An interventional study of Computer task assessing cognition and Impulsive-Compulsive Disorders in Parkinson's Disease in Parkinson Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by University of Florida · Not applicable, Interventional, and Basic science
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 64 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
PD-DBS Participants:
Non-DBS PD Participants:
Exclusion Criteria: Individuals that :
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 · Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease
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 · Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease · Procedure: Deep Brain Stimulation Surgery
Participants will complete a short computer game to assess cognition.
Standard clinical questionnaire
Also known as: QUIP-RS
DBS surgery for the implantation of electrodes for the treatment of motor disorders.
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.
Time frame: Baseline, before surgery, during surgery, and up to 2 years after surgery
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.
Time frame: Baseline, before surgery, during surgery, and up to 2 years after surgery
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)
Time frame: At time of surgery
Plan to share: Yes — IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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