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NCT Number: NCT02975193

Neural Correlates of Cognition in Parkinson's Disease

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer task assessing cognition

Behavioral

Participants will complete a short computer game to assess cognition.

Impulsive-Compulsive Disorders in Parkinson's Disease

Behavioral

Standard clinical questionnaire

Other names: QUIP-RS

Deep Brain Stimulation Surgery

Procedure

DBS surgery for the implantation of electrodes for the treatment of motor disorders.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2016
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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