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Neural Correlates of Cognition in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02975193
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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
Parkinson Disease Behavioral: Computer task assessing cognition Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease Behavioral: Montreal Cognitive Assessment Not Applicable

Detailed Description:

Study Participants: For this study, the investigators will recruit approximately 40 healthy control participants and 40 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.

Healthy Controls: Healthy controls will complete standardized questionnaires and play a computer game to assess cognition, taking no longer than 30 minutes.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : February 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group

Healthy adults ages 21-90 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 Name: QUIP-RS

Behavioral: Montreal Cognitive Assessment
Standard clinical questionnaire
Other Name: MoCA

Experimental: Parkinson's disease group

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 Name: QUIP-RS

Behavioral: Montreal Cognitive Assessment
Standard clinical questionnaire
Other Name: MoCA




Primary Outcome Measures :
  1. Change in behavioral performance [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Controls:

  • Inclusion criteria: Healthy adults between the ages of 18-90.
  • Exclusion Criteria: Participants that have known movement disorders, psychiatric disorders, or any type of dementia.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975193


Contacts
Contact: Aysegul Gunduz, PhD 352-273-6877 agunduz@bme.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Aysegul Gunduz, PhD University of Florida

Publications:
Baunez, C., & Lardeux, S. (2011, October). Frontal cortex-like functions of the subthalamic nucleus. In Basal Ganglia X-Proceedings of the 10th Triennial Meeting of the International Basal Ganglia Society. Frontiers E-books.
Gabrieli, J. D., Singh, J., Stebbins, G. T., & Goetz, C. G. (1996). Reduced working memory span in Parkinson's disease: Evidence for the role of frontostriatal system in working and strategic memory. Neuropsychology, 10(3), 322.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02975193     History of Changes
Other Study ID Numbers: IRB201601780
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Parkinsons Disease
Cognition

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases