NCT02975193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

November 10, 2016

Last Update Submit

February 11, 2021

Conditions

Parkinson Disease

Keywords

Parkinsons DiseaseCognition

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, before surgery, during surgery, and up to 2 years after surgery

Secondary Outcomes (2)

  • 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 Arms (2)

Control group

ACTIVE COMPARATOR

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 cognitionBehavioral: Impulsive-Compulsive Disorders in Parkinson's Disease

Parkinson's disease group with DBS

ACTIVE COMPARATOR

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 cognitionBehavioral: Impulsive-Compulsive Disorders in Parkinson's DiseaseProcedure: Deep Brain Stimulation Surgery

Interventions

Computer task assessing cognitionBEHAVIORAL

Participants will complete a short computer game to assess cognition.

Control groupParkinson's disease group with DBS
Impulsive-Compulsive Disorders in Parkinson's DiseaseBEHAVIORAL

Standard clinical questionnaire

Also known as: QUIP-RS
Control groupParkinson's disease group with DBS
Deep Brain Stimulation SurgeryPROCEDURE

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

Parkinson's disease group with DBS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Non-DBS PD Participants:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (16)

  • Allcock LM, Rowan EN, Steen IN, Wesnes K, Kenny RA, Burn DJ. Impaired attention predicts falling in Parkinson's disease. Parkinsonism Relat Disord. 2009 Feb;15(2):110-5. doi: 10.1016/j.parkreldis.2008.03.010. Epub 2008 May 19.

    PMID: 18487069BACKGROUND

  • Awh E, Vogel EK, Oh SH. Interactions between attention and working memory. Neuroscience. 2006 Apr 28;139(1):201-8. doi: 10.1016/j.neuroscience.2005.08.023. Epub 2005 Dec 1.

    PMID: 16324792BACKGROUND

  • Baunez C, Lardeux S. Frontal cortex-like functions of the subthalamic nucleus. Front Syst Neurosci. 2011 Oct 11;5:83. doi: 10.3389/fnsys.2011.00083. eCollection 2011.

    PMID: 22013416BACKGROUND

  • Filoteo JV, Delis DC, Salmon DP, Demadura T, Roman MJ, Shults CW. An examination of the nature of attentional deficits in patients with Parkinson's disease: evidence from a spatial orienting task. J Int Neuropsychol Soc. 1997 Jul;3(4):337-47.

    PMID: 9260443BACKGROUND

  • 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.

    BACKGROUND

  • Henry JD, Crawford JR. Verbal fluency deficits in Parkinson's disease: a meta-analysis. J Int Neuropsychol Soc. 2004 Jul;10(4):608-22. doi: 10.1017/S1355617704104141.

    PMID: 15327739BACKGROUND

  • Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. doi: 10.1038/35058500.

    PMID: 11256080BACKGROUND

  • Jahanshahi M, Ardouin CM, Brown RG, Rothwell JC, Obeso J, Albanese A, Rodriguez-Oroz MC, Moro E, Benabid AL, Pollak P, Limousin-Dowsey P. The impact of deep brain stimulation on executive function in Parkinson's disease. Brain. 2000 Jun;123 ( Pt 6):1142-54. doi: 10.1093/brain/123.6.1142.

    PMID: 10825353BACKGROUND

  • Kim HJ, Jeon BS, Paek SH. Nonmotor Symptoms and Subthalamic Deep Brain Stimulation in Parkinson's Disease. J Mov Disord. 2015 May;8(2):83-91. doi: 10.14802/jmd.15010. Epub 2015 May 31.

    PMID: 26090080BACKGROUND

  • Klepac N, Trkulja V, Relja M, Babic T. Is quality of life in non-demented Parkinson's disease patients related to cognitive performance? A clinic-based cross-sectional study. Eur J Neurol. 2008 Feb;15(2):128-33. doi: 10.1111/j.1468-1331.2007.02011.x.

    PMID: 18217883BACKGROUND

  • Lord S, Rochester L, Hetherington V, Allcock LM, Burn D. Executive dysfunction and attention contribute to gait interference in 'off' state Parkinson's Disease. Gait Posture. 2010 Feb;31(2):169-74. doi: 10.1016/j.gaitpost.2009.09.019. Epub 2009 Nov 5.

    PMID: 19896382BACKGROUND

  • Middleton FA, Strick PL. Basal ganglia output and cognition: evidence from anatomical, behavioral, and clinical studies. Brain Cogn. 2000 Mar;42(2):183-200. doi: 10.1006/brcg.1999.1099.

    PMID: 10744919BACKGROUND

  • Mimura M, Oeda R, Kawamura M. Impaired decision-making in Parkinson's disease. Parkinsonism Relat Disord. 2006 Apr;12(3):169-75. doi: 10.1016/j.parkreldis.2005.12.003. Epub 2006 Mar 23.

    PMID: 16563850BACKGROUND

  • Nakano K, Kayahara T, Tsutsumi T, Ushiro H. Neural circuits and functional organization of the striatum. J Neurol. 2000 Sep;247 Suppl 5:V1-15. doi: 10.1007/pl00007778.

    PMID: 11081799BACKGROUND

  • Rafal RD, Posner MI, Walker JA, Friedrich FJ. Cognition and the basal ganglia. Separating mental and motor components of performance in Parkinson's disease. Brain. 1984 Dec;107 ( Pt 4):1083-94. doi: 10.1093/brain/107.4.1083.

    PMID: 6509309BACKGROUND

  • Williams AE, Arzola GM, Strutt AM, Simpson R, Jankovic J, York MK. Cognitive outcome and reliable change indices two years following bilateral subthalamic nucleus deep brain stimulation. Parkinsonism Relat Disord. 2011 Jun;17(5):321-7. doi: 10.1016/j.parkreldis.2011.01.011. Epub 2011 Feb 11.

    PMID: 21316292BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aysegul Gunduz, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 29, 2016

Study Start

February 1, 2017

Primary Completion

October 25, 2020

Study Completion

October 25, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.

Locations

US(1)