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AgeingAGEGAMENCT02796508

Attention and Memory Training With Video Games in Old Age

A study testing Experimental: Non-action video game training and Active Comparator: Non-cognitive video game training in people with Ageing, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 to 84 yearsHealthy volunteers can take part
Conditions the study is for
Ageing
What is being tested?
Experimental: Non-action video game training and Active Comparator: Non-cognitive video game training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
Sep 2015to 30 Sep 2017
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 55 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Basic Psychology II (UNED)

    Madrid, 28040

Other trials in Spain

About this study

Official title: 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.

Conditions
Ageing
Being tested
Experimental: Non-action video game training, Active Comparator: Non-cognitive video game training
Keywords
Healthy aging, Cognitive training, Video-games, Attention, Working memory, Wellbeing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Non-action video game trainingBehavioural

    Also called 16 training session with Lumosity over 8-10 weeks in small groups

    PSI2013-41409R. Effects of video game training on behavioral and neuroimaging measures of attention and memory

  • Active Comparator: Non-cognitive video game trainingBehavioural

    Also called Social video game training

    16 training sessions with The Sims over 8-10 weeks in small groups

Study groups in NCT02796508
Study groupRoleWhat they receive
Non-action video game trainingExperimentalExperimental: Non-action video game training 16 1-hour training sessions with 10 non-action video game training selected games from Lumosity.
Receives: Behavioral: Experimental: Non-action video game training
Non-cognitive video game trainingActive comparatorActive Control: Non-cognitive social video game training 16 1-hour training sessions with non-cognitive video game training with social games from The Sims.
Receives: Behavioral: Active Comparator: Non-cognitive video game training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. STROOP-Negative Priming

    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

    Measured: Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks

  2. ODDBALL

    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

    Measured: Change from Baseline oddball task at 15 weeks and 30 weeks

  3. N-BACK

    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

    Measured: Change from Baseline N-back task at 15 weeks and 30 weeks

  4. CORSI BLOCK

    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

    Measured: Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks

Secondary outcomes (2)

  1. 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.

    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.

    Measured: Change from the first training session to the last (16th) training session, up to 12 weeks

  2. Level of motivation assessed with a questionnaire

    Maintenance of motivation from the first to the last training sessions

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2016 (estimated)
  2. Study startSep 2015
  3. Primary completion30 Sep 2017
  4. Study completion30 Sep 2017

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02796508
Sponsor's protocol ID
PSI2013-41409R
Acronym
AGEGAME
Status last verified
Oct 2017
First submitted
12 May 2016
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Ballesteros S, Mayas J, Ruiz-Marquez E, Prieto A, Toril P, Ponce de Leon L, de Ceballos ML, Reales Aviles JM. Effects of Video Game Training on Behavioral and Electrophysiological Measures of Attention and Memory: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Jan 24;6(1):e8. doi: 10.2196/resprot.6570.

    PubMed 28119279

  • Ballesteros S, Mayas J, Prieto A, Ruiz-Marquez E, Toril P, Reales JM. Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial. Front Aging Neurosci. 2017 Nov 1;9:354. doi: 10.3389/fnagi.2017.00354. eCollection 2017.

    PubMed 29163136

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Non-action video game training and Active Comparator: Non-cognitive video game training in people with Ageing, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

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 4 inclusion and 5 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 30 Oct 2017. 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 Spain. 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?

STROOP-Negative Priming (time frame: Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 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?

On the ClinicalTrials.gov record for NCT02796508, which also lists 2 linked publications.

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 30 Oct 2017; AzTrials last refreshed its copy on 2 Nov 2026.

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