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

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ClinicalTrials.gov Identifier: NCT02796508
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Soledad Ballesteros, Universidad Nacional de Educación a Distancia

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ageing Behavioral: Experimental: Non-action video game training Behavioral: Active Comparator: Non-cognitive video game training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Age-related Cognitive Decline: Effects of Video Game Training on Behavioral and Neuroimaging Measures of Attention and Memory
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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 Name: 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 Name: Social video game training




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  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. [ 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796508


Locations
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Spain
Department of Basic Psychology II (UNED)
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Nacional de Educación a Distancia
Investigators
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Principal Investigator: Soledad Ballesteros, Ph.D. Departament of Basic Psychology II, Universidad Nacional de Educación a Distancia (UNED)

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Soledad Ballesteros, Professor, Universidad Nacional de Educación a Distancia
ClinicalTrials.gov Identifier: NCT02796508     History of Changes
Other Study ID Numbers: PSI2013-41409R
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Soledad Ballesteros, Universidad Nacional de Educación a Distancia:
Healthy aging
Cognitive training
Video-games
Attention
Working memory
Wellbeing