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Clinical Trials/NCT02975193
NCT02975193
Completed
Not Applicable

Neural Correlates of Cognition in Parkinson's Disease

University of Florida1 site in 1 country64 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Florida
Enrollment
64
Locations
1
Primary Endpoint
Change in behavioral performance
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
October 25, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • Local field potential brain signal(At time of surgery)

Study Sites (1)

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