Parkinson DiseaseNCT02975193
Neural Correlates of Cognition in Parkinson's Disease
A study testing Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease and Deep Brain Stimulation Surgery in people with Parkinson Disease, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease and Deep Brain Stimulation Surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 25 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Deep Brain Stimulation Surgery
- Keywords
- Parkinsons Disease, Cognition
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer task assessing cognitionBehavioural
Participants will complete a short computer game to assess cognition.
Impulsive-Compulsive Disorders in Parkinson's DiseaseBehavioural
Also called QUIP-RS
Standard clinical questionnaire
Deep Brain Stimulation SurgeryProcedure or surgery
DBS surgery for the implantation of electrodes for the treatment of motor disorders.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Computer task assessing cognition; Behavioral: 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 Receives: Behavioral: Computer task assessing cognition; Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease; Procedure: Deep Brain Stimulation Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Assess the scores from a standard clinical questionnaire called QUIP-RS. Scores range from 0 to 112.
Measured: 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)
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Feb 2017
- Primary completion25 Oct 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysegul Gunduz, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975193
- Sponsor's protocol ID
- IRB201601780
- Other IDs
- F30NS111841
- Status last verified
- Feb 2021
- First submitted
- 10 Nov 2016
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.
Publications
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.
PubMed 18487069Awh 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.
PubMed 16324792Baunez 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.
PubMed 22013416Filoteo 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.
PubMed 9260443Gabrieli, 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. doi: 10.1017/S1355617704104141.
PubMed 15327739Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. doi: 10.1038/35058500.
PubMed 11256080Jahanshahi 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.
PubMed 10825353Kim 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.
PubMed 26090080Klepac 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.
PubMed 18217883Lord 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.
PubMed 19896382Middleton 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.
PubMed 10744919Mimura 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.
PubMed 16563850Nakano 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.
PubMed 11081799Rafal 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.
PubMed 6509309
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Cognition in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02975193
- Acronym / sponsor ID
- IRB201601780
- Conditions
- Parkinson Disease
- Keywords
- Parkinsons Disease, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Computer task assessing cognition, Behavioral: Impulsive-Compulsive Disorders in Parkinson's DiseaseHealthy 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 |
| Parkinson's disease group with DBS | Active comparator | Behavioral: Computer task assessing cognition, Behavioral: Impulsive-Compulsive Disorders in Parkinson's Disease, Procedure: Deep Brain Stimulation SurgeryParkinson'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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer task assessing cognitionParticipants will complete a short computer game to assess cognition. | Behavioural | Control group, Parkinson's disease group with DBS |
| Impulsive-Compulsive Disorders in Parkinson's DiseaseAlso: QUIP-RSStandard clinical questionnaire | Behavioural | Control group, Parkinson's disease group with DBS |
| Deep Brain Stimulation SurgeryDBS surgery for the implantation of electrodes for the treatment of motor disorders. | Procedure or surgery | Parkinson's disease group with DBS |
Primary outcome
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.
2 secondary outcomes
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
Local field potential brain signal
Time frame: At time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 18487069Allcock 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.
- Background: PubMed 16324792Awh 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.
- Background: PubMed 22013416Baunez 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.
- Background: PubMed 9260443Filoteo 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.
- BackgroundGabrieli, 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: PubMed 15327739Henry 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.
- Background: PubMed 11256080Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. doi: 10.1038/35058500.
- Background: PubMed 10825353Jahanshahi 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.
- Background: PubMed 26090080Kim 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.
- Background: PubMed 18217883Klepac 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.
- Background: PubMed 19896382Lord 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.
- Background: PubMed 10744919Middleton 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.
- Individual participant dataSharing planned: Yes. IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysegul Gunduz, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease and Deep Brain Stimulation Surgery in people with Parkinson Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in behavioral performance (time frame: Baseline, before surgery, during surgery, and up to 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975193, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.