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Strategic Training to Optimize Neurocognitive Functions in Older Adults (ViCTOR)

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ClinicalTrials.gov Identifier: NCT03988829
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
National Institute on Aging (NIA)
Information provided by (Responsible Party):
The University of Texas at Dallas

Brief Summary:
The goal of the present randomized control trial is to evaluate the efficacy of a novel cognitive training approach using simulated games, where older adults will learn to flexibly deploy attentional control during working memory, for prevention of Alzheimer's Disease (AD). Based on our extensive pilot work, we expect training-related enhancements in both neural and cognitive functions on a broad range of cognitive abilities due to the importance of attentional control and working memory in many types of cognition. These outcomes are widely applicable to the cognitive health and the quality of life of elderly Americans, and have further potential to offset degenerative processes common to normal aging.

Condition or disease Intervention/treatment Phase
Cognitive Aging Functional Magnetic Resonance Imaging Behavioral: Low-C Behavioral: High-C Behavioral: High-C+ Not Applicable

Detailed Description:

Almost all older adults experience cognitive frailty with age, with around one-third of adults aged 85 or older suffering from Alzheimer's disease (AD). Cognitive frailty, particularly AD, threatens to overwhelm medical resources in the United States and much of the developed world. Therefore, it is important that we learn how to optimize and maintain cognitive performance in cognitively-frail older adults, particularly those who are at high-risk of suffering from AD, such as adults over 70 years of age where more than half express AD pathology. The present multi-arm randomized control trial takes a novel theory-driven approach to enhancing cognition in older adults by training them to flexibly deploy attentional focus in working memory. Flexibility in allocating and switching attentional resources will be trained by having participants respond to unpredictable cues in working memory. The ability to flexibly and efficiently allocate attentional control underlies successful performance on a broad array of cognitive tasks. Hence, training in this area may enhance performance not only on related tasks (near transfer), but also on tasks that are perceptibly not related to the training task (far transfer).

The current proposal has three training arms, and utilizes game-based simulations in all arms in healthy older adults. The first two arms use experimenter-designed simulation games, where participants will be trained on either predictable low attentional control (Arm 1) or unpredictable high attentional control (Arm 2) working memory games. The third arm uses a commercially available strategy game requiring highest level of attentional control, by adding multi-tasking to the unpredictable attentional shifts in working memory. In all three training arms, neural and cognitive changes in near (secondary outcome) and far (primary outcome) transfer tasks will be examined immediately after intervention; cognitive changes will also be assessed at 6-month post-training duration. Additionally, a single-session, baseline neuroimaging data (no training) will be collected in a functional control group of younger adults. We expect that the high attentional control training arms will greatly improve both near and far cognition in older adults, with cognitive frailty interacting with the extent to which attentional control is trained. High attentional control training arms are also expected to heighten compensatory brain activation after intervention, for both near and far in-scanner transfer tasks, mimicking the baseline activity of younger brains. These training arms are also expected to positively impact brain structures that progressively decline with aging. This clinical trial will result in development of behavioral intervention tools, which will have the potential to delay the onset of memory-related disorders, such as AD, by instantiating durable improvements in cognitive functions in older adults. Such interventions can not only improve an individuals' quality of life, but also decrease the financial burden of a rapidly aging society.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

We will conduct a randomized control trial on healthy older adults, where attentional control demands in cognitive training will be systematically increased using engaging game-based simulations. There are three parallel arms: predictable low attentional control (Arm 1: Low-C), unpredictable high attentional control (Arm 2: High-C), and a commercially-available strategy video game (Arm 3: High-C+). In all three training arms, neural and cognitive changes in both near and far tasks will be examined immediately after the 8-week long intervention. Long-term cognitive changes will also be assessed at 6 months after completion of training. The far and near cognitive outcomes that will be examined are episodic memory (the primary cognitive outcome) and executive control (the secondary cognitive outcome).

Additionally, a single-session functional neuroimaging dataset will be collected in a control group of younger adults; they will not undergo any intervention.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

If a volunteer meets the inclusion and exclusion criteria, he or she will be randomized into one of the three training arms. This assignment will be based on a random computerized allocation plan, where the average cognitive frailty, age, education and gender distribution will be maintained to be equivalent across the three arms. To maintain the balance between the arms, we will randomize between blocks of 15 participants. By randomly assigning participants in the training arms and by assessing outcomes by blinded experimenters, we will avoid selection bias and outcome assessment bias.

The PI will be blinded to training assignment of any subject, and will only analyze de-identified data.

Primary Purpose: Prevention
Official Title: Strategic Training to Optimize Neurocognitive Functions in Older Adults
Actual Study Start Date : September 30, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Low-C
In an experimenter-designed simulation game, participants will be trained on predictable low attentional control shifts during working memory.
Behavioral: Low-C
This is the active control group, where participants will be trained to play an experimenter developed game that requires least attentional control among all arms.

Experimental: High-C
In an experimenter-designed simulation game, participants will be trained on unpredictable high attentional control shifts during working memory.
Behavioral: High-C
In this intervention, participants will be trained on this experimenter developed game which requires a lot of attentional control.
Other Name: Unpredictable Bird Watch

Experimental: High-C+
In this commercially-available video game, in addition to unpredictable shifts of attentional control in working memory, task switching and resource planning will be trained.
Behavioral: High-C+
A commercial video game will be used that requires a lot of demand on attentional control.
Other Name: Video Game




Primary Outcome Measures :
  1. Immediate Change in the Composite Score of Episodic Memory [ Time Frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment) ]

    Change in composite score of episodic memory from baseline to post-training (i,.e., after 8 week of training). The composite score of episodic memory will include correct responses from 3 episodic memory tasks:

    1. Picture Sequence Memory
    2. RVLT
    3. Story Recall (MMSE)

    For all tasks, alternative forms will be used for baseline testing and for post-training. Details of the tasks are listed below:

    1. Participants are asked to reproduce a sequence of pictures that is shown on the screen.
    2. Fifteen words are read to participants. Immediately after, the participant is asked to recall the entire list. This is repeated a few times.
    3. A short story is read to participant. Immediately after, the participant is asked to repeat the story.

  2. 6-month Change in the Composite Score of Episodic Memory [ Time Frame: 8 months (=6 mo of retention + 9-10 weeks) ]

    Change in composite score of episodic memory from baseline to 6-months after completion of training (i.e., after 8 week of training). The composite score of episodic memory will include correct responses from 3 episodic memory tasks:

    1. Picture Sequence Memory
    2. RVLT
    3. Story Recall (MMSE)


Secondary Outcome Measures :
  1. Immediate Change in the Composite Score of Executive Control [ Time Frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment) ]

    Change in composite score of episodic memory from baseline to post-training (i,.e., after 8 week of training). The composite score of executive control will include correct responses from 6 tasks:

    1. Task Switching RT
    2. Dimensional Change Accuracy
    3. Flanker RT
    4. Stroop RT
    5. Visual N-back RT
    6. Verbal Memory Updating Accuracy

    For all tasks, alternative forms will be used for baseline testing and for post-training.


  2. 6-month Change in the Composite Score of Executive Control [ Time Frame: 8 months (=6 mo of retention + 9-10 weeks) ]

    Change in composite score of executive control from baseline to 6-months after completion of training (i.e., after 8 week of training). The composite score of executive control will include correct responses from 6 tasks:

    1. Task Switching RT
    2. Dimensional Change Accuracy
    3. Flanker RT
    4. Stroop RT
    5. Visual N-back RT
    6. Verbal Memory Updating Accuracy

    Alternate forms will be used at baseline and at 6-months after completion of training.



Other Outcome Measures:
  1. Immediate Change in the Composite Score of Reasoning [ Time Frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment) ]

    Change in composite score of Reasoning from baseline to post-training (i,.e., after 8 week of training). The composite score of reasoning will include correct responses from 2 tasks:

    1. Matrix Reasoning
    2. Visual Puzzle

    For all tasks, alternative forms will be used for baseline testing and for post-training.


  2. Immediate Change in the Composite Score of Working Memory Capacity [ Time Frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment) ]

    Change in composite score of Working Memory Capacity from baseline to post-training (i,.e., after 8 week of training). The composite score of working memory capacity will include correct responses from 2 tasks:

    1. List Sorting Working Memory
    2. Complex Span

    For all tasks, alternative forms will be used for baseline testing and for post-training.


  3. 6-month Change in the Composite Score of Reasoning [ Time Frame: 8 months (=6 mo of retention + 9-10 weeks) ]

    Change in composite score of Reasoning from baseline to 6-months after completion of training (i.e., after 8 week of training). The composite score of reasoning will include correct responses from 2 tasks:

    1. Matrix Reasoning
    2. Visual Puzzle

    For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training.


  4. 6-month Change in the Composite Score of Working Memory Capacity [ Time Frame: 8 months (=6 mo of retention + 9-10 weeks) ]

    Change in composite score of Working Memory Capacity from baseline to 6-months after completion of training (i.e., after 8 week of training). The composite score of working memory capacity will include correct responses from 2 tasks:

    1. List Sorting Working Memory
    2. Complex Span

    For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training.


  5. Immediate Change in the Composite Score of Psychosocial Functioning - MIDUS-II [ Time Frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment) ]

    Change in composite score of Psychosocial Functioning from baseline to post-training (i,.e., after 8 week of training). The composite score of psychosocial functioning will include correct responses from 4 tasks:

    1. MIDUS-II
    2. Cognitive Reserve Index
    3. Rivermead Behavioral Memory Test - III
    4. New general Self-efficacy Scale

    For all tasks, alternative forms will be used for baseline testing and for post-training.


  6. 6-month Change in the Composite Score of Psychosocial Functioning - MIDUS-II [ Time Frame: 8 months (=6 mo of retention + 9-10 weeks) ]

    Change in composite score of Psychosocial Functioning from baseline to 6-months after completion of training (i.e., after 8 week of training). The composite score of psychosocial functioning will include correct responses from 4 tasks:

    1. MIDUS-II
    2. Cognitive Reserve Index
    3. Rivermead Behavioral Memory Test - III
    4. New general Self-efficacy Scale

    For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training.


  7. Immediate Change in Processing Speed [ Time Frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment) ]

    Change in numbers of items correctly coded within 2 minutes on the Digit Symbol Substitution task from baseline to post-training (i,.e., after 8 week of training).

    Alternative forms will be used for baseline testing and for post-training.


  8. 6-month Change in Processing Speed [ Time Frame: 8 months (=6 mo of retention + 9-10 weeks) ]

    Change in numbers of items correctly coded within 2 minutes on the Digit Symbol Substitution task from baseline to post-training (i,.e., after 8 week of training).

    Alternative forms will be used for baseline testing and at 6-months after completion of training.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least a 10th grade education
  • Learned English before age 5
  • If female, not pregnant or likely to be pregnant
  • Right-handed
  • Mini Mental State (MMSE) score of 26 or greater (for older adults only), Montreal Cognitive Assessment (MoCA) score of 24 or more (for older adults only)
  • The physical and sensory capacity sufficient to undertake a functional magnetic resonance imaging study

Exclusion Criteria:

  • Color blindness assessed by the Ishihara Test for Color Deficiency
  • Visual acuity of less than 20/30 on the Snellen eye chart after correction
  • Diagnosis of any major psychiatric or neurologic disorders
  • History of cardiovascular disease other than treated hypertension
  • Illness or trauma affecting the central nervous system
  • Substance/alcohol abuse, and medication with anti-depressants, anti-psychotics, or hypnotics other than occasionally at bedtime
  • Structural magnetic resonance imaging reveal evidence of pathology (e.g. infarction)

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): NCT03988829


Contacts
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Contact: Evan T Smith, MA 972-883-3761 exs130130@utdallas.edu
Contact: Paulina A Skolasinska, MA 972-883-3777 pas170003@utdallas.edu

Locations
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United States, Texas
The Center for Vital Longevity (UT Dallas) Recruiting
Dallas, Texas, United States, 75235
Contact: Evan T Smith, MA    972-883-3761    exs130130@utdallas.edu   
Contact: Paulina A Skolasinska, MA    9728833777    pas170003@utdallas.edu   
Principal Investigator: Chandramallika Basak, PhD         
Sponsors and Collaborators
The University of Texas at Dallas
University of Texas Southwestern Medical Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Chandramallika Basak, PhD The University of Texas at Dallas
  Study Documents (Full-Text)

Documents provided by The University of Texas at Dallas:
Informed Consent Form: Older adults  [PDF] January 25, 2019
Informed Consent Form: Younger adults  [PDF] January 25, 2019


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Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03988829     History of Changes
Other Study ID Numbers: IRB 19-112
1R56AG060052-01 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
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 The University of Texas at Dallas:
randomized control trial
cognitive training
simulation games
improving brain function
improving cognition
functional magnetic resonance imaging