AgingNCT02007616
Cognitive Aging and Training With Video-games
A study testing Non-action video game training in people with Aging and Healthy, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 57 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Non-action video game training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 57 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of dementia
- Planned move from study area
- Inability to complete study activities
- Scores lower than inclusion criteria requirements Communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compensation Factors of Cognitive Ageing: Using Computer Technology to Reduce Cognitive Decline in Ageing
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.
Read the detailed description
The aim of the present project was to investigate whether older adults could benefit from brain training with video games in a series of cognitive tasks. Two groups of healthy older adults participated in the study. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity) involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the training (experimental group) or a similar period of time (control group) using different cognitive tasks in a 2 (Group: Experimental, control) x 2 (Time os assessment: Pre, post) mixed factorial design.
- Being tested
- Non-action video game training
- Keywords
- Cognitive aging, Video games training, Attention, Memory, Wellbeing, Speed of processing, Executive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-action video game trainingOther
Based on cognitive training Lumosity
| Study group | Role | What they receive |
|---|---|---|
| Non-action video game training | Experimental | 20 1-hour sessions of non-action video game training Receives: Other: Non-action video game training |
| Control | No intervention | Participants in the control group did not receive non-action video game training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological testing
Improvement in Neuropsychological tests after training
Measured: Baseline, 12 weeks, and 24 weeks
Oddball task
Improvement in attention after training
Measured: Baseline, 12 weeks, and 24 weeks
Wisconsin task
Improvement in executive functions
Measured: Baseline, 12 weeks, and 24 weeks
Speed of processing task
Improvement in processing speed after training
Measured: Baseline, 12 weeks, and 24 weeks
Spatial working memory (WM)
Improvement in spatial working memory
Measured: Baseline, 12 weeks, and 24 weeks
Secondary outcomes (1)
Efficacy of non-action video game training
Efficacy of training: Better performance in the trained video games from first training session to the last training session (from 1 to 20 sessions)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soledad Ballesteros, Universidad Nacional de Educación a Distancia
- Investigators
- Soledad Ballesteros, PhD, Principal investigator, UNED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007616
- Sponsor's protocol ID
- PSI2010-21609-C02-01
- Status last verified
- May 2015
- First submitted
- 4 Dec 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25926790Mayas 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.
PubMed 24647551
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensation Factors of Cognitive Ageing: Using Computer Technology to Reduce Cognitive Decline in Ageing
- ClinicalTrials.gov ID
- NCT02007616
- Acronym / sponsor ID
- PSI2010-21609-C02-01
- Keywords
- Cognitive aging, Video games training, Attention, Memory, Wellbeing, Speed of processing, Executive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the present project was to investigate whether older adults could benefit from brain training with video games in a series of cognitive tasks. Two groups of healthy older adults participated in the study. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity) involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the training (experimental group) or a similar period of time (control group) using different cognitive tasks in a 2 (Group: Experimental, control) x 2 (Time os assessment: Pre, post) mixed factorial design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-action video game training | Experimental | Other: Non-action video game training20 1-hour sessions of non-action video game training |
| Control | No intervention | –Participants in the control group did not receive non-action video game training |
Who may qualify
- Ages
- 57 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosis of dementia
- Planned move from study area
- Inability to complete study activities
- Scores lower than inclusion criteria requirements Communication problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-action video game trainingBased on cognitive training Lumosity | Other | Non-action video game training |
Primary outcome
Neuropsychological testing
Time frame: Baseline, 12 weeks, and 24 weeks
Improvement in Neuropsychological tests after training
Oddball task
Time frame: Baseline, 12 weeks, and 24 weeks
Improvement in attention after training
Wisconsin task
Time frame: Baseline, 12 weeks, and 24 weeks
Improvement in executive functions
Speed of processing task
Time frame: Baseline, 12 weeks, and 24 weeks
Improvement in processing speed after training
Spatial working memory (WM)
Time frame: Baseline, 12 weeks, and 24 weeks
Improvement in spatial working memory
1 secondary outcome
Efficacy of non-action video game training
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 25926790Ballesteros 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.
- Derived from this study: PubMed 24647551Mayas 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.
- Web of the Research Group on Studies on Aging and Neurodegenerative DiseasesLink provided by the sponsor.
- Web of the Universidad Nacional de Educación a DistanciaLink provided by the sponsor.
- Lumosity websiteLink provided by the sponsor.
- PlosOne websiteLink provided by the sponsor.
- Frontiers websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soledad Ballesteros, PhD principal investigator
UNED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-action video game training in people with Aging and Healthy, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological testing (time frame: Baseline, 12 weeks, and 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.