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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796508
Other study ID # PSI2013-41409R
Secondary ID
Status Completed
Phase N/A
First received May 12, 2016
Last updated October 27, 2017
Start date September 2015
Est. completion date September 30, 2017

Study information

Verified date October 2017
Source Universidad Nacional de Educación a Distancia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 84 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental: Non-action video game training
PSI2013-41409R. Effects of video game training on behavioral and neuroimaging measures of attention and memory
Active Comparator: Non-cognitive video game training
16 training sessions with The Sims over 8-10 weeks in small groups

Locations

Country Name City State
Spain Department of Basic Psychology II (UNED) Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Nacional de Educación a Distancia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ballesteros S, Mayas J, Ruiz-Marquez E, Prieto A, Toril P, Ponce de Leon L, de Ceballos ML, Reales Avilés JM. Effects of Video Game Training on Behavioral and Electrophysiological Measures of Attention and Memory: Protocol for a Randomized Controlled Tria — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks
Primary 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 Change from Baseline oddball task at 15 weeks and 30 weeks
Primary 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 Change from Baseline N-back task at 15 weeks and 30 weeks
Primary 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 Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks
Secondary 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. Change from the first training session to the last (16th) training session, up to 12 weeks
Secondary Level of motivation assessed with a questionnaire 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.
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