NCT02007616

Brief Summary

The ageing of the population will inevitably lead to a growing number of older people living alone and in need of care. Given the high cost of geriatric care, a critical research issue is exploring ways to improve or maintain cognitive and functional status in old age. Unfortunately, it has been shown that training those specific cognitive processes most sensitive to ageing (such as speed of processing or working memory), produces only limited beneficial effects. However, research also suggests that factors such as cognitive engagement, physical activity and social context may act as more general modulators of cognitive decline. This project is a longitudinal study with experimental and control groups. It is inspired from the engagement model of cognitive optimization suggesting that a lifestyle marked by social and intellectual engagement may mitigate age-related declines on cognitive functioning. It uses new cutting-edge information computing technology (ICT) solutions to improve or simply maintain cognitive functions in the elderly. This research investigates how the treatment reduces the effects of cognitive age-related decline in executive control processes and episodic (explicit) memory using behavioral and imaging measures. The results will provide significant knowledge on the potential of new ICT technologies to delay, compensate, and even prevent common chronic problems experienced by the elderly population. The hypothesis is that cognitive training with video-games through ICT solutions will promote brain and mental health and independence. Ultimately, the objective is to contribute to the understanding of factors that help avoiding the (personal and economic) consequences of long-term care in geriatric institutions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

December 4, 2013

Last Update Submit

May 27, 2015

Conditions

AgingHealthy

Keywords

Cognitive agingVideo games trainingAttentionMemoryWellbeingSpeed of processingExecutive functions

Outcome Measures

Primary Outcomes (5)

  • Neuropsychological testing

    Improvement in Neuropsychological tests after training

    Baseline, 12 weeks, and 24 weeks

  • Oddball task

    Improvement in attention after training

    Baseline, 12 weeks, and 24 weeks

  • Wisconsin task

    Improvement in executive functions

    Baseline, 12 weeks, and 24 weeks

  • Speed of processing task

    Improvement in processing speed after training

    Baseline, 12 weeks, and 24 weeks

  • Spatial working memory (WM)

    Improvement in spatial working memory

    Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (1)

  • Efficacy of non-action video game training

    Up to 12 weeks

Study Arms (2)

Non-action video game training

EXPERIMENTAL

20 1-hour sessions of non-action video game training

Other: Non-action video game training

Control

NO INTERVENTION

Participants in the control group did not receive non-action video game training

Interventions

Non-action video game trainingOTHER

Based on cognitive training Lumosity

Non-action video game training

Eligibility Criteria

Age57 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of dementia
  • Planned move from study area
  • Inability to complete study activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Psicología de la UNED

Madrid, Madrid, 28040, Spain

Location

Related Publications (2)

  • Ballesteros S, Mayas J, Prieto A, Toril P, Pita C, Laura Pde L, Reales JM, Waterworth JA. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up. Front Aging Neurosci. 2015 Apr 14;7:45. doi: 10.3389/fnagi.2015.00045. eCollection 2015.

    PMID: 25926790DERIVED

  • Mayas J, Parmentier FB, Andres P, Ballesteros S. Plasticity of attentional functions in older adults after non-action video game training: a randomized controlled trial. PLoS One. 2014 Mar 19;9(3):e92269. doi: 10.1371/journal.pone.0092269. eCollection 2014.

    PMID: 24647551DERIVED

Related Links

Study Officials

  • Soledad Ballesteros, PhD

    UNED

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 11, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

ES(1)