Clinical trial NCT02975193: Neural Correlates of Cognition in Parkinson's Disease
Official title: Neural Correlates of Cognition in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinsons Disease
Cognition
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2016-11-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Change in behavioral performance
timeFrame: Baseline, before surgery, during surgery, and up to 2 years after surgery
Secondary outcomes:
measure: Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
timeFrame: Baseline, before surgery, during surgery, and up to 2 years after surgery
measure: Local field potential brain signal
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Aysegul Gunduz, PhD
role: PRINCIPAL_INVESTIGATOR
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