Clinical trial NCT02796508: Attention and Memory Training With Video Games in Old Age
Official title: Age-related Cognitive Decline: Effects of Video Game Training on Behavioral and Neuroimaging Measures of Attention and Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Keywords: Healthy aging
Cognitive training
Video-games
Attention
Working memory
Wellbeing
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 75
Sex: ALL
Minimum age (years): 55
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: STROOP-Negative Priming
timeFrame: Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks
measure: ODDBALL
timeFrame: Change from Baseline oddball task at 15 weeks and 30 weeks
measure: N-BACK
timeFrame: Change from Baseline N-back task at 15 weeks and 30 weeks
measure: CORSI BLOCK
timeFrame: Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks
Secondary outcomes:
measure: 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.
timeFrame: Change from the first training session to the last (16th) training session, up to 12 weeks
measure: Level of motivation assessed with a questionnaire
timeFrame: 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.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Basic Psychology II (UNED)
Study officials:
affiliation: Departament of Basic Psychology II, Universidad Nacional de Educación a Distancia (UNED)
name: Soledad Ballesteros, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.