Study Results
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
167 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-15
Study Completion Date
2021-08-09
Brief Summary
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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.
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Detailed Description
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BACKGROUND In Parkinson's disease (PD), cognitive dysfunction is frequently reported - approximately 50% of PD patients experience cognitive impairment (Litvan et al., 2011). Of these impairments, executive dysfunction is most frequently reported early in the disease trajectory (Bosboom, Stoffers, \& Wolters, 2004; Muslimovic, Post, Speelman, \& Schmand, 2005), while impairments in other cognitive domains (i.e. attention, episodic memory, visuospatial functions) are also highly prevalent (Bosboom et al., 2004). The majority of PD patients ultimately develops PD dementia (PD-D; Aarsland, Andersen, Larsen, Lolk, \& Kragh-Sorensen, 2003; Hely, Reid, Adena, Halliday, \& Morris, 2008). Moreover, about 10% of the PD patients develops PD-D every year (Aarsland \& Kurz, 2010). Cognitive dysfunctions in PD have a significant negative influence on the quality of life (Klepac, Trkulja, Relja, \& Babic, 2008), while treatment of these dysfunctions is in its infancy.
Cognitive training may provide a new intervention for reducing cognitive complaints and delaying the onset of mild cognitive impairment (MCI) or PD-D. This intervention has been widely studied in other diseases (Cicerone et al., 2011; Olazaran et al., 2010). Moreover, studies have provided evidence not only for behavioral influences, but also for brain connectivity and activity effects of cognitive training (Chapman et al., 2015; Castellanos et al., 2010; Subramaniam et al., 2012; Subramaniam et al., 2014; Belleville et al., 2011; Rosen, Sugiura, Kramer, Whitfield-Gabrieli, \& Gabrieli, 2011). This suggests a restorative effect of cognitive training on disrupted brain networks.
In PD, cognitive dysfunction - mainly executive dysfunction - is associated with disruption of the cortico-striato-thalamo-corticale circuits by depletion of dopamine. Dysfunction of these circuits seems to disrupt several cognitive networks, which leads to cognitive dysfunction (Baggio et al., 2014). Cognitive training could counteract these disruptions by normalising activity and connectivity, and ultimately lead to a reduction of impairment. Since earlier studies in different patient populations have shown that cognitive training has lasting effects (Petrelli et al., 2015), normalising disruptions underlying cognitive impairment could prevent cognitive deterioration and therefore prevent or delay the development of PD-D.
Few studies in PD have focused on cognitive training and its neural correlates. A meta-analysis by Leung et al. (2015) showed positive effects of cognitive training on mainly 'frontal' cognitive functions (i.e. working memory, executive functions, processing speed). In addition, earlier research has described a neuroprotective effect of cognitive training on the development of MCI in PD (odds ratio: 3; Petrelli et al., 2015). Until now, however, studies have been relatively small and mainly without a controlled design - consequently, there is a need for large randomized controlled studies (Hindle, Petrelli, Clare, \& Kalbe, 2013; Leung et al., 2015). Moreover, neural effects of cognitive training are largely unknown in PD. Furthermore, it is important to study the improvement of patients on daily functioning after cognitive training, rather than solely focusing on cognitive tasks and neural measures. Finally, cognitive training has been performed mainly in hospital settings, while PD patients have mobility problems - a training method suitable to perform from home is therefore needed for this population.
OBJECTIVES The study objective is primarily to measure the effect of an online cognitive training in patients with mild cognitive complaints in PD. An online training, specifically altered for PD patients (BrainGymmer) will be compared with an active comparator. In both conditions, participants will train eight weeks, three times a week during 45 minutes.
Primary objective:
\- To measure the effect of an online cognitive training (as compared to the active comparator), eight weeks, three times a week, on executive functions in patients with mild cognitive complaints in PD.
Secondary objectives:
* To measure the effect of online cognitive training on daily functioning.
* To measure the endurance of the training effect after six months, one and two years.
* To assess the reduced risk of MCI and PD-D development by cognitive training.
* To assess the effect of cognitive training on brain network efficiency and connectivity.
* To assess the effect of cognitive training on brain network topology and connectivity, and cognition, relative to those of matched healthy control participants.
* To assess the difference in brain network topology and connectivity, and cognition, between Parkinson's disease patients with or without cognitive impairment and healthy control participants.
Cognitive training may provide a new intervention for reducing cognitive complaints and delaying the onset of mild cognitive impairment (MCI) or PD-D. This intervention has been widely studied in other diseases (Cicerone et al., 2011; Olazaran et al., 2010). Moreover, studies have provided evidence not only for behavioral influences, but also for brain connectivity and activity effects of cognitive training (Chapman et al., 2015; Castellanos et al., 2010; Subramaniam et al., 2012; Subramaniam et al., 2014; Belleville et al., 2011; Rosen, Sugiura, Kramer, Whitfield-Gabrieli, \& Gabrieli, 2011). This suggests a restorative effect of cognitive training on disrupted brain networks.
In PD, cognitive dysfunction - mainly executive dysfunction - is associated with disruption of the cortico-striato-thalamo-corticale circuits by depletion of dopamine. Dysfunction of these circuits seems to disrupt several cognitive networks, which leads to cognitive dysfunction (Baggio et al., 2014). Cognitive training could counteract these disruptions by normalising activity and connectivity, and ultimately lead to a reduction of impairment. Since earlier studies in different patient populations have shown that cognitive training has lasting effects (Petrelli et al., 2015), normalising disruptions underlying cognitive impairment could prevent cognitive deterioration and therefore prevent or delay the development of PD-D.
Few studies in PD have focused on cognitive training and its neural correlates. A meta-analysis by Leung et al. (2015) showed positive effects of cognitive training on mainly 'frontal' cognitive functions (i.e. working memory, executive functions, processing speed). In addition, earlier research has described a neuroprotective effect of cognitive training on the development of MCI in PD (odds ratio: 3; Petrelli et al., 2015). Until now, however, studies have been relatively small and mainly without a controlled design - consequently, there is a need for large randomized controlled studies (Hindle, Petrelli, Clare, \& Kalbe, 2013; Leung et al., 2015). Moreover, neural effects of cognitive training are largely unknown in PD. Furthermore, it is important to study the improvement of patients on daily functioning after cognitive training, rather than solely focusing on cognitive tasks and neural measures. Finally, cognitive training has been performed mainly in hospital settings, while PD patients have mobility problems - a training method suitable to perform from home is therefore needed for this population.
OBJECTIVES The study objective is primarily to measure the effect of an online cognitive training in patients with mild cognitive complaints in PD. An online training, specifically altered for PD patients (BrainGymmer) will be compared with an active comparator. In both conditions, participants will train eight weeks, three times a week during 45 minutes.
Primary objective:
\- To measure the effect of an online cognitive training (as compared to the active comparator), eight weeks, three times a week, on executive functions in patients with mild cognitive complaints in PD.
Secondary objectives:
* To measure the effect of online cognitive training on daily functioning.
* To measure the endurance of the training effect after six months, one and two years.
* To assess the reduced risk of MCI and PD-D development by cognitive training.
* To assess the effect of cognitive training on brain network efficiency and connectivity.
* To assess the effect of cognitive training on brain network topology and connectivity, and cognition, relative to those of matched healthy control participants.
* To assess the difference in brain network topology and connectivity, and cognition, between Parkinson's disease patients with or without cognitive impairment and healthy control participants.
Conditions
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Parkinson Disease
Impaired Cognition
Alteration in Cognition
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Online cognitive training 1
Eight-week, three times a week during 45 minutes cognitive training
Group Type
EXPERIMENTAL
Online cognitive training 1
Intervention Type
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 2
Eight-week, three times a week during 45 minutes cognitive activities
Group Type
ACTIVE_COMPARATOR
Online cognitive training 2
Intervention Type
BEHAVIORAL
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
Healthy control subjects
Reference group to compare cognitive training effects to
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Online cognitive training 1
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.
Intervention Type
BEHAVIORAL
Online cognitive training 2
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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.
\- Participants are willing to sign informed consent.
* 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.
\- Participants are willing to sign informed consent.
Exclusion Criteria
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 ---
* Indications for a neurological disease, such as Parkinson's disease, Alzheimer's disease, mild cognitive impairment, multiple sclerosis or Huntington's disease;
* Indications for a dementia syndrome, measured by the Montreal Cognitive Assessment score \< 22.
* Indications for a current stroke or CVA, or in the past.
* Indications for the presence of a psychotic or depressive disorder, measured with a positive screening on the SAPS-PD (benign hallucinations with insight are not contraindicated) and a BDI \> 18 respectively.
* 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.
* Traumatic brain injury, only in case of a contusio cerebri with 1) loss of conciousness for \> 15 minutes and 2) posttraumatic amnesia \> 1 hour.
* A space occupying lesion defined by a radiologist, or significant vascular abnormalities (Fazekas \> 1).
* Contra-indications for participation in MRI scanning (see above)
* 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 ---
* Indications for a neurological disease, such as Parkinson's disease, Alzheimer's disease, mild cognitive impairment, multiple sclerosis or Huntington's disease;
* Indications for a dementia syndrome, measured by the Montreal Cognitive Assessment score \< 22.
* Indications for a current stroke or CVA, or in the past.
* Indications for the presence of a psychotic or depressive disorder, measured with a positive screening on the SAPS-PD (benign hallucinations with insight are not contraindicated) and a BDI \> 18 respectively.
* 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.
* Traumatic brain injury, only in case of a contusio cerebri with 1) loss of conciousness for \> 15 minutes and 2) posttraumatic amnesia \> 1 hour.
* A space occupying lesion defined by a radiologist, or significant vascular abnormalities (Fazekas \> 1).
* Contra-indications for participation in MRI scanning (see above)
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Dutch Parkinson Patient Association
OTHER
Sponsor Role
collaborator
Amsterdam UMC, location VUmc
OTHER
Sponsor Role
lead
Responsible Party
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Chris Vriend, PhD
Principle Investigator, Postdoctoral Researcher
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Chris Vriend, PhD.
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Odile A Van den Heuvel, MD PhD.
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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VU University Medical Center
Amsterdam, North Holland, Netherlands
Site Status
Countries
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Netherlands
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://doi.org/10.1186/s12883-019-1403-6
COGTIPS methodology article
https://doi.org/10.1101/2021.03.04.21252499
COGTIPS primary endpoint preprint/publication
https://doi.org/10.1007/s13311-021-01103-9
COGTIPS DWI results article
Other Identifiers
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CWO/16-10
Identifier Type: -
Identifier Source: org_study_id
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