NCT02796508

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. 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. 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. 3.to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in saliva from participants underlying cognitive training-induced effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

May 12, 2016

Last Update Submit

October 27, 2017

Conditions

Keywords

Healthy agingCognitive trainingVideo-gamesAttentionWorking memoryWellbeing

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • 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

  • 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.

Study Arms (2)

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.

Behavioral: Experimental: Non-action video game training

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.

Behavioral: Active Comparator: Non-cognitive video game training

Interventions

PSI2013-41409R. Effects of video game training on behavioral and neuroimaging measures of attention and memory

Also known as: 16 training session with Lumosity over 8-10 weeks in small groups
Non-action video game training

16 training sessions with The Sims over 8-10 weeks in small groups

Also known as: Social video game training
Non-cognitive video game training

Eligibility Criteria

Age55 Years - 84 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
  • Communication problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Basic Psychology II (UNED)

Madrid, 28040, Spain

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Soledad Ballesteros, Ph.D.

    Departament of Basic Psychology II, Universidad Nacional de Educación a Distancia (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

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 10, 2016

Study Start

September 1, 2015

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations