- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Florida
-
Gainesville, Florida, Förenta staterna, 32611
- University of Florida
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Control group
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 |
Participants will complete a short computer game to assess cognition.
Standard clinical questionnaire
Andra namn:
|
Aktiv komparator: Parkinson's disease group with DBS
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 |
Participants will complete a short computer game to assess cognition.
Standard clinical questionnaire
Andra namn:
DBS surgery for the implantation of electrodes for the treatment of motor disorders.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in behavioral performance
Tidsram: 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.
|
Baseline, before surgery, during surgery, and up to 2 years after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
Tidsram: 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.
|
Baseline, before surgery, during surgery, and up to 2 years after surgery
|
Local field potential brain signal
Tidsram: 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)
|
At time of surgery
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Aysegul Gunduz, PhD, University of Florida
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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. doi: 10.1017/S1355617704104141.
- Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. doi: 10.1038/35058500.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB201601780
- F30NS111841 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Parkinsons sjukdom
-
Abbott Medical DevicesBaylor College of Medicine; University of HoustonAvslutad
-
Bial - Portela C S.A.Avslutad
-
Mayo ClinicAvslutad
-
Ataturk UniversityRekrytering
-
Centre Hospitalier Universitaire, AmiensOkändParkinson | ImpulskontrollstörningFrankrike
-
University of Sao Paulo General HospitalInCor Heart InstituteAvslutadHjärtarytmier | Tillbehörsväg | Wolf Parkinson White SyndromeBrasilien
-
Assistance Publique - Hôpitaux de ParisCentre Hospitalier Universitaire de Pointe-a-PitreAvslutad
-
Institute for Neurodegenerative DisordersAvslutadParkinson | Parkinsons syndromFörenta staterna
-
University of PlymouthHar inte rekryterat ännu
-
Radboud University Medical CenterAnmälan via inbjudanParkinsons sjukdom | ParkinsonNederländerna