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| Name | Class |
|---|---|
| Dutch Parkinson Patient Association | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online cognitive training 1 | Experimental | Eight-week, three times a week during 45 minutes cognitive training |
|
| Online cognitive training 2 | Active Comparator | Eight-week, three times a week during 45 minutes cognitive activities |
|
| Healthy control subjects | No Intervention | Reference group to compare cognitive training effects to |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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") |
| Measure | Description | Time Frame |
|---|---|---|
| Total Score on Parkinson's Disease Cognitive Functional Rating Scale | Score on subjective cognitive complaints after eight weeks of cognitive training, measured with the Parkinson's disease Cognitive Functional Rating Scale (PD-CFRS), with score range [0-24], where higher scores indicate more severe subjective cognitive complaints. | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Parkinson's Disease Patients' Brain Network Topology With or Without Cognitive Impairment, and Healthy Control Subjects. | Participants will be classified to cognitive impairment or no cognitive impairment, and their brain network topology will be compared with healthy subjects. | Pre-intervention (T0) |
--- Parkinson's disease patients ---
Inclusion Criteria:
Exclusion Criteria:
General criteria:
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.
Inclusion criteria:
- Participants are willing to sign informed consent.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Vriend, PhD. | Amsterdam UMC, location VUmc | Principal Investigator |
| Odile A Van den Heuvel, MD PhD. | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Amsterdam | North Holland | 1081HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21661055 | Background | 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. | |
| 15480840 | Background |
| Label | URL |
|---|---|
| COGTIPS methodology article | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Online Cognitive Training 1 (N=68) | Eight-week, three times a week during 45 minutes cognitive training 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. |
| FG001 | Online Cognitive Training 2 (N=68) | Eight-week, three times a week during 45 minutes cognitive activities Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. |
| FG002 | Healthy Control Subjects (N=31) | Reference group to compare cognitive training effects to |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two healthy control subjects started participation but withdrew during MRI scanning due to in-scanner panic attacks.
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| ID | Title | Description |
|---|---|---|
| BG000 | Online Cognitive Training 1 (N=68) | Eight-week, three times a week during 45 minutes cognitive training 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Number analyzed lower due to difficulty understanding the task, or no follow-up assessment in PD group and difficulty understanding the task (n=1) in healthy control group. Healthy control subjects did not undergo an intervention and T1 measurement and scores at T1 are therefore not supplied for this subgroup. | Posted | Mean | Standard Deviation | percentage of correct responses | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
|
2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training.
Adverse events were logged.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Online Cognitive Training 1 (N=68) | Eight-week, three times a week during 45 minutes cognitive training 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impulse control disorder | Psychiatric disorders | Non-systematic Assessment | Development of punding during the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical issue related to PD | Nervous system disorders | Non-systematic Assessment | Medical symptoms related to PD |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chris Vriend | Amsterdam UMC, Vrije Universiteit | +31625694912 | c.vriend@amsterdamumc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2020 | Jun 9, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Online cognitive training 2 | Behavioral | Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. |
|
| Total Score on Cognitive Failures Questionnaire | Score on subjective cognitive complaints after eight weeks of cognitive training (T0 to T1), measured by the Cognitive failures questionnaire (CFQ), a questionnaire with range [0-100] where a higher score indicates more severe subjective cognitive complaints. | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
| Reaction Time on the Tower of London Task | Change on Executive function from T0 to T1, measured with the average reaction time on the Tower of London task over all trials. Reaction time is measured in seconds, where higher reaction time is considered worse. | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
| Performance on the Controlled Oral Word Association Test | Executive functions CHANGE after eight weeks of cognitive training (T0 to T1), measured with the Controlled Oral Word Association Test (Letter fluency). Minimum score: 0, there is no maximum score. A higher score indicates better performance. | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
| Performance on Tower of London Accuracy at Six-months Follow-up | Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task six-month after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function. | Six months after training completion (T2) |
| Performance on Tower of London Accuracy at One-year Follow-up | Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task one year after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function. | One year after completion of intervention (T3, "Follow-up 2") |
| Performance on Tower of London Accuracy at Two-year Follow-up | Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task two year after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function. | Two years after completion of the intervention (T4) |
| Conversion to Mild Cognitive Impairment or Dementia at One-year Follow-up | Incidence of conversion of cognitive status at one-year follow-up with respect to the cognitive status at baseline (T0). Cognitive status is defined as cognitively normal (NC), mild cognitive impairment (MCI, according to cognitive aspects of level II MDS criteria), or dementia (according to cognitive aspects of MDS criteria for probable PD dementia). Conversion was defined as -1: conversion to a worse classification (ie, NC to MCI, NC to dementia or MCI to dementia), 0: no change, or 1: conversion to a better classification (ie, dementia to NC, MCI to NC, dementia to MCI). | One year after completion of the intervention (T3) |
| Performance on the Stroop Color-Word Test, Card I | Processing speed change after eight weeks of cognitive training, measured with the Stroop Color Word Test (word-reading), where a higher time to completion indicates worse cognitive function. | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
| Performance on the Stroop Color-Word Test, Card III | Executive function CHANGE after eight weeks of cognitive training, measured with the Stroop Color Word Test (card III, color-word interference), where a higher time to completion indicates worse cognitive function. | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
| Conversion of Cognitive Status at Two-year Follow-up | Count of conversion of cognitive status at two-year follow-up with respect to the cognitive status at baseline (T0). Cognitive status is defined as cognitively normal (NC), mild cognitive impairment (MCI, according to cognitive aspects of level II MDS criteria), or dementia (according to cognitive aspects of MDS criteria for probable PD dementia). Conversion was defined as -1: conversion to a worse classification (ie, NC to MCI, NC to dementia or MCI to dementia), 0: no change, or 1: conversion to a better classification (ie, dementia to NC, MCI to NC, dementia to MCI). | Two year after completion of the intervention (T3) |
| Online Cognitive Training Effect on Brain Network Topology Relative to Healthy Control Group |
The effect of online cognitive training on brain network topology using resting state fMRI compared with brain network topology of healthy subjects. Healthy subjects will undergo (functional) MRI scanning once. |
| Eight weeks (T1) |
| Online Cognitive Training Effect on Brain Activity Measured by Resting State fMRI | The effect of online cognitive training on brain activity using resting state fMRI. Regional activity and functional connectivity changes will be assessed after eight weeks of training (T1). | Eight weeks (T1) |
| Online Cognitive Training Effect on Structural Brain Connectivity Measured by DTI | The effect of online cognitive training on structural brain connectivity using DTI. Structural changes will be assessed after eight weeks of training (T1). | Eight weeks (T1) |
| Online Cognitive Training Effect on Brain Morphology Measured by MRI | The effect of online cognitive training on brain morphology using MRI. Structural changes will be assessed after eight weeks of training (T1). | Eight weeks (T1) |
| Age | Demographic characteristic: age at baseline. | Pre-intervention (T0) |
| Sex | Demographic characteristic: sex. | Pre-intervention (T0) |
| Educational Level | Demographic characteristic: educational level. | Pre-intervention (T0) |
| Disease Duration | Disease characteristic: disease duration. | Pre-intervention (T0) |
| Disease Stage | Disease characteristic: disease stage (Hoehn and Yahr stage). | Pre-intervention (T0), one year (T3), two years (T4) |
| Medication Use | Disease characteristic: medication use. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Motor Symptoms | Motor symptoms assessed by the Unified Parkinson's Disease Rating Scale - III | Pre-intervention (T0), one year (T3), two years (T4) |
| Depressive Symptom Severity | Psychiatric symptom severity, depression (Beck Depression Inventory). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Anxiety Symptom Severity | Psychiatric symptom severity, including anxiety (Parkinson Anxiety Scale). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Impulse Control Disorder Symptom Severity | Psychiatric symptom severity, including impulse control disorders (QUIP-RS). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Psychotic Symptom Severity | Psychiatric symptom severity, including psychotic symptoms (Questionnaire for psychotic events). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Apathy Symptom Severity | Psychiatric symptom severity, including apathy (Apathy Scale). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Expectations of the Intervention | Participants' expectation prior the intervention, measured by the credibility/expectancy questionnaire. | Pre-intervention (T0) |
| Global Cognitive Functioning (1) | Global cognitive functioning assessed by the Montreal Cognitive Assessment (MoCA). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Global Cognitive Functioning (2) | Global cognitive functioning assessed by the Pentagon copy test, which is predictive of cognitive deterioration. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Attention/Working Memory (1) | Attention function, measured by the Stroop task part I: word naming. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Attention/Working Memory (2) | Working memory function, measured by the backwards digit span test of the Wechsler adult intelligence test (WAIS)-III. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Episodic Memory (1) | Episodic memory function, measured by the Dutch version of the Auditory verbal learning test (RAVLT). | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Episodic Memory (2) | Episodic memory function, measured by the Location learning task. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Language (1) | Language function, measured by the Boston naming task. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Language (2) | Language function, measured by the category fluency task. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Visuospatial/Visuoconstructive Function (1) | Visuospatial function, measured by the Benton visual form discrimination task. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Specific Cognitive Functioning: Visuospatial/Visuoconstructive Function (2) | Visuospatial function, measured by the Rey complex figure task. | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Physical Activity | Amount of estimated physical activity that a person performs, measured by the New Zealand Physical Activity Questionnaire | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) |
| Cognitive Reserve | Estimation of cognitive reserve measured with the Cognitive Reserve Index questionnaire | Two years (T4) |
| 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. |
| 16247051 | 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. |
| 12633150 | 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. |
| 18307261 | 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. |
| 19733364 | 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. |
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| 21440699 | 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. |
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| 24867353 | 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. |
| 21427462 | 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. |
| 21971474 | 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. |
| 24639411 | 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. |
| 25534579 | 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. |
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| 23426759 | 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. |
| 31366395 | Derived | 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. |
| COGTIPS DWI results article | View source |
| Online Cognitive Training 2 (N=68) |
Eight-week, three times a week during 45 minutes cognitive activities Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. |
| BG002 | Healthy Control Subjects (N=31) | Reference group to compare cognitive training effects to |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Unified PD Rating Scale-III - motor score (UPDRS-III) | UPDRS-III motor score measures severity of PD motor symptoms on a continuous scale (range 0-108, higher is considered worse) | UPDRS-III not taken in healthy controls (disease-specific measure) | Mean | Standard Deviation | units on the motor score scale |
|
| Montreal Cognitive Assessment (MoCA) | MoCA measures global cognitive function on a continuous scale (range 0-30, higher is considered better) | Mean | Standard Deviation | units on the MoCA scale |
|
| Beck Depression Inventory (BDI) | BDI measures severity of depressive symptoms on a continuous scale (range 0-63, higher is considered worse) | Mean | Standard Deviation | units on the BDI scale |
|
| OG001 | Online Cognitive Training 2 | Eight-week, three times a week during 45 minutes cognitive activities Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. |
| OG002 | Healthy Control Subjects | Reference group to compare cognitive training effects to |
|
|
| Secondary | Total Score on Parkinson's Disease Cognitive Functional Rating Scale | Score on subjective cognitive complaints after eight weeks of cognitive training, measured with the Parkinson's disease Cognitive Functional Rating Scale (PD-CFRS), with score range [0-24], where higher scores indicate more severe subjective cognitive complaints. | Questionnaire not taken in healthy control group | Posted | Mean | Standard Deviation | score on a scale | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
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| Secondary | Total Score on Cognitive Failures Questionnaire | Score on subjective cognitive complaints after eight weeks of cognitive training (T0 to T1), measured by the Cognitive failures questionnaire (CFQ), a questionnaire with range [0-100] where a higher score indicates more severe subjective cognitive complaints. | One participant in Online cognitive training 1 did not fill out the questionnaires. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
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| Secondary | Reaction Time on the Tower of London Task | Change on Executive function from T0 to T1, measured with the average reaction time on the Tower of London task over all trials. Reaction time is measured in seconds, where higher reaction time is considered worse. | Number analyzed lower due to difficulty understanding the task (n=7), or no follow-up assessment (n=3) in PD group and difficulty understanding the task (n=1) in healthy control group. Healthy control subjects did not undergo an intervention and T1 measurement and scores at post-intervention are therefore not supplied. | Posted | Mean | Standard Deviation | seconds | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
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| Secondary | Performance on the Controlled Oral Word Association Test | Executive functions CHANGE after eight weeks of cognitive training (T0 to T1), measured with the Controlled Oral Word Association Test (Letter fluency). Minimum score: 0, there is no maximum score. A higher score indicates better performance. | Three participants dropped out of the study and did not perform the T1 measurement and were subsequently removed from analyses. Healthy control subjects did not perform the second assessment. | Posted | Mean | Standard Deviation | total number of words produced | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
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| Secondary | Performance on Tower of London Accuracy at Six-months Follow-up | Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task six-month after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function. | Healthy control subjects did not undergo follow-up assessment. Number of participants analyzed lower than total population due to drop-out at T2 (n=8) and difficulty understanding the task at one of the time-points (n=11) | Posted | Mean | Standard Deviation | percentage of correct responses | Six months after training completion (T2) |
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| Secondary | Performance on Tower of London Accuracy at One-year Follow-up | Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task one year after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function. | Healthy control subjects did not undergo follow-up assessments. Number of participants analyzed differs from total sample due to drop-out (n=12), missed assessment (n=15) and difficulty understanding the task (n=2). | Posted | Mean | Standard Deviation | percentage of correct responses | One year after completion of intervention (T3, "Follow-up 2") |
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| Secondary | Performance on Tower of London Accuracy at Two-year Follow-up | Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task two year after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function. | Healthy control subjects did not undergo follow-up assessemnts. Number of participants analyzed differs from total sample due to drop-out (n=12), missed assessment (n=21) and difficulty understanding the task. | Posted | Mean | Standard Deviation | percentage of correct responses | Two years after completion of the intervention (T4) |
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| Secondary | Conversion to Mild Cognitive Impairment or Dementia at One-year Follow-up | Incidence of conversion of cognitive status at one-year follow-up with respect to the cognitive status at baseline (T0). Cognitive status is defined as cognitively normal (NC), mild cognitive impairment (MCI, according to cognitive aspects of level II MDS criteria), or dementia (according to cognitive aspects of MDS criteria for probable PD dementia). Conversion was defined as -1: conversion to a worse classification (ie, NC to MCI, NC to dementia or MCI to dementia), 0: no change, or 1: conversion to a better classification (ie, dementia to NC, MCI to NC, dementia to MCI). | Healthy control subjects did not undergo follow-up assessments. Number of participants analyzed differs from total population due to drop-out and missed assessment. | Posted | Number | participants | One year after completion of the intervention (T3) |
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| Secondary | Performance on the Stroop Color-Word Test, Card I | Processing speed change after eight weeks of cognitive training, measured with the Stroop Color Word Test (word-reading), where a higher time to completion indicates worse cognitive function. | Three participants dropped out of the study and did not perform the T1 measurement and were subsequently removed from analyses. Healthy control subjects did not perform the second assessment. | Posted | Mean | Standard Deviation | time in seconds | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
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| Secondary | Performance on the Stroop Color-Word Test, Card III | Executive function CHANGE after eight weeks of cognitive training, measured with the Stroop Color Word Test (card III, color-word interference), where a higher time to completion indicates worse cognitive function. | Three participants dropped out of the study and did not perform the T1 measurement and one participant did not undergo card III of the Stroop color word test at T1; these participants were subsequently removed from analyses. Healthy control subjects did not perform the second assessment. | Posted | Mean | Standard Deviation | time in seconds | Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention") |
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| Secondary | Conversion of Cognitive Status at Two-year Follow-up | Count of conversion of cognitive status at two-year follow-up with respect to the cognitive status at baseline (T0). Cognitive status is defined as cognitively normal (NC), mild cognitive impairment (MCI, according to cognitive aspects of level II MDS criteria), or dementia (according to cognitive aspects of MDS criteria for probable PD dementia). Conversion was defined as -1: conversion to a worse classification (ie, NC to MCI, NC to dementia or MCI to dementia), 0: no change, or 1: conversion to a better classification (ie, dementia to NC, MCI to NC, dementia to MCI). | Healthy control subjects did not undergo follow-up assessments. Number of participants analyzed differs from total population due to drop-out and missed assessment. | Posted | Number | participants | Two year after completion of the intervention (T3) |
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| Other Pre-specified | Difference Between Parkinson's Disease Patients' Brain Network Topology With or Without Cognitive Impairment, and Healthy Control Subjects. | Participants will be classified to cognitive impairment or no cognitive impairment, and their brain network topology will be compared with healthy subjects. | Not Posted | Pre-intervention (T0) | Participants |
| Other Pre-specified | Online Cognitive Training Effect on Brain Network Topology Relative to Healthy Control Group | The effect of online cognitive training on brain network topology using resting state fMRI compared with brain network topology of healthy subjects. Healthy subjects will undergo (functional) MRI scanning once. | Not Posted | Eight weeks (T1) | Participants |
| Other Pre-specified | Online Cognitive Training Effect on Brain Activity Measured by Resting State fMRI | The effect of online cognitive training on brain activity using resting state fMRI. Regional activity and functional connectivity changes will be assessed after eight weeks of training (T1). | Not Posted | Eight weeks (T1) | Participants |
| Other Pre-specified | Online Cognitive Training Effect on Structural Brain Connectivity Measured by DTI | The effect of online cognitive training on structural brain connectivity using DTI. Structural changes will be assessed after eight weeks of training (T1). | Not Posted | Eight weeks (T1) | Participants |
| Other Pre-specified | Online Cognitive Training Effect on Brain Morphology Measured by MRI | The effect of online cognitive training on brain morphology using MRI. Structural changes will be assessed after eight weeks of training (T1). | Not Posted | Eight weeks (T1) | Participants |
| Other Pre-specified | Age | Demographic characteristic: age at baseline. | Not Posted | Pre-intervention (T0) | Participants |
| Other Pre-specified | Sex | Demographic characteristic: sex. | Not Posted | Pre-intervention (T0) | Participants |
| Other Pre-specified | Educational Level | Demographic characteristic: educational level. | Not Posted | Pre-intervention (T0) | Participants |
| Other Pre-specified | Disease Duration | Disease characteristic: disease duration. | Not Posted | Pre-intervention (T0) | Participants |
| Other Pre-specified | Disease Stage | Disease characteristic: disease stage (Hoehn and Yahr stage). | Not Posted | Pre-intervention (T0), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Medication Use | Disease characteristic: medication use. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Motor Symptoms | Motor symptoms assessed by the Unified Parkinson's Disease Rating Scale - III | Not Posted | Pre-intervention (T0), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Depressive Symptom Severity | Psychiatric symptom severity, depression (Beck Depression Inventory). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Anxiety Symptom Severity | Psychiatric symptom severity, including anxiety (Parkinson Anxiety Scale). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Impulse Control Disorder Symptom Severity | Psychiatric symptom severity, including impulse control disorders (QUIP-RS). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Psychotic Symptom Severity | Psychiatric symptom severity, including psychotic symptoms (Questionnaire for psychotic events). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Apathy Symptom Severity | Psychiatric symptom severity, including apathy (Apathy Scale). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Expectations of the Intervention | Participants' expectation prior the intervention, measured by the credibility/expectancy questionnaire. | Not Posted | Pre-intervention (T0) | Participants |
| Other Pre-specified | Global Cognitive Functioning (1) | Global cognitive functioning assessed by the Montreal Cognitive Assessment (MoCA). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Global Cognitive Functioning (2) | Global cognitive functioning assessed by the Pentagon copy test, which is predictive of cognitive deterioration. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Attention/Working Memory (1) | Attention function, measured by the Stroop task part I: word naming. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Attention/Working Memory (2) | Working memory function, measured by the backwards digit span test of the Wechsler adult intelligence test (WAIS)-III. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Episodic Memory (1) | Episodic memory function, measured by the Dutch version of the Auditory verbal learning test (RAVLT). | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Episodic Memory (2) | Episodic memory function, measured by the Location learning task. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Language (1) | Language function, measured by the Boston naming task. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Language (2) | Language function, measured by the category fluency task. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Visuospatial/Visuoconstructive Function (1) | Visuospatial function, measured by the Benton visual form discrimination task. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Specific Cognitive Functioning: Visuospatial/Visuoconstructive Function (2) | Visuospatial function, measured by the Rey complex figure task. | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Physical Activity | Amount of estimated physical activity that a person performs, measured by the New Zealand Physical Activity Questionnaire | Not Posted | Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) | Participants |
| Other Pre-specified | Cognitive Reserve | Estimation of cognitive reserve measured with the Cognitive Reserve Index questionnaire | Not Posted | Two years (T4) | Participants |
| 0 |
| 68 |
| 0 |
| 68 |
| 9 |
| 68 |
| EG001 | Online Cognitive Training 2 (N=68) | Eight-week, three times a week during 45 minutes cognitive activities Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. | 0 | 68 | 1 | 68 | 10 | 68 |
| EG002 | Healthy Control Subjects (N=31) | Reference group to compare cognitive training effects to | 0 | 31 | 0 | 31 | 0 | 31 |
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| Training-related adverse event | General disorders | Non-systematic Assessment | Stress due to intervention |
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| Medical issue not PD-related: COVID | Infections and infestations | Non-systematic Assessment | COVID infection |
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| Medical issue other than PD: Ear infection | Infections and infestations | Non-systematic Assessment | Ear infection |
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| Medical issue other than PD: injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Injury due to accident |
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| Medical issue other than PD: meningioma | Nervous system disorders | Non-systematic Assessment | Complications due to meningioma |
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| Medical issue other than PD: cerebral infarction | Nervous system disorders | Non-systematic Assessment | Cerebral infarction |
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| Medical issue other than PD: Restless legs and hyperventilation | General disorders | Non-systematic Assessment | Restless legs and hyperventilation |
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| Medical issue other than PD: dizziness | General disorders | Non-systematic Assessment | Dizziness |
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Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Male |
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| Eight weeks - T1 |
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| Eight weeks (T1) |
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| 1: Conversion to better classification |
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| Eight weeks (T1) |
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| Eight weeks (T1) |
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| 1: Conversion to better classification |
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