- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924490
Cognitive Engagement and Aging Mind
June 20, 2023 updated by: The University of Texas at Dallas
Cognitive Engagement and Aging Mind: A Randomized Control Trial to Determine the Effects of Adaptive Real-time Strategy Game Training on Cognition and Brain Functions of Older Adults
The purpose of this research is to examine whether and to what extent training of different types of cognitive engagement will improve performance on fluid cognitive abilities that typically decline with age.
The research covered by this protocol will use behavioral data that yield response latencies and accuracies of the untrained tasks, and brain activations in fMRI tasks, to test specific hypotheses about neural plasticity and cognitive plasticity from these engagement techniques.
Hence, human subjects will be employed in an experiment lasting for 20 hours spanning over 2 months where they will either receive real-time strategy-based videogame training or crystallized intelligence training.
In addition, long-term retention data will be obtained after 6 month post-training to investigate any long-term benefits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research is to examine whether and to what extent training of different types of cognitive engagement will improve performance on fluid cognitive abilities that typically decline with age (such as, speed of information processing, working memory capacity, episodic memory, and executive functions).
The research covered by this protocol will use behavioral data that yield response latencies and accuracies of the untrained tasks, and brain activations in fMRI tasks, to test specific hypotheses about the extent of transfer, if any, and the underlying cognitive constructs that may be trained in the process.
Hence, human subjects will be employed in an experiment lasting for 20 hours spanning over 2 months where they will either receive real-time strategy-based videogame training or crystallized intelligence training.
In addition, long-term retention data will be obtained after 6 month post-training to investigate any long-term benefits.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75235
- The Center for Vital Longevity (UT Dallas)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Right-handed
- over 50 Years of Age
- native or fluent English speaker
- not Color-blind
- Magnetic Resonance Imaging eligible
- Mini Mental Status Examination Score >24
Exclusion Criteria:
- Left-handed or ambidextrous
- younger than 50
- cannot distinguish colors during color blindness test
- claustrophobia
- metal artifact in body
- over 300 lb
- pacemaker
- MMSE score lower than 24
- history of stroke
- history of substance or alcohol abuse
- currently taking anti-psychotic or anti-depression medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real-time strategy-based videogame training
Participants played a real-time strategy-based videogame in laboratory setting, Rise of Nations, for 2 hours a day, two days per week, for 5 weeks.
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Rise of Nation is a complex strategy-based video game, in which individualized-adaptive feedbacks are constantly given to players based on their performance.
|
|
Active Comparator: Crystallized intelligence training
Participants completed a series of crossword puzzles each week, for 5-6 weeks.
Training sessions were completed at the participants' home or area of preference.
Participant received a periodic phone call (2 times per week) from research staff to update any notes or details regarding participants' study progress.
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Packages of various cross-word puzzles include word search, word ladder, and word wheel.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate change in the composite score of executive functions
Time Frame: 9-11 weeks
|
Change in the composite score of executive functions, and its subcomponents, from baseline to post-training.
Higher change in score represents better outcome.
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9-11 weeks
|
|
Immediate change in the composite score of episodic memory
Time Frame: 9-11 weeks
|
Change in the composite score of episodic memory from baseline to post-training.Higher change in score represents better outcome.
|
9-11 weeks
|
|
Immediate change in brain activations during executive functions: multi-tasking
Time Frame: 9-11 weeks
|
Change in fMRI brain activations from baseline to post-training.
|
9-11 weeks
|
|
Immediate change in brain activations during executive functions: working memory updating
Time Frame: 9-11 weeks
|
Change in fMRI brain activations from baseline to post-training.
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9-11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate change in the composite score of working memory capacity
Time Frame: 9-11 weeks
|
Change in the composite score of working memory capacity from baseline to post-training.Higher change in score represents better outcome.
|
9-11 weeks
|
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Immediate change in the fluid reasoning measure
Time Frame: 9-11 weeks
|
Change in the fluid reasoning measure (Raven's Advanced Progressive Matrices, a paper and pencil test) from baseline to post-training.
Higher change in score represents better outcome.
|
9-11 weeks
|
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immediate change in the composite score of cognition
Time Frame: 9-11 weeks
|
Change in composite score of cognition from baseline to long-term retention.
Composite score for overall cognition is summed across composite scores for executive function, processing speed, processing speed, working memory capacity and fluid reasoning.
Higher change in score represents better outcome.
|
9-11 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate change in the processing speed construct
Time Frame: 9-11 weeks
|
Change in the processing speed construct from baseline to post-training.
Higher change in score represents better outcome.
|
9-11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chandramallika Basak, Ph.D., The University of Texas at Dallas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2013
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
May 7, 2021
First Submitted That Met QC Criteria
June 20, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 12-57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is not a federally funded data, so no IDP is planned to be shared.
However, all descriptive statistics will be provided in the publications, therefore, all meaningful data for the outcomes will be reported for any future meta-analyses or calculations of effect size.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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