NCT05468424

Brief Summary

The primary objective of this study is to investigate whether a tablet-based role-playing game is more effective than tablet-based word or image puzzles at improving executive functions in older adults with mild cognitive impairment. The secondary objective of this study is to investigate whether a tablet-based role-playing game will show higher levels of engagement (measured by time played) in older adults with mild cognitive impairment than tablet-based word or image puzzles.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

June 29, 2022

Last Update Submit

January 17, 2024

Conditions

Keywords

video games, tablet

Outcome Measures

Primary Outcomes (11)

  • response inhibition

    Double Trouble (Cambridge Brain Science, n.d., p. 3) - "A variant on the Stroop task (Stroop, 1935). Three coloured words are displayed on the screen: one at the top and two at the bottom. Participants must indicate which of two coloured words at the bottom of the screen (ignoring the colour of those words) correctly describes the colour that the word at the top of the screen is written in" (p. 3). Participants have 90 seconds to solve as many problems as possible. The task is scored on the number of correctly answered problems minus the number of incorrectly answered problems.

    8 weeks

  • attention

    Feature Match (Cambridge Brain Science, n.d., p. 4) - "Based on the classical feature search tasks that have been used to measure attentional processing (Treisman \& Gelade, 1980). Two grids are displayed on the screen, each containing an array of abstract shapes. In half of the trials the grids differ by just one shape. Participants must indicate whether or not the grid's contents are identical. Difficulty is increased or decreased by one shape depending on whether the participant got the previous trial correct" (p. 4). Participants have 90 seconds to solve as many problems as possible. The task is scored on the sum of the difficulties of all correctly answered problems minus the sum of the difficulties of all incorrectly answered problems.

    8 weeks

  • verbal short-term memory

    Digit Span (Cambridge Brain Science, n.d., p. 4) - "A variant on the verbal working memory component of the WAIS-R (Weschler, 1981). A sequence of numbers will appear on the screen one after another. Once the sequence is complete, participants must repeat the sequence. Difficulty is increased or decreased by one number depending on whether the participant got the previous trial correct" (p. 4). After three errors, the task ends. The task is scored on the maximum level (e.g. the problem with the highest number of digits) that the participant successfully completed.

    8 weeks

  • spatial short-term memory

    Spatial Span (Cambridge Brain Science, n.d., p. 6) - "A variant on the Corsi Block Tapping Task (Corsi, 1972). Sixteen squares are displayed in a 4 x 4 grid. A sub-set of the squares flash in a random sequence at a rate of 1 flash every 900 ms. Participants must repeat the sequence by clicking on the squares in the same order in which they flashed. Difficulty is increased or decreased by one square depending on whether the participant got the previous trial correct" (p. 6). After three errors, the task ends. The task is scored on the maximum level (e.g. the problem with the highest number of targets) that the participant successfully completed.

    8 weeks

  • working memory

    Token Search (Cambridge Brain Science, n.d., p. 6) - "Based on a test that is used to measure strategy during search behaviours (Collins et al.,1998). Boxes are displayed in random locations. Participants must find a hidden "token" by clicking on the boxes one at a time. When the token is found, it is hidden within another box. The token will not appear within the same box twice, thus, participants must search the boxes until the token has been found once in each box. If they search the same empty box twice, or search a box in which the token has previously been found, this is an error and the trial ends. Difficulty is increased or decreased by one box depending on whether the participant got the previous trial correct" (p. 6). After three errors, the task will end. The task is scored on the maximum level (e.g. the problem with the most tokens) that the participant successfully completed.

    8 weeks

  • visuospatial working memory

    Monkey Ladder (Cambridge Brain Science, n.d., p. 5) - "A variant on a task from the non-human primate literature (Inoue \& Matsuzawa, 2007). Sets of numbered squares are displayed on the screen at random locations. After a variable interval of time, the numbers disappear leaving just the blank squares and participants must respond by clicking the squares in ascending numerical sequence. Difficulty is increased or decreased by one numbered box depending on whether the participant got the previous trial correct" (p. 5). After three errors, the task ends. The task is scored on the maximum level (e.g. the problem with the highest number of boxes) that the participant successfully completed.

    8 weeks

  • visuospatial rotations

    Rotations (Cambridge Brain Science, n.d., p. 6) - "Used for measuring the ability to manipulate objects spatially in mind (Silverman et al., 2000). Two grids of coloured squared are displayed to either side of the screen with one of the grids rotated by a multiple of 90 degrees. When rotated, the grids are either identical or differ by the position of just one square. Participants must indicate whether or not the grids are identical" (p. 6). Participants have 90 seconds to solve as many problems as possible. The task is scored on the sum of the difficulties of all correctly answered problems minus the sum of the difficulties of all incorrectly answered problems.

    8 weeks

  • visuospatial processing

    Polygons (Cambridge Brain Science, n.d., p. 4) - "Based on the Interlocking Pentagons task (Folstein et al., 1975). A pair of overlapping polygons is displayed on one side of the screen. Participants must indicate whether a polygon displayed on the other side of the screen is identical to one of the interlocking polygons. Difficulty is increased by making the differences between the polygons more subtle or decreased by making the differences between the polygons more pronounced" (p. 4). Participants have 90 seconds to solve as many problems as possible. The task is scored on the sum of the difficulties of all correctly answered problems minus the sum of the difficulties of all incorrectly answered problems.

    8 weeks

  • deductive reasoning

    Odd One Out (Cambridge Brain Science, n.d., p. 3) - "Based on a sub-set of problems from the Cattell Culture Fair Intelligence Task (Cattell, 1949). Nine patterns will appear on the screen. The features that make up the patterns are colour, shape, and number and are related to each other according to a set of rules. Participants must deduce the rules that relate the object features and select the pattern that do not correspond to those rules. Difficulty is increased or decreased depending on whether the participant got the previous trial correct" (p. 3). Participants have 3 minutes to solve as many problems as possible. The task is scored on the number of correctly answered problems minus the number of incorrectly answered problems.

    8 weeks

  • verbal reasoning

    Grammatical (Cambridge Brain Science, n.d., p. 5) - "Based on Baddeley's three minute grammatical reasoning task (Baddeley, 1968). Short sentences describing the relationship of two shapes along with an image of the shapes are displayed on the screen. Participants must indicate whether the sentence correctly describes the pair of objects displayed on the screen" (p. 5). Participants have 90 seconds to solve as many problems as possible. The task is scored on the number of correctly answered problems minus the number of incorrectly answered problems.

    8 weeks

  • planning

    Spatial Planning (Cambridge Brain Science, n.d., p. 7) - "A direct descendant of the 'Tower of London' planning task (Shallice, 1982). When the task begins, numbered beads are positioned on a tree-shaped frame. Participants must reposition the beads so they are configured in ascending numerical order, in as few moves as possible. Problems become progressively harder" (p. 7). Participants have three minutes to solve as many problems as possible. The task is scored by subtracting the total number of moves made from twice the minimum number of moves required.

    8 weeks

Secondary Outcomes (1)

  • engagement

    8 weeks

Study Arms (2)

FarmVille

EXPERIMENTAL

tablet (iPad or android) based role-playing game (FarmVille)

Other: tablet (iPad or android) based role-playing game

puzzle games

ACTIVE COMPARATOR

selection of tablet (iPad or android) based word puzzles (Word Search Ultimate and Word Cookies) and image puzzles (Flow Free and Jigsaw HD)

Other: tablet (iPad or android) based word puzzles and image puzzles

Interventions

The intervention is a tablet (iPad or android) based role-playing game called FarmVille. In FarmVille the player assumes the role of a farmer tasked with tending to crops and farm animals and using what is produced to craft goods which can be sold to expand the farm. The participant is required to play FarmVille for 5 or more hours a week for 8 weeks.

FarmVille

This intervention is a selection of tablet (iPad or android) word puzzles and image puzzles. One word puzzle involves "word making" (i.e., making words from a set of random letters), and the other "word searching" (i.e., finding words on a grid of letters). One image puzzle is Flow Free, a game that requires the player to connect pairs of same coloured dots positioned on a grid ranging from 5x5 to 9x9. The other image puzzle is a jigsaw. The participant is required to play these games for 5 or more hours a week for 8 weeks.

puzzle games

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • fluent in English
  • diagnosis of mild cognitive impairment
  • normal or corrected hearing and vision
  • can operate the touch screen on an iPad
  • access to a tablet (iPad or android) for 8 weeks of the study

You may not qualify if:

  • have started taking memory medication in the last 3 months
  • have experience in any of the tablet-based games included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence Care Hospital

Kingston, Ontario, K7L4X3, Canada

Location

Baycrest Academy

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (14)

  • Baddeley, AD (1968). A 3 min reasoning test based on grammatical transformation. Psychonomic Science, 10(10), 341-342.

    BACKGROUND
  • Cambridge Brain Sciences (n.d.). Cambridge Brain Sciences Task Overview. Retrieved from https://www.cambridgebrainsciences.com/assets/partners/cbs-health---science-overview.pdf.

    BACKGROUND
  • Cattell, RB (1949). Culture free intelligence test, Scale 1, handbook.1. Institute of Personality and Ability, Champaign, Illinois.

    BACKGROUND
  • Collins P, Roberts AC, Dias R, Everitt BJ, Robbins TW. Perseveration and strategy in a novel spatial self-ordered sequencing task for nonhuman primates: effects of excitotoxic lesions and dopamine depletions of the prefrontal cortex. J Cogn Neurosci. 1998 May;10(3):332-54. doi: 10.1162/089892998562771.

    PMID: 9869708BACKGROUND
  • Corsi, PM (1972). Human memory and the medial temporal region of the brain. Dissertation Abstracts International, 34(2-B), 891.

    BACKGROUND
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND
  • Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022.

    PMID: 23259956BACKGROUND
  • Inoue S, Matsuzawa T. Working memory of numerals in chimpanzees. Curr Biol. 2007 Dec 4;17(23):R1004-5. doi: 10.1016/j.cub.2007.10.027. No abstract available.

    PMID: 18054758BACKGROUND
  • Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.

    PMID: 10190820BACKGROUND
  • Shallice T. Specific impairments of planning. Philos Trans R Soc Lond B Biol Sci. 1982 Jun 25;298(1089):199-209. doi: 10.1098/rstb.1982.0082.

    PMID: 6125971BACKGROUND
  • Silverman I I, Choi J, Mackewn A, Fisher M, Moro J, Olshansky E. Evolved mechanisms underlying wayfinding. further studies on the hunter-gatherer theory of spatial sex differences. Evol Hum Behav. 2000 May 1;21(3):201-213. doi: 10.1016/s1090-5138(00)00036-2.

    PMID: 10828558BACKGROUND
  • Stroop, JR (1935). Studies of interference in serial verbal reactions. Journal of Experimental Psychology, 18(6), 643-661. doi: 10.1037/h0054651.

    BACKGROUND
  • Treisman AM, Gelade G. A feature-integration theory of attention. Cogn Psychol. 1980 Jan;12(1):97-136. doi: 10.1016/0010-0285(80)90005-5. No abstract available.

    PMID: 7351125BACKGROUND
  • Wechsler. D. (1981). Wechsler Adult Intelligence Scale - Revised. Manual. New York: Psychological Corporation.

    BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Tablets

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • John Puxty, MD

    Providence Care Hospital

    PRINCIPAL INVESTIGATOR
  • Nicole Anderson, PhD

    Baycrest Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Chair of Geriatric Medicine

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 21, 2022

Study Start

November 3, 2022

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations