Neural Correlates of Cognition in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Neural Correlates of Cognition in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975193
• Other study ID #: IRB201601780
• Secondary ID: F30NS111841
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 25, 2020

Study information

• Verified date: February 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 25, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Computer task assessing cognition
Participants will complete a short computer game to assess cognition.
• Impulsive-Compulsive Disorders in Parkinson's Disease
Standard clinical questionnaire

Procedure:
• Deep Brain Stimulation Surgery
DBS surgery for the implantation of electrodes for the treatment of motor disorders.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Awh E, Vogel EK, Oh SH. Interactions between attention and working memory. Neuroscience. 2006 Apr 28;139(1):201-8. Epub 2005 Dec 1. Review. — View Citation

Baunez, C., & Lardeux, S. (2011, October). Frontal cortex-like functions of the subthalamic nucleus. In Basal Ganglia X-Proceedings of the 10th Triennial Meeting of the International Basal Ganglia Society. Frontiers E-books.

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. — View Citation

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.

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

Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Middleton FA, Strick PL. Basal ganglia output and cognition: evidence from anatomical, behavioral, and clinical studies. Brain Cogn. 2000 Mar;42(2):183-200. Review. — View Citation

Mimura M, Oeda R, Kawamura M. Impaired decision-making in Parkinson's disease. Parkinsonism Relat Disord. 2006 Apr;12(3):169-75. Epub 2006 Mar 23. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, before surgery, during surgery, and up to 2 years after surgery
Secondary	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)	At time of surgery