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临床试验/NCT02796508
NCT02796508已完成不适用

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

Universidad Nacional de Educación a Distancia2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
N-BACK

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Non-action video game training

Experimental

Experimental: Non-action video game training 16 1-hour training sessions with 10 non-action video game training selected games from Lumosity.

干预措施: Experimental: Non-action video game training (Behavioral)

Non-cognitive video game training

Active Comparator

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.

干预措施: Active Comparator: Non-cognitive video game training (Behavioral)

结局指标

主要结局

N-BACK

时间窗: 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

CORSI BLOCK

时间窗: 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

STROOP-Negative Priming

时间窗: 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

ODDBALL

时间窗: 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

次要结局

  • Level of motivation assessed with a questionnaire(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.)
  • 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.(Change from the first training session to the last (16th) training session, up to 12 weeks)

研究者

发起方
Universidad Nacional de Educación a Distancia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soledad Ballesteros

Professor

Universidad Nacional de Educación a Distancia

研究点 (2)

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