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Mild Cognitive ImpairmentNCT03139799

Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons

A study testing Experimental - Puzzle Video Game Intervention in people with Mild Cognitive Impairment and Acquired Brain Injury, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
Experimental - Puzzle Video Game Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSwitzerland
Study dates
15 Jul 2020to 31 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • ARTORG Center for Biomedical Engineering Research

    Bern, 3008

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
Experimental - Puzzle Video Game Intervention, Control - Tablet Newspaper Reading Intervention
Medical subject headings
Cognitive Dysfunction, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental - Puzzle Video Game InterventionBehavioural

    The psychological intervention consists of two custom-made versions of popular commercial casual puzzle video games (Flow Free, Big Duck Games LCC; Bejeweled, PopCap Games). The puzzle games are delivered on tablet-computers computer (12.9-inch tablet computer iPad Pro, Apple Inc., Cupertino, CA, USA).

  • Control - Tablet Newspaper Reading InterventionBehavioural

    The control intervention uses a newspaper/ magazine reading task that will be delivered to participants using the same device (iPad Pro) as in the experimental intervention. The newspaper/ magazine reading task will be running on the built-in Apple Newsstand application. Participants will be offered subscriptions for two newspapers and/or magazines that they are instructed to read following the same regime as in the experimental condition.

Study groups in NCT03139799
Study groupRoleWhat they receive
Puzzle Video Game InterventionExperimentalGroup T will first receive the experimental and then the control intervention (T-C) In phase I both groups take a baseline measurement (pre-test), then group T is given the casual puzzle game task (experimental intervention). After phase I (8 weeks) both groups are post-tested (mid-test). In phase II, groups are switched and the the experimental intervention group T now serves as control. After phase II (16 weeks) both groups are post-tested again.
Receives: Behavioral: Experimental - Puzzle Video Game Intervention; Behavioral: Control - Tablet Newspaper Reading Intervention
Tablet Newspaper Reading InterventionActive comparatorGroup C will first receive the the control intervention and then experimental and (C-T). In phase I both groups take a baseline measurement (pre-test), then 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). After phase II (16 weeks) both groups are post-tested again.
Receives: Behavioral: Experimental - Puzzle Video Game Intervention; Behavioral: Control - Tablet Newspaper Reading Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome measure - Attention: Visual Search

    Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery

    Measured: Pre-test (Baseline, week 0)

  2. Primary outcome measure - Attention: Visual Search

    Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery

    Measured: Mid-test (Change from Baseline at week 4)

  3. Primary outcome measure - Attention: Visual Search

    Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery

    Measured: Post-test (Change from Baseline at week 8)

Secondary outcomes (10)
  1. Additional attentional outcomes

    Trail Making Test (TMT) Part A for selective attention and Part B for divided attention

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  2. Processing speed

    Pattern Comparison Test (PCT) for spatial perception speed as well as TMT-A and -B for visual search speed.

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  3. Working memory

    Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) subtests Digit Span (forward, backward and complex) for verbal working memory, Spatial Span (forward and backward) for visuospatial working memory and Spatial Addition for complex visuospatial memory based on the n-back paradigm.

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  4. Spatial reasoning

    Maze Task from the Neuropsychological Assessment Battery (NAB) for planning, organization, reasoning and problem solving.

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  5. Emotion and well-being 1

    Profile of Mood States (POMS) that measures six mood subscales

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  6. Emotion and well-being 2

    State Trait Anxiety Inventory (STAI) that measures anxiety as an emotional state and personality trait

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  7. Emotion and well-being 3

    World Health Organization's WHOQOL-BREF quality of life assessment

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  8. Self-efficacy

    Assessed with the General Self-Efficacy Scale

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  9. Intervention compliance

    The data saved each time the participants engage in a session of the casual puzzle game intervention will serve as a measure of gameplay frequency and intervention compliance.

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

  10. Game experience

    Measured with the Perception of Training Questionnaire

    Measured: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start15 Jul 2020
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139799
Sponsor's protocol ID
2016-01281
Other IDs
2016
Status last verified
Nov 2022
First submitted
26 Apr 2017
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23516504
  • 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.

    PubMed 26448498
  • 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.

    PubMed 19592761
  • 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.

    PubMed 23423553
  • 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.

    PubMed 24989949
  • 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.

    PubMed 26778600
  • 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.

    PubMed 22048509
  • 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.

    PubMed 24652863
  • 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.

    PubMed 19892075

Questions about this trial

What is this clinical trial studying?

A study testing Experimental - Puzzle Video Game Intervention in people with Mild Cognitive Impairment and Acquired Brain Injury, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome measure - Attention: Visual Search (time frame: Pre-test (Baseline, week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03139799, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

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