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Effect of Tablet-Based Games on Executive Functions in Older Adults With Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05468424
Recruitment Status : Not yet recruiting
First Posted : July 21, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
John Puxty, Queen's University

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: tablet (iPad or android) based role-playing game Other: tablet (iPad or android) based word puzzles and image puzzles Not Applicable

Detailed Description:
The purpose of this study is to examine the use of tablet-based (iPad or android) video games as a means of improving executive functions in older adults with Mild Cognitive Impairment (Petersen, Smith, Waring, et al., 1999). The worldwide rising average age of the population and increasing incidence of dementia has created an urgent need for the development of effective and engaging therapies to mitigate age- and dementia-related cognitive decline. Much evidence supports the use of cognitive therapies as a means of improving general cognition in older adults. Video games may offer benefits over traditional cognitive therapies as they are challenging and fun, provide frequent feedback which motivates and encourages user engagement, and are widely available at low cost on tablet devices. This study will be implemented as a single blinded randomized control trial structured as a 2 x 2 mixed design with one repeated factor (time: pre-training, post-training) and one between-subject factor (group: treatment, active control). Forty-two older adults with Mild Cognitive Impairment, along with their study partner, will be randomly assigned to play either a role-playing game, or a selection of word or image puzzles, for 5 or more hours a week for a period of 8 weeks. Participants will be assessed pre and post training with the Cambridge Brain Sciences (www.cambridgebrainsciences.com) online battery of 12 cognitive tasks. These tasks are "based on well-established paradigms from the cognitive neuroscience literature, to measure planning, reasoning, attention, and working memory abilities" (Hampshire, Highfield, Parkin, et al., 2012, p. 1236).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tablet-Based Games on Executive Functions in Older Adults With Mild Cognitive Impairment
Estimated Study Start Date : September 12, 2022
Estimated Primary Completion Date : September 2, 2023
Estimated Study Completion Date : September 2, 2023

Arm Intervention/treatment
Experimental: FarmVille
tablet (iPad or android) based role-playing game (FarmVille)
Other: tablet (iPad or android) based role-playing game
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.Their study partner can remind them to play the game each week and can assist them with issues related to using the tablet and navigating menus in the game.

Active Comparator: puzzle games
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
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.Their study partner can remind them to play the games each week and can assist them with issues related to using the tablet and navigating menus in the games.




Primary Outcome Measures :
  1. response inhibition [ Time Frame: 8 weeks ]
    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.

  2. attention [ Time Frame: 8 weeks ]
    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.

  3. verbal short-term memory [ Time Frame: 8 weeks ]
    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.

  4. spatial short-term memory [ Time Frame: 8 weeks ]
    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.

  5. working memory [ Time Frame: 8 weeks ]
    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.

  6. visuospatial working memory [ Time Frame: 8 weeks ]
    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.

  7. visuospatial rotations [ Time Frame: 8 weeks ]
    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. visuospatial processing [ Time Frame: 8 weeks ]
    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.

  9. deductive reasoning [ Time Frame: 8 weeks ]
    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.

  10. verbal reasoning [ Time Frame: 8 weeks ]
    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.

  11. planning [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. engagement [ Time Frame: 8 weeks ]
    The participants are given a Game Play Log on which they log daily the (1) minutes played, (2) minutes of study partner assistance provided, and (3) level achieved in the game.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 60 years of age or older
  • fluent in English
  • clinical diagnosis of Mild Cognitive Impairment
  • normal or corrected visual and auditory acuity
  • sufficient manual dexterity to operate a tablet
  • access to a tablet for the duration of the study
  • availability of a study partner who is fluent in English to monitor playing the assigned tablet-based games for a period of 8 weeks

Exclusion Criteria:

  • recent (i.e., last 3 months) initiation of treatment with cognitive enhancement medications such as Donepezil, Rivastigmine, Galantamine, or Memantine
  • experience in any of the tablet-based games included in the treatment or active control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468424


Contacts
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Contact: April Clausen, M.Ed. 9058720721 2allc@queensu.ca

Locations
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Canada, Ontario
Providence Care Hospital
Kingston, Ontario, Canada, K7L4X3
Contact: John Puxty, MD    6135444900 ext 53257    puxtyj@providencecare.ca   
Principal Investigator: April Clausen, M.Ed.         
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: John Puxty, MD Providence Care Hospital
Additional Information:
Publications:
Baddeley, AD (1968). A 3 min reasoning test based on grammatical transformation. Psychonomic Science, 10(10), 341-342.
Cambridge Brain Sciences (n.d.). Cambridge Brain Sciences Task Overview. Retrieved from https://www.cambridgebrainsciences.com/assets/partners/cbs-health---science-overview.pdf.
Cattell, RB (1949). Culture free intelligence test, Scale 1, handbook.1. Institute of Personality and Ability, Champaign, Illinois.
Corsi, PM (1972). Human memory and the medial temporal region of the brain. Dissertation Abstracts International, 34(2-B), 891.
Stroop, JR (1935). Studies of interference in serial verbal reactions. Journal of Experimental Psychology, 18(6), 643-661. doi: 10.1037/h0054651.
Wechsler. D. (1981). Wechsler Adult Intelligence Scale - Revised. Manual. New York: Psychological Corporation.

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Responsible Party: John Puxty, Associate Professor, Chair of Geriatric Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT05468424    
Other Study ID Numbers: 6035589
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Puxty, Queen's University:
video games, tablet
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders