Neural Correlates of Cognition in Parkinson's Disease

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02975193
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
64
1
2
44.7
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computer task assessing cognition
  • Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease
  • Procedure: Deep Brain Stimulation Surgery
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neural Correlates of Cognition in Parkinson's Disease
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Oct 25, 2020
Actual Study Completion Date :
Oct 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

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

Behavioral: Computer task assessing cognition
Participants will complete a short computer game to assess cognition.

Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease
Standard clinical questionnaire
Other Names:
  • QUIP-RS
  • Active Comparator: Parkinson's disease group with DBS

    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

    Behavioral: Computer task assessing cognition
    Participants will complete a short computer game to assess cognition.

    Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease
    Standard clinical questionnaire
    Other Names:
  • QUIP-RS
  • Procedure: Deep Brain Stimulation Surgery
    DBS surgery for the implantation of electrodes for the treatment of motor disorders.

    Outcome Measures

    Primary Outcome Measures

    1. Change in behavioral performance [Baseline, before surgery, during surgery, and up to 2 years after surgery]

      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

    1. Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) [Baseline, before surgery, during surgery, and up to 2 years after surgery]

      Assess the scores from a standard clinical questionnaire called QUIP-RS. Scores range from 0 to 112.

    2. Local field potential brain signal [At time of surgery]

      Measuring Brain signal while Parkinson's disease patients play a computer game during surgery. Local field potential is measured in Hertz (Hz)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32611

    Sponsors and Collaborators

    • University of Florida
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Aysegul Gunduz, PhD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02975193
    Other Study ID Numbers:
    • IRB201601780
    • F30NS111841
    First Posted:
    Nov 29, 2016
    Last Update Posted:
    Feb 15, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Florida
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2021