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Trial record 10 of 27 for:    NINDS AND DBS AND Parkinson's

Neural Correlates of Cognition in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02975193
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
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 Procedure: Deep Brain Stimulation Surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : January 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: QUIP-RS

Procedure: Deep Brain Stimulation Surgery
DBS surgery for the implantation of electrodes for the treatment of motor disorders.




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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

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

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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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.

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02975193    
Other Study ID Numbers: IRB201601780
F30NS111841 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
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.

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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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases