Effectiveness of Cognitive Training in Older and Younger Adults

NCT06375681 | Recruiting

• 3 other identifiers: 2019-1378: R011R01AG076157-01A487400
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 3

Brief Summary

The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks.

Conditions

Cognitive Change

Keywords

Cognitive Training; Training task; Testing context

Outcome Measures

Primary Outcomes (14)

• Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task

  The n-Back Task is a measure of working memory. The participant is sequentially shown a series of letters and is asked to indicate whether the current letter matches the letter presented "n" items before. The n levels range between 1- and 4-back. Each level of n-back has 17-19 letters, with 5 target letters.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the proportion of correctly reported sequences in the Corsi Complex task

  The Corsi Complex Task is a measure of working memory. The participant is sequentially shown a series of positions from 12 possible predefined spots on the screen. Between each position, the participants is also asked to categorize a stimulus between two categories based on color and shape. The participant's task is to report the sequence of positions in order. The length of sequence can vary between 2 and 10.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the proportion of correctly reported number and letter sets in the Letter-Number task

  The Letter-Number Sequence Task is a measure of working memory. In each trial, the participant is presented with a sequence of alternating letters and numbers, from 2 to 10 stimuli. Participants have to report the numbers in ascending order, and the letters in alphabetical order.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task

  The Task Switching task is a measure of cognitive flexibility. On each trial, participants view a letter and a digit. A cue tells the participant to either categorize the letter as a consonant or vowel or else categorize the digit as even or odd. Trials can be either "non-switch trials" - in which the participant is asked to perform the same task as on the previous trial - or "switch trials" - in which the participant is asked to perform the opposite task as on the previous trial. The participant will complete 48 trials. A "switch cost" is calculated by subtracting the average response time for switch trials from the average response time for non-switch trials.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task

  In the Flanker task, the participant is asked to indicate whether the centrally presented arrow is pointing either to the left or right by pressing the left or right triangular buttons. This arrow is surrounded by 4 identical arrows, 2 to its left and 2 to its right; these are called non-target arrows. The participant is presented with two different trial types during the task, incongruent and congruent. In the congruent trials, the non-target arrows point in the same direction as the target arrow (e.g. all to the left) and in the incongruent trials they point in the opposite direction (e.g. target to the right, non-targets to the left). Switch trials are trials preceded by a trial of the opposite category (i.e. congruent preceded by incongruent or incongruent preceded by congruent).

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task

  The Cancellation task is a measure of cognitive flexibility. Participants are presented with rows of 8 stimuli that can be either cats or dogs. Each cat and dog varies along its orientation, color pattern, and/or stance, giving 4 distinct cats and 4 distinct dogs. One cat and one dog are targets, and the rest are distractors. The goal of the participant is to mark as many targets as possible within each row in the allotted time (210 seconds).

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the proportion of correct responses on the Useful Field of View (UFOV) Task

  The UFOV is a measure of visual selective attention. Participants are briefly presented with a display consisting of 24 peripheral items (3 on each of the four radial spokes and the four obliques; evenly spaced) and 1 central stimulus (a smiley with either long or short hair). One of the peripheral items is a target, while the remaining items are distractors. The participants' task is to indicate upon which of the 8 spokes the target appeared, and whether the central smiley had short or long hair. The display times vary between 16-500ms.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task

  The MOT is a measure of visual divided attention. On each trial, participants view a series of blue and yellow smiley faces randomly moving in circular area. After a few seconds, the blue faces become yellow, indistinguishable from the distractors, while all the items keep moving on the screen. After another period of a few seconds, the items stop, and the participant is asked whether a randomly selected face was initially blue or yellow at the beginning of the trial.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the response time and percentage of correct responses in the Mental Rotation Task

  The mental rotation task is a measure of spatial cognition. Each trial displays two 2-D images, and the participant is asked whether the image on the right is a rotated version or a mirror-reserved and rotated version of the image on the left. The participant will complete 36 trials.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the percentage of correct responses in the Paper Folding task

  The Paper Folding task is a measure of mental rotation. Participants are shown 2-4 images depicting a piece of paper being folded with a hole being punched after the last fold. The participant is asked to imagine and indicate what the paper would look like unfolded. The participant will complete 10 trials.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task

  Raven's Advanced Progressive Matrices task is a measure of fluid intelligence. The participant is presented with a grid of elements with one of the elements missing and is asked to identify the missing element that completes the grid pattern. The participant will complete 14 trials.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the sum of correctly solved items in the UC Matrix Reasoning task

  The UC Matrix Reasoning task is a measure of fluid intelligence. The participant is presented with a grid of elements with one of the elements missing and is asked to identify the missing element that completes the grid pattern. The participant will complete 16 trials.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the percentage of accuracy in the Shipley Institute of Living Scale

  Participants will complete Part I of the Shipley Institute of Living Scale, which is a measure of vocabulary. Participants are asked to select the appropriate synonym for a target word among several alternatives for 15 words.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

• Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale

  In this vocabulary task, participants are asked to select the appropriate synonym for a target word among several alternatives for 25 words.

  Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

Secondary Outcomes (13)

• Big-5-Inventory 10-item version (BFI-10) Score

  Pre-Test

• Behavioral Inhibition/Activation System (BIS/BAS) Score

  Pre-Test

• Grit and Conscientiousness Score

  Pre-Test

• Meta-Cognition Score

  Pre-Test

• Theories of Intelligence - Mindset (Fixed vs Growth) Score

  Pre-Test

Study Arms (2)

Short Testing Group

ACTIVE COMPARATOR

Participants will go through 2 assessment sessions over 2-3 days (\~75 minutes each), followed by 1 session of 75 minutes about 2 weeks later, 2 further sessions (\~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (\~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

Behavioral: Visual and / or Auditory Cognitive Tasks (1)

Long Testing Group

ACTIVE COMPARATOR

Participants will go through 2 assessment sessions over 2-3 days (75 minutes each), followed by 10 sessions of cognitive tasks over 2 weeks, 1 session of 75 minutes about 2 weeks later, another 10 sessions of cognitive tasks over 2 weeks, then 2 sessions (\~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (\~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

Behavioral: Visual and / or Auditory Cognitive Tasks (1); Behavioral: Visual and / or Auditory Cognitive Tasks (2)

Interventions

Visual and / or Auditory Cognitive Tasks (1) BEHAVIORAL

Seven sessions (\~45-75 minutes) of cognitive tasks in the lab. Participants asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers and asked to make simple judgements.

Long Testing Group; Short Testing Group

Visual and / or Auditory Cognitive Tasks (2) BEHAVIORAL

Two sets of 10 sessions (\~20 minutes) of cognitive tasks either at home or in the lab. Participants asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers and asked to make simple judgements.

Long Testing Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported normal or corrected-to-normal vision
• No known neurological impairments

You may not qualify if:

• Physical handicap (motor or perceptual) that would impede training procedures
• Concurrent enrollment in other cognitive training studies
• Not being proficient enough in English that would prevent following and understanding all instructions and completing all testing sessions (typically, participants would need to have learned English before age 11; there might be some exceptions that will be decided on a case-by-case basis).
• Unable to adhere to training schedule
• \- Score \< 17 (out of 22) on the Telephone Montreal Cognitive Assessment (T-MoCA).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

University of California, Riverside

Riverside, California, 92521, United States

RECRUITING

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

RECRUITING

Study Officials

• Aaron R. Seitz, PhD

  University of California, Riverside

  PRINCIPAL INVESTIGATOR

• Susanne M. Jaeggi, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C. Shawn Green, PhD

CONTACT

(608) 263-4868; cshawn.green@wisc.edu

Freya Joessel, PhD

CONTACT

joessel@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All researchers that have contact with participants will be unaware of the tested hypothesis of the study. Participants will be unaware of the experimental conditions. Researchers and participants will be unaware (blinded) to the game conditions assigned to the participant, except for researchers in charge of supervising the training part of the study who will be aware what training the participant is undergoing. More information on how this was achieved will be registered after data collection is completed to preserve the scientific integrity of the study.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following Pre-testing, participants randomly assigned into the full study will be further randomly assigned to a total of 9 unique experimental conditions for the full 2x2x2+1 factorial design. The full description of the study's 9 arms will be registered after data collection is completed to preserve the scientific integrity of the study.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available persistently at the conclusion of the study.
• Access Criteria: There are no access criteria.

Locations

US (3)