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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • The Center for Vital Longevity (UT Dallas)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Real-time strategy-based videogame training
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.
Behavioral: Semantic Knowledge training
Packages of various cross-word puzzles include word search, word ladder, and word wheel.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
9-11 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas at Dallas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings