Functional Magnetic Resonance Imaging Clinical Trial
— ViCTOROfficial title:
Strategic Training to Optimize Neurocognitive Functions in Older Adults
Verified date | November 2020 |
Source | The University of Texas at Dallas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Vital Longevity (UT Dallas) | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas at Dallas | National Institute on Aging (NIA), University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Immediate Change in the Composite Score of Reasoning | Change in composite score of Reasoning from baseline to post-training (i.e., after 8 weeks of training). The composite score of reasoning will include correct responses from 2 tasks:
Matrix Reasoning Visual Puzzle For all tasks, alternative forms will be used for baseline testing and for post-training. |
9-10 weeks (includes baseline assessment, training, and post-training assessment) | |
Other | Immediate Change in the Composite Score of Working Memory Capacity | Change in composite score of Working Memory Capacity from baseline to post-training (i.e., after 8 weeks of training). The composite score of working memory capacity will include correct responses from 2 tasks:
List Sorting Working Memory Complex Span For all tasks, alternative forms will be used for baseline testing and for post-training. |
9-10 weeks (includes baseline assessment, training, and post-training assessment) | |
Other | 6-month Change in the Composite Score of Reasoning | Change in composite score of Reasoning from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of reasoning will include correct responses from 2 tasks:
Matrix Reasoning Visual Puzzle For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training. |
8 months (=6 mo of retention + 9-10 weeks) | |
Other | 6-month Change in the Composite Score of Working Memory Capacity | Change in composite score of Working Memory Capacity from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of working memory capacity will include correct responses from 2 tasks:
List Sorting Working Memory Complex Span For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training. |
8 months (=6 mo of retention + 9-10 weeks) | |
Other | Immediate Change in the Composite Score of Psychosocial Functioning - MIDUS-II | Change in composite score of Psychosocial Functioning from baseline to post-training (i.e., after 8 weeks of training). The composite score of psychosocial functioning will include correct responses from 4 tasks:
MIDUS-II Cognitive Reserve Index Rivermead Behavioral Memory Test - III New general Self-efficacy Scale For all tasks, alternative forms will be used for baseline testing and for post-training. |
9-10 weeks (includes baseline assessment, training, and post-training assessment) | |
Other | 6-month Change in the Composite Score of Psychosocial Functioning - MIDUS-II | Change in composite score of Psychosocial Functioning from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of psychosocial functioning will include correct responses from 4 tasks:
MIDUS-II Cognitive Reserve Index Rivermead Behavioral Memory Test - III New general Self-efficacy Scale For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training. |
8 months (=6 mo of retention + 9-10 weeks) | |
Other | Immediate Change in Processing Speed | 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 weeks of training).
Alternative forms will be used for baseline testing and for post-training. |
9-10 weeks (includes baseline assessment, training, and post-training assessment) | |
Other | 6-month Change in Processing Speed | 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 weeks of training).
Alternative forms will be used for baseline testing and at 6-months after completion of training. |
8 months (=6 mo of retention + 9-10 weeks) | |
Primary | Immediate Change in the Composite Score of Episodic Memory | Change in composite score of episodic memory from baseline to post-training (i.e., after 8 weeks of training). The composite score of episodic memory will include correct responses from 3 episodic memory tasks:
Picture Sequence Memory Rey Auditory Verbal Learning Test (RAVLT) 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: Participants are asked to reproduce a sequence of pictures that is shown on the screen. Fifteen words are read to participants. Immediately after, the participant is asked to recall the entire list. This is repeated a few times. A short story is read to participant. Immediately after, the participant is asked to repeat the story. |
9-10 weeks (includes baseline assessment, training, and post-training assessment) | |
Primary | 6-month Change in the Composite Score of Episodic Memory | Change in composite score of episodic memory from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of episodic memory will include correct responses from 3 episodic memory tasks:
Picture Sequence Memory RAVLT Story Recall (MMSE) |
8 months (=6 mo of retention + 9-10 weeks) | |
Secondary | Immediate Change in the Composite Score of Executive Control | Change in composite score of episodic memory from baseline to post-training (i.e., after 8 weeks of training). The composite score of executive control will include correct responses from 6 tasks:
Task Switching Response Time (RT) Dimensional Change Accuracy Flanker RT Stroop RT Visual N-back RT Verbal Memory Updating Accuracy For all tasks, alternative forms will be used for baseline testing and for post-training. |
9-10 weeks (includes baseline assessment, training, and post-training assessment) | |
Secondary | 6-month Change in the Composite Score of Executive Control | Change in composite score of executive control from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of executive control will include correct responses from 6 tasks:
Task Switching RT Dimensional Change Accuracy Flanker RT Stroop RT Visual N-back RT Verbal Memory Updating Accuracy Alternate forms will be used at baseline and at 6-months after completion of training. |
8 months (=6 mo of retention + 9-10 weeks) |
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