Cognitive Training in Parkinson Study

NCT02920632 | Completed Results

• 1 other identifier: CWO/16-10
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Impaired Cognition; Alteration in Cognition

Keywords

Parkinson; Cognitive training; Cognitive rehabilitation; Brain networks

Outcome Measures

Primary Outcomes (1)

• 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")

Secondary Outcomes (11)

• 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)

Other Outcomes (30)

• 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)

Study Arms (3)

Online cognitive training 1

EXPERIMENTAL

Eight-week, three times a week during 45 minutes cognitive training

Behavioral: Online cognitive training 1

Online cognitive training 2

ACTIVE COMPARATOR

Eight-week, three times a week during 45 minutes cognitive activities

Behavioral: Online cognitive training 2

Healthy control subjects

NO INTERVENTION

Reference group to compare cognitive training effects to

Interventions

Online cognitive training 1 BEHAVIORAL

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.

Online cognitive training 1

Online cognitive training 2 BEHAVIORAL

Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.

Online cognitive training 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective cognitive complaints, measured by the Parkinson's Disease Cognitive Functional Rating Scale score \> 3 (PD-CFRS). A score above 3 indicates significant cognitive complaints, that are milder than complaints associated with Parkinson's disease dementia. This questionnaire is filled in by the patient.
• Participants' Hoehn \& Yahr stage is lower than 4. Patients are stable on dopaminergic medication at least a month before starting the intervention. During the intervention, patient and neurologist will be asked to keep the dopaminergic medication dosage as stable as possible.
• Participants have access to a computer or tablet, with access to the Internet. If the participant uses a computer, he or she is capable of using a keyboard and computer mouse.
• Participants are willing to sign informed consent.

You may not qualify if:

• General criteria:
• Indications for a dementia syndrome, measured by the Self-administered Gerocognitive Examination score \< 14 or the Montreal Cognitive Assessment score \< 22.
• Current drug- or alcohol abuse, measured by a score \> 1 on the four CAGE AID-questions (according to the Trimbos guidelines).
• The inability to undergo extensive neuropsychological assessment, or eight weeks of intervention.
• Moderate to severe depressive symptoms, as defined by the Beck Depression Inventory score \> 18.
• An impulse control disorder, including internet addiction, screened by the impulse control disorder criteria interview.
• Psychotic symptoms, screened by the Questionnaire for Psychotic Experiences. Benign hallucinations with insight are not contraindicated.
• Traumatic brain injury, only in case of a contusio cerebri with 1) loss of consciousness for \> 15 minutes and 2) posttraumatic amnesia \> 1 hour.
• A space occupying lesion defined by a radiologist, or significant vascular abnormalities (Fazekas \> 1).
• For participation in MRI research:
• Severe claustrophobia
• Metal in the body (for example, deep brain stimulator or pacemaker)
• Pregnancy
• Problems with or shortness of breath during 60 minutes of lying still.
• Healthy control subjects ---

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dutch Parkinson Patient Association: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Location

Related Publications (20)

• 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.

  PMID: 21661055 BACKGROUND

• 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.

  PMID: 15480840 BACKGROUND

• 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.

  PMID: 16247051 BACKGROUND

• 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.

  PMID: 12633150 BACKGROUND

• 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.

  PMID: 18307261 BACKGROUND

• 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.

  PMID: 19733364 BACKGROUND

• 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: 18217883 BACKGROUND

• 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.

  PMID: 21440699 BACKGROUND

• 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.

  PMID: 20838046 BACKGROUND

• 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.

  PMID: 23985135 BACKGROUND

• 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.

  PMID: 20826433 BACKGROUND

• 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.

  PMID: 22365555 BACKGROUND

• 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.

  PMID: 24867353 BACKGROUND

• 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.

  PMID: 21427462 BACKGROUND

• 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.

  PMID: 21971474 BACKGROUND

• 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.

  PMID: 24639411 BACKGROUND

• 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.

  PMID: 25534579 BACKGROUND

• 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.

  PMID: 26519540 BACKGROUND

• 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.

  PMID: 23426759 BACKGROUND

• 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.

  PMID: 31366395 DERIVED

Related Links

• COGTIPS methodology article
• COGTIPS primary endpoint preprint/publication
• COGTIPS DWI results article

MeSH Terms

Conditions

Parkinson Disease; Cognition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Chris Vriend
• Organization: Amsterdam UMC, Vrije Universiteit

c.vriend@amsterdamumc.nl

+31625694912

Study Officials

• Chris Vriend, PhD.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Odile A Van den Heuvel, MD PhD.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Postdoctoral Researcher

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 30, 2016
• Study Start: September 15, 2017
• Primary Completion: July 17, 2019
• Study Completion: August 9, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)