions

Parkinson's Disease

Keywords

Basal GangliaBehaviorBehavioralBrainCognitiveComputer SimulationCuesDataDeep Brain StimulationDisease

Outcome Measures

Primary Outcomes (2)

  • Brain activity data

    Extracellular voltage measurements (microelectrode recording) from single and multi-neuron activity in the basal ganglia. Local field potentials from the same recording sites.

    during treatment

  • Behavioral data

    Interactions of patients with a video game task, including joystick button responses, points earned, and response times.

    during treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are patients scheduled to be implanted with Deep Brain Stimulation devices for treatment of Parkinson's Disease or Essential Tremor.

You may qualify if:

  • scheduled for implantation of deep brain stimulation device
  • appropriate for awake surgery
  • interest in participation

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseBehaviorDisease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 18, 2014

Study Start

July 1, 2013

Primary Completion

February 27, 2017

Study Completion

February 27, 2017

Last Updated

June 1, 2018

Record last verified: 2018-05