Age-related Cognitive DeclineNCT05924490
Cognitive Engagement and Aging Mind
A study testing Real-time strategy-based videogame training and Semantic Knowledge training in people with Age-related Cognitive Decline, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Real-time strategy-based videogame training and Semantic Knowledge training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2013to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Left-handed or ambidextrous
- younger than 50
- cannot distinguish colors during color blindness test
- claustrophobia
- metal artifact in body
- over 300 lb
Show all 11Show fewer
- pacemaker
- MMSE score lower than 24
- history of stroke
- history of substance or alcohol abuse
- currently taking anti-psychotic or anti-depression medication
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Vital Longevity (UT Dallas)
Dallas, Texas, 75235
About this study
Official title: 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.
Read the 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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Real-time strategy-based videogame training, Semantic Knowledge training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time strategy-based videogame trainingBehavioural
Rise of Nation is a complex strategy-based video game, in which individualized-adaptive feedbacks are constantly given to players based on their performance.
Semantic Knowledge trainingBehavioural
Packages of various cross-word puzzles include word search, word ladder, and word wheel.
| Study group | Role | What they receive |
|---|---|---|
| Real-time strategy-based videogame training | Experimental | 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. Receives: Behavioral: Real-time strategy-based videogame training |
| Crystallized intelligence training | Active comparator | 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. Receives: Behavioral: Semantic Knowledge training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in the composite score of executive functions
Change in the composite score of executive functions, and its subcomponents, from baseline to post-training. Higher change in score represents better outcome.
Measured: 9-11 weeks
Immediate change in the composite score of episodic memory
Change in the composite score of episodic memory from baseline to post-training.Higher change in score represents better outcome.
Measured: 9-11 weeks
Immediate change in brain activations during executive functions: multi-tasking
Change in fMRI brain activations from baseline to post-training.
Measured: 9-11 weeks
Immediate change in brain activations during executive functions: working memory updating
Change in fMRI brain activations from baseline to post-training.
Measured: 9-11 weeks
Secondary outcomes (3)
Immediate change in the composite score of working memory capacity
Change in the composite score of working memory capacity from baseline to post-training.Higher change in score represents better outcome.
Measured: 9-11 weeks
Immediate change in the fluid reasoning measure
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.
Measured: 9-11 weeks
immediate change in the composite score of cognition
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.
Measured: 9-11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start31 Jan 2013
- Primary completion1 Apr 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chandramallika Basak, Ph.D., Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924490
- Sponsor's protocol ID
- IRB 12-57
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05924490
- Acronym / sponsor ID
- IRB 12-57
- Conditions
- Age-related Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 31 Jan 2013 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time strategy-based videogame training | Experimental | Behavioral: Real-time strategy-based videogame trainingParticipants 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. |
| Crystallized intelligence training | Active comparator | Behavioral: Semantic Knowledge trainingParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Right-handed
- over 50 Years of Age
- native or fluent English speaker
- not Color-blind
- Magnetic Resonance Imaging eligible
Key exclusion criteria (11 listed)
- Left-handed or ambidextrous
- younger than 50
- cannot distinguish colors during color blindness test
- claustrophobia
- metal artifact in body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time strategy-based videogame trainingRise of Nation is a complex strategy-based video game, in which individualized-adaptive feedbacks are constantly given to players based on their performance. | Behavioural | Real-time strategy-based videogame training |
| Semantic Knowledge trainingPackages of various cross-word puzzles include word search, word ladder, and word wheel. | Behavioural | Crystallized intelligence training |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Immediate change in the composite score of working memory capacity
Time frame: 9-11 weeks
Immediate change in the fluid reasoning measure
Time frame: 9-11 weeks
immediate change in the composite score of cognition
Time frame: 9-11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandramallika Basak, Ph.D. principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time strategy-based videogame training and Semantic Knowledge training in people with Age-related Cognitive Decline, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate change in the composite score of executive functions (time frame: 9-11 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.