NCT02920632|CompletedResults
Cognitive Training in Parkinson Study
cogtips
COGTIPS (COGnitive Training In Parkinson Study): The Effect of Online Cognitive Training on Cognition and Brain Networks in Parkinson's Disease
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Sponsor study identifier
interventional
167
1 country
1
Study Start
September 15, 2017
Actual (reported)Primary Completion
July 17, 2019
Actual (reported)Study Completion
August 9, 2021
Actual (reported)This study evaluates the efficacy of an eight-week online cognitive training program on objective and subjective cognitive functions in Parkinson's disease. Moreover, we intend to map the effect on brain network function, and if cognitive training can prevent the development of PD-MCI/PD-D after one- and two-year follow-up. In this study, two training groups will be compared (N: 70 vs 70). In a part of the participants MRI will be assessed (N: 40 vs. 40). We expect cognitive training to improve cognitive functions, and to improve the efficiency of brain network function. Moreover, we expect that cognitive training can decrease the risk of PD-MCI/PD-D at one- and two-year follow-up.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2016
Actual (reported)September 30, 2016
Actual (reported)September 15, 2017
Actual (reported)July 17, 2019
Actual (reported)August 9, 2021
Actual (reported)September 19, 2024
Actual (reported)Accuracy on the Tower of London Task
Change in executive function after eight weeks of cognitive training as measured by percentage correct on the Tower of London task. Accuracy is measured in percentage correct (%, range 0-100, higher is considered better).
Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")
Total Score on Parkinson's Disease Cognitive Functional Rating Scale
Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")
Total Score on Cognitive Failures Questionnaire
Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")
Reaction Time on the Tower of London Task
Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")
Performance on the Controlled Oral Word Association Test
Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")
Performance on Tower of London Accuracy at Six-months Follow-up
Six months after training completion (T2)
Difference Between Parkinson's Disease Patients' Brain Network Topology With or Without Cognitive Impairment, and Healthy Control Subjects.
Pre-intervention (T0)
Online Cognitive Training Effect on Brain Network Topology Relative to Healthy Control Group
Eight weeks (T1)
Online Cognitive Training Effect on Brain Activity Measured by Resting State fMRI
Eight weeks (T1)
Eight-week, three times a week during 45 minutes cognitive training
Eight-week, three times a week during 45 minutes cognitive activities
Reference group to compare cognitive training effects to
Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
VU University Medical Center
Amsterdam, North Holland, 1081HV, Netherlands
Litvan I, Aarsland D, Adler CH, Goldman JG, Kulisevsky J, Mollenhauer B, Rodriguez-Oroz MC, Troster AI, Weintraub D. MDS Task Force on mild cognitive impairment in Parkinson's disease: critical review of PD-MCI. Mov Disord. 2011 Aug 15;26(10):1814-24. doi: 10.1002/mds.23823. Epub 2011 Jun 9.
Bosboom JL, Stoffers D, Wolters ECh. Cognitive dysfunction and dementia in Parkinson's disease. J Neural Transm (Vienna). 2004 Oct;111(10-11):1303-15. doi: 10.1007/s00702-004-0168-1. Epub 2004 Jun 30.
Sample size fell short of the intended statistical power: the initial sample size calculation was based on a within-between interaction of a repeated-measures ANOVA (corrected for pre-post assessment correlation r=.6) based on an effect size f=0.12 of CT on global cognitive function (Leung et al 2015). After trial completion we discovered this sample size is insufficient to detect the expected effect on global cognition due to obscurity in effect size parameter definition in G\*Power.
Chris Vriend, PhD.
Amsterdam UMC, location VUmc
Odile A Van den Heuvel, MD PhD.
Amsterdam UMC, location VUmc
167 participants (actual enrollment reported by the registry).
First Submitted
August 30, 2016
First Posted
September 30, 2016
Study Start
September 15, 2017
Actual (reported)On-line Cognitive Training for Parkinson's Disease
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Muslimovic D, Post B, Speelman JD, Schmand B. Cognitive profile of patients with newly diagnosed Parkinson disease. Neurology. 2005 Oct 25;65(8):1239-45. doi: 10.1212/01.wnl.0000180516.69442.95.
Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sorensen P. Prevalence and characteristics of dementia in Parkinson disease: an 8-year prospective study. Arch Neurol. 2003 Mar;60(3):387-92. doi: 10.1001/archneur.60.3.387.
Hely MA, Reid WG, Adena MA, Halliday GM, Morris JG. The Sydney multicenter study of Parkinson's disease: the inevitability of dementia at 20 years. Mov Disord. 2008 Apr 30;23(6):837-44. doi: 10.1002/mds.21956.
Aarsland D, Kurz MW. The epidemiology of dementia associated with Parkinson disease. J Neurol Sci. 2010 Feb 15;289(1-2):18-22. doi: 10.1016/j.jns.2009.08.034. Epub 2009 Sep 4.
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.
Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
Olazaran J, Reisberg B, Clare L, Cruz I, Pena-Casanova J, Del Ser T, Woods B, Beck C, Auer S, Lai C, Spector A, Fazio S, Bond J, Kivipelto M, Brodaty H, Rojo JM, Collins H, Teri L, Mittelman M, Orrell M, Feldman HH, Muniz R. Nonpharmacological therapies in Alzheimer's disease: a systematic review of efficacy. Dement Geriatr Cogn Disord. 2010;30(2):161-78. doi: 10.1159/000316119. Epub 2010 Sep 10.
Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.
Castellanos NP, Paul N, Ordonez VE, Demuynck O, Bajo R, Campo P, Bilbao A, Ortiz T, del-Pozo F, Maestu F. Reorganization of functional connectivity as a correlate of cognitive recovery in acquired brain injury. Brain. 2010 Aug;133(Pt 8):2365-81. doi: 10.1093/brain/awq174.
Subramaniam K, Luks TL, Fisher M, Simpson GV, Nagarajan S, Vinogradov S. Computerized cognitive training restores neural activity within the reality monitoring network in schizophrenia. Neuron. 2012 Feb 23;73(4):842-53. doi: 10.1016/j.neuron.2011.12.024.
Subramaniam K, Luks TL, Garrett C, Chung C, Fisher M, Nagarajan S, Vinogradov S. Intensive cognitive training in schizophrenia enhances working memory and associated prefrontal cortical efficiency in a manner that drives long-term functional gains. Neuroimage. 2014 Oct 1;99:281-92. doi: 10.1016/j.neuroimage.2014.05.057. Epub 2014 May 24.
Belleville S, Clement F, Mellah S, Gilbert B, Fontaine F, Gauthier S. Training-related brain plasticity in subjects at risk of developing Alzheimer's disease. Brain. 2011 Jun;134(Pt 6):1623-34. doi: 10.1093/brain/awr037. Epub 2011 Mar 22.
Rosen AC, Sugiura L, Kramer JH, Whitfield-Gabrieli S, Gabrieli JD. Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. J Alzheimers Dis. 2011;26 Suppl 3(Suppl 3):349-57. doi: 10.3233/JAD-2011-0009.
Baggio HC, Sala-Llonch R, Segura B, Marti MJ, Valldeoriola F, Compta Y, Tolosa E, Junque C. Functional brain networks and cognitive deficits in Parkinson's disease. Hum Brain Mapp. 2014 Sep;35(9):4620-34. doi: 10.1002/hbm.22499. Epub 2014 Mar 17.
Petrelli A, Kaesberg S, Barbe MT, Timmermann L, Rosen JB, Fink GR, Kessler J, Kalbe E. Cognitive training in Parkinson's disease reduces cognitive decline in the long term. Eur J Neurol. 2015 Apr;22(4):640-7. doi: 10.1111/ene.12621. Epub 2014 Dec 22.
Leung IH, Walton CC, Hallock H, Lewis SJ, Valenzuela M, Lampit A. Cognitive training in Parkinson disease: A systematic review and meta-analysis. Neurology. 2015 Nov 24;85(21):1843-51. doi: 10.1212/WNL.0000000000002145. Epub 2015 Oct 30.
Hindle JV, Petrelli A, Clare L, Kalbe E. Nonpharmacological enhancement of cognitive function in Parkinson's disease: a systematic review. Mov Disord. 2013 Jul;28(8):1034-49. doi: 10.1002/mds.25377. Epub 2013 Feb 20.
van Balkom TD, Berendse HW, van der Werf YD, Twisk JWR, Zijlstra I, Hagen RH, Berk T, Vriend C, van den Heuvel OA. COGTIPS: a double-blind randomized active controlled trial protocol to study the effect of home-based, online cognitive training on cognition and brain networks in Parkinson's disease. BMC Neurol. 2019 Jul 31;19(1):179. doi: 10.1186/s12883-019-1403-6.
Primary Completion
July 17, 2019
Actual (reported)Study Completion
August 9, 2021
Actual (reported)Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-05
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