NCT05924490

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
Last Updated

June 29, 2023

Status Verified

May 1, 2021

Enrollment Period

5.2 years

First QC Date

May 7, 2021

Last Update Submit

June 20, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    9-11 weeks

  • Immediate change in brain activations during executive functions: multi-tasking

    Change in fMRI brain activations from baseline to post-training.

    9-11 weeks

  • Immediate change in brain activations during executive functions: working memory updating

    Change in fMRI brain activations from baseline to post-training.

    9-11 weeks

Secondary Outcomes (3)

  • Immediate change in the composite score of working memory capacity

    9-11 weeks

  • Immediate change in the fluid reasoning measure

    9-11 weeks

  • immediate change in the composite score of cognition

    9-11 weeks

Other Outcomes (1)

  • Immediate change in the processing speed construct

    9-11 weeks

Study Arms (2)

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.

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.

Behavioral: Semantic Knowledge training

Interventions

Rise of Nation is a complex strategy-based video game, in which individualized-adaptive feedbacks are constantly given to players based on their performance.

Real-time strategy-based videogame training

Packages of various cross-word puzzles include word search, word ladder, and word wheel.

Crystallized intelligence training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Vital Longevity (UT Dallas)

Dallas, Texas, 75235, United States

Location

Study Officials

  • Chandramallika Basak, Ph.D.

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

June 29, 2023

Study Start

January 31, 2013

Primary Completion

April 1, 2018

Study Completion

October 1, 2018

Last Updated

June 29, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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.

Locations