Attention and Memory Training With Video Games in Old Age (AGEGAME)

October 27, 2017 updated by: Soledad Ballesteros, Universidad Nacional de Educación a Distancia

Age-related Cognitive Decline: Effects of Video Game Training on Behavioral and Neuroimaging Measures of Attention and Memory

Neuroplasticity-based approaches seem very promising to maintain cognitive health in older adults and postpone the onset of cognitive-decline and dementia symptoms. The aims of this project are threefold:

  1. the evaluation of the effects of a neuroplasticity-based-cognitive randomized computer-based intervention consisting in training with non-action video games on brain and cognitive functions that decline with ageing, including attention and spatial working memory (WM), in older adults using behavioral measures and electrophysiological recordings (event-related potentials -ERPs- and event-related spectral perturbations -ERSPs);
  2. the study of the effects of age and 3 months maintenance on the cognitive and neural signatures of transfer effects to attentional and spatial WM tasks; and
  3. to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in saliva from participants underlying cognitive training-induced effects.

A better understanding of these mechanisms elucidates pathways that may be targeted in the future, either by behavioral or neuropsychological interventions. To achieve these aims, the investigators will recruit between 60-80 older adults volunteers to participate in the randomized, controlled, single-blind study. After screening, participants will be randomly distributed in one of these two groups: experimental and active control. Participants in the experimental group will receive 16 1 hour computerized training with non-action video games. The active control group will receive 16 1 hour training sessions with a social video game. The design is a mixed factorial design with type of intervention (experimental, active control) and assessment session (pre, post, maintenance). The results from the proposed research project will clarify the existence of transfer-of-benefit and neural mechanisms underlying cognitive improvement. The hypothesis is that mental stimulation through non-action video games will improve attention and memory, promoting brain and mental health, and extending independence among elderly people by avoiding the negative personal and economic consequences of long-term care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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

  • Spain
      • Madrid, Spain, 28040
        • Department of Basic Psychology II (UNED)

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

55 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mini-Mental State Examination (MMSE) score 26 or greater
  • Global Deterioration Scale (GDS) score less than 5
  • Independent living
  • Normal or correct to normal vision and hearing

Exclusion Criteria:

  • Diagnosis of dementia
  • Planned move from study area
  • Inability to complete study activities
  • Scores lower than inclusion criteria requirements
  • Communication problems.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-action video game training
Experimental: Non-action video game training 16 1-hour training sessions with 10 non-action video game training selected games from Lumosity.
Behavioral: Experimental: Non-action video game training
PSI2013-41409R. Effects of video game training on behavioral and neuroimaging measures of attention and memory
Other Names:
  • 16 training session with Lumosity over 8-10 weeks in small groups
Active Comparator: Non-cognitive video game training
Active Control: Non-cognitive social video game training 16 1-hour training sessions with non-cognitive video game training with social games from The Sims.
Behavioral: Active Comparator: Non-cognitive video game training
16 training sessions with The Sims over 8-10 weeks in small groups
Other Names:
  • Social video game training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STROOP-Negative Priming
Time Frame: Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks
Participants with non-action video-game training, change from baseline in selective attention and capacity to inhibit information on Stroop-Negative Priming task at 15 weeks and maintenance at 30 weeks
Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks
ODDBALL
Time Frame: Change from Baseline oddball task at 15 weeks and 30 weeks
Participants with non-action video-game training, change from baseline in alertness and distraction on Oddball task at 15 weeks and maintenance at 30 weeks
Change from Baseline oddball task at 15 weeks and 30 weeks
N-BACK
Time Frame: Change from Baseline N-back task at 15 weeks and 30 weeks
Participants with non-action video-game training, change from baseline in working memory on N-back task at 15 weeks and maintenance at 30 weeks
Change from Baseline N-back task at 15 weeks and 30 weeks
CORSI BLOCK
Time Frame: Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks
Participants with video-game training, change from baseline in spatial working memory on Corsi block task after at 15 weeks and maintenance at 30 weeks
Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the performance (accuracy scores) obtained on the non-action video games (experimental group) and the non-cognitive video games (active comparator) comparing accuracy scores of the first to the last training session.
Time Frame: Change from the first training session to the last (16th) training session, up to 12 weeks
Efficacy of training: Better performance in the trained video games from first to the last training session comparing accuracy scores of the first to the last training session.
Change from the first training session to the last (16th) training session, up to 12 weeks
Level of motivation assessed with a questionnaire
Time Frame: Maintenance during the 16 training sessions of non-action cognitive video game training and non-cognitive training at first session, 8th and 16th training sessions. Up to 12 weeks.
Maintenance of motivation from the first to the last training sessions
Maintenance during the 16 training sessions of non-action cognitive video game training and non-cognitive training at first session, 8th and 16th training sessions. Up to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Educación a Distancia

Investigators

  • Principal Investigator: Soledad Ballesteros, Ph.D., Departament of Basic Psychology II, Universidad Nacional de Educación a Distancia (UNED)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSI2013-41409R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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