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Neural Correlates of Cognition in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer task assessing cognition
Impulsive-Compulsive Disorders in Parkinson's Disease
Deep Brain Stimulation Surgery
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinsons Disease, Cognition

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

PD-DBS Participants:

  • Inclusion Criteria: Persons undergoing DBS surgery for the implantation of electrodes for the treatment of motor disorders
  • Exclusion Criteria: Failure of the DBS surgical candidacy screening process

Non-DBS PD Participants:

  • Inclusion Criteria:Persons diagnosed with idiopathic Parkinson's disease and have not received and are not currently scheduled for DBS.
  • Exclusion Criteria: Individuals that :

    • that have been diagnosed with dementia or other serious brain diseases or disorders such as strokes, traumatic brain injury, or brain tumor (the exception is Parkinson's disease)
    • who have had drug or alcohol abuse within the past 12 months
    • with severe sensory difficulties such as impaired vision or hearing
    • currently experiencing significant depression or sadness
    • with a history of schizophrenia or other serious mental health problems
    • using cognitive medications (e.g., Aricept) or stimulants (e.g., Adderall)
    • who have undergone deep brain stimulation, fetal cell implants, or other brain surgeries

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Parkinson's disease group with DBS

Arm Description

Healthy adults ages 18-90 without movement disorders, psychiatric disorders, or dementia. They will complete computer games and questionnaires at one time point. Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment

Parkinson's disease patients who have elected to receive DBS for treatment of their side effects of PD consent to complete computer games and questionnaires at baseline, computer games during deep brain stimulation, and computer games and questionnaires up to 2 years after surgery. Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment

Outcomes

Primary Outcome Measures

Change in behavioral performance
Behavioral performance will be assessed by the computer game that assess cognition. All computer games used in this study will have a similar form. The computer will record responses to each trial during the computer game.

Secondary Outcome Measures

Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
Assess the scores from a standard clinical questionnaire called QUIP-RS. Scores range from 0 to 112.
Local field potential brain signal
Measuring Brain signal while Parkinson's disease patients play a computer game during surgery. Local field potential is measured in Hertz (Hz)

Full Information

First Posted
November 10, 2016
Last Updated
February 11, 2021
Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02975193
Brief Title
Neural Correlates of Cognition in Parkinson's Disease
Official Title
Neural Correlates of Cognition in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 25, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now an evidence-based treatment for certain cases of PD, has the risk of causing deficits in multiple areas of cognition. As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by measuring brain signal activity while PD patients are engaged in cognition on a computer.
Detailed Description
Study Participants: For this study, the investigators will recruit 75 Parkinson's disease (PD) patients that are undergoing deep brain stimulation (DBS) as routine standard of care. Screening: For healthy control participants, investigators will approach adults, aged 18-90, for possible involvement in our study. Potential participants will be asked if they have ever been diagnosed with a movement disorder, psychiatric disorder, or dementia. For PD patients undergoing evaluation for DBS, investigators will first consult with their neurologist and neurosurgeon. Next, investigators will approach the participant and explain the study. PD Participants: As part of the usual DBS process at University of Florida (UF), PD participants will be asked to participate in this trial. There are three evaluation time points: before surgery, during surgery, and possibly after surgery. Before surgery, the PD patients will complete standardized questionnaires and be trained on a computer game to assess cognition. During surgery, the participants will play the same computer game while brain signals are recorded. When the patients return to University of Florida for DBS programming visits within 48 months after surgery, they will repeat the standardized questionnaires and computer game once again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinsons Disease, Cognition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy adults ages 18-90 without movement disorders, psychiatric disorders, or dementia. They will complete computer games and questionnaires at one time point. Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment
Arm Title
Parkinson's disease group with DBS
Arm Type
Active Comparator
Arm Description
Parkinson's disease patients who have elected to receive DBS for treatment of their side effects of PD consent to complete computer games and questionnaires at baseline, computer games during deep brain stimulation, and computer games and questionnaires up to 2 years after surgery. Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment
Intervention Type
Behavioral
Intervention Name(s)
Computer task assessing cognition
Intervention Description
Participants will complete a short computer game to assess cognition.
Intervention Type
Behavioral
Intervention Name(s)
Impulsive-Compulsive Disorders in Parkinson's Disease
Other Intervention Name(s)
QUIP-RS
Intervention Description
Standard clinical questionnaire
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation Surgery
Intervention Description
DBS surgery for the implantation of electrodes for the treatment of motor disorders.
Primary Outcome Measure Information:
Title
Change in behavioral performance
Description
Behavioral performance will be assessed by the computer game that assess cognition. All computer games used in this study will have a similar form. The computer will record responses to each trial during the computer game.
Time Frame
Baseline, before surgery, during surgery, and up to 2 years after surgery
Secondary Outcome Measure Information:
Title
Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
Description
Assess the scores from a standard clinical questionnaire called QUIP-RS. Scores range from 0 to 112.
Time Frame
Baseline, before surgery, during surgery, and up to 2 years after surgery
Title
Local field potential brain signal
Description
Measuring Brain signal while Parkinson's disease patients play a computer game during surgery. Local field potential is measured in Hertz (Hz)
Time Frame
At time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
PD-DBS Participants: Inclusion Criteria: Persons undergoing DBS surgery for the implantation of electrodes for the treatment of motor disorders Exclusion Criteria: Failure of the DBS surgical candidacy screening process Non-DBS PD Participants: Inclusion Criteria:Persons diagnosed with idiopathic Parkinson's disease and have not received and are not currently scheduled for DBS. Exclusion Criteria: Individuals that : that have been diagnosed with dementia or other serious brain diseases or disorders such as strokes, traumatic brain injury, or brain tumor (the exception is Parkinson's disease) who have had drug or alcohol abuse within the past 12 months with severe sensory difficulties such as impaired vision or hearing currently experiencing significant depression or sadness with a history of schizophrenia or other serious mental health problems using cognitive medications (e.g., Aricept) or stimulants (e.g., Adderall) who have undergone deep brain stimulation, fetal cell implants, or other brain surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysegul Gunduz, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.
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Neural Correlates of Cognition in Parkinson's Disease

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