Clinical trial NCT03139799: Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons
Official title: Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Acquired Brain Injury
Cognitive Impairment
Healthy
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a 16-week, assessor blinded, randomized crossover design with two phases of treatment and three waves of measurement. Participants are randomly allocated to either the experimental (group T) or control intervention (group C). Group T will first receive the experimental and then the control intervention (T-C) while group C is given the opposite order of intervention (C-T). In phase I both groups take a baseline measurement (pre-test), then group T is given the casual puzzle game task (experimental intervention) while group C is performing the newspaper reading task (control intervention). After phase I (8 weeks) both groups are post-tested (mid-test). In phase II, groups are switched and the control group C is given the experimental intervention (casual puzzle game task) while the experimental intervention group T now serves as control. After phase II (16 weeks) both groups are post-tested again.
Primary purpose: OTHER

Brief summary: This study aims at investigating the effects of tablet-based puzzle video games on cognitive function and emotional well-being. This study extends preliminary findings of studies looking at short-term benefits of playing puzzle video games to a long-term intervention in healthy older adults and patients suffering from cognitive impairment due to mild cognitive impairment or acquired brain injury. To this end, the investigators compare two interventions: A tablet-based puzzle video games experimental intervention and a control intervention tablet newspaper-reading control intervention. This study uses a 16-week, assessor blinded, randomized crossover design with two phases of treatment and three waves of measurement. Participants are randomly allocated to either the experimental or control intervention for 8 weeks, then interventions are crossed over. Both groups receive both interventions in opposite order. At three time points (pre-, mid- and post-test) higher cognitive function and emotional well-being are tested using standardised neuropsychological tests and questionnaires.

Detailed description: The focus of the current project is to examine the cognitive and emotional benefits of a casual puzzle video game (CPVG) intervention in healthy older adults (HOA), patients suffering from mild cognitive impairment (MCI) and acquired brain injury (ABI). Although there have only been a small number of studies specifically using CPVG interventions, recent studies were able to demonstrate the validity of CPVG in improving attentional and executive function and speed of processing (Oei \& Patterson, 2013; Stroud \& Whitbourne, 2015; Styron, 2015) in healthy older adults as well as their potential in reducing depressive symptoms, physical stress and anxiety (Russoniello, O'Brien, \& Parks, 2009). These findings match general findings from video game training studies reporting improved processing speed, attentional, executive and visuospatial skills (Jak et al., 2013). In addition a recent large-scale study showed that regular engagement in Sudoku and similar puzzles represents a cognitively enriching leisure activity prevents and delays age-related cognitive decline (Ferreira, Owen, Mohan, Corbett, \& Ballard, 2015). Since depressive disorders affect between 10% and 20% older adults and even more in persons suffering from MCI and dementia, and that mood disorders affect about 31% (anxiety disorders up to 40%) patients after suffering a stroke, these populations could potentially draw both cognitive and emotional benefits from CPVG intervention (Arba et al., 2016; Barua, Ghosh, Kar, \& Basilio, 2011; Robinson, 2003).

The main objective of this study is to investigate long-term training benefits of a CPVG intervention on cognitive and emotional functioning in healthy older adults and patients with cognitive impairment.

The primary objective of this study is to examine whether a long-term CPVG intervention significantly improves attentional function (visual search) and leads to in-game learning effects in healthy older participants and cognitively impaired patients (MCI, ABI). The secondary objectives include: a) improvements on further cognitive outcome measures proposed to be engaged by the CPVG (attention, processing speed, working memory and spatial reasoning) and b) the efficacy of the CPVG intervention in reducing symptoms of depression, anxiety and stress and improving quality of life.

Eligibility criteria: Inclusion Criteria:

* Normal or corrected-to-normal visual acuity
* Informed consent as documented by signature
* Healthy older adults:
* Aged 65 years and older
* Absence of cognitive impairment as assessed with a Montreal Cognitive Assessment (MoCA) of above 26.
* Mild cognitive impairment:
* Aged 65 years and older
* Objective cognitive impairment as assessed with a Montreal Cognitive Assessment (MoCA) smaller than 26 (MoCA \< 26).
* Acquired brain injury:
* Diagnosis of acquired brain damage and cognitive impairment (e.g. attentional and executive deficits) as diagnosed through neuropsychological assessment combined with a MoCA score of 26 and smaller

Exclusion Criteria:

* Insufficient coordinative, motor and perceptual ability to handle a tablet- computer.
* Healthy older adults: History of neurological or psychiatric deficits
* Acquired brain injury: History of any other psychiatric deficits
* Mild cognitive impairment: History of any other neurological or psychiatric deficits

Primary outcomes:
measure: Primary outcome measure - Attention: Visual Search
timeFrame: Pre-test (Baseline, week 0)
measure: Primary outcome measure - Attention: Visual Search
timeFrame: Mid-test (Change from Baseline at week 4)
measure: Primary outcome measure - Attention: Visual Search
timeFrame: Post-test (Change from Baseline at week 8)
Secondary outcomes:
measure: Additional attentional outcomes
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Processing speed
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Working memory
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Spatial reasoning
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Emotion and well-being 1
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Emotion and well-being 2
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Emotion and well-being 3
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Self-efficacy
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Intervention compliance
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
measure: Game experience
timeFrame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: ARTORG Center for Biomedical Engineering Research
Study officials:
affiliation: University of Bern
name: Prabitha Urwyler, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oei AC, Patterson MD. Enhancing cognition with video games: a multiple game training study. PLoS One. 2013;8(3):e58546. doi: 10.1371/journal.pone.0058546. Epub 2013 Mar 13.
citation: Stroud MJ, Whitbourne SK. Casual Video Games as Training Tools for Attentional Processes in Everyday Life. Cyberpsychol Behav Soc Netw. 2015 Nov;18(11):654-60. doi: 10.1089/cyber.2015.0316. Epub 2015 Oct 8.
citation: Russoniello CV, O'Brien K, Parks JM. EEG, HRV and Psychological Correlates while Playing Bejeweled II: A Randomized Controlled Study. Stud Health Technol Inform. 2009;144:189-92.
citation: Jak AJ, Seelye AM, Jurick SM. Crosswords to computers: a critical review of popular approaches to cognitive enhancement. Neuropsychol Rev. 2013 Mar;23(1):13-26. doi: 10.1007/s11065-013-9226-5. Epub 2013 Feb 20.
citation: Ferreira N, Owen A, Mohan A, Corbett A, Ballard C. Associations between cognitively stimulating leisure activities, cognitive function and age-related cognitive decline. Int J Geriatr Psychiatry. 2015 Apr;30(4):422-30. doi: 10.1002/gps.4155. Epub 2014 Jul 3.
citation: Arba F, Ali M, Quinn TJ, Hankey GJ, Lees KR, Inzitari D; VISTA Collaboration. Lacunar Infarcts, Depression, and Anxiety Symptoms One Year after Stroke. J Stroke Cerebrovasc Dis. 2016 Apr;25(4):831-4. doi: 10.1016/j.jstrokecerebrovasdis.2015.12.018. Epub 2016 Jan 14.
citation: Barua A, Ghosh MK, Kar N, Basilio MA. Prevalence of depressive disorders in the elderly. Ann Saudi Med. 2011 Nov-Dec;31(6):620-4. doi: 10.4103/0256-4947.87100.
citation: Bleakley CM, Charles D, Porter-Armstrong A, McNeill MD, McDonough SM, McCormack B. Gaming for health: a systematic review of the physical and cognitive effects of interactive computer games in older adults. J Appl Gerontol. 2015 Apr;34(3):NP166-89. doi: 10.1177/0733464812470747. Epub 2013 Jan 17.
citation: Cicerone KD, Azulay J, Trott C. Methodological quality of research on cognitive rehabilitation after traumatic brain injury. Arch Phys Med Rehabil. 2009 Nov;90(11 Suppl):S52-9. doi: 10.1016/j.apmr.2009.05.019.