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CognitionNCT04439591

Evaluation of Implementation and Effectiveness of Computerised Brain Training for Older Adults

A study testing Computerised cognitive training in people with Cognition, run by Geriatric Education and Research Institute at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the implementation and effectiveness of a group-based brain-computer interface cognitive training among community dwelling older adults in Singapore. A 12-week bi-weekly programme was conducted in community centres. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Cognition
What is being tested?
Computerised cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteSingapore
Study dates
1 Aug 2017to 9 Nov 2018
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Above or equal to 55 years old
  • Sedentary lifestyle (exercise less than or equal to once week)
  • Literate in English/Chinese
  • Able to travel to study site independently

Who cannot join

  • Had significant cognitive impairment (Mini Mental State Examination score <=23) or presence of known neuropsychiatric disorders
  • Geriatric Depression Scale >9
  • Presence of a severe walking or balance impairments
  • Previously completed a cognitive training program within the last year
  • Color-blindness
  • Plans to begin a balance program during the study period
Show all 9Show fewer
  • Self-reported presence of vertigo
  • Visual acuity of less than 20/80
  • Currently using psychotropic medications

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Geriatric Education and Research Institute

    Singapore, 768024

Other trials in Singapore

About this study

Official title: Group-based Brain-computer Interface (BCI) Cognitive Training in Healthy Older Adults: An Evaluation of Programme Implementation and Effectiveness in Neighborhood Community Centers

This study aims to evaluate the implementation and effectiveness of a group-based brain-computer interface cognitive training among community dwelling older adults in Singapore. A 12-week bi-weekly programme was conducted in community centres. During these sessions, participants played games targeting cognitive domains such as attention, memory, and decision making, using a mobile application (Memorie). Selected games were paired with an electroencephalography headset (Senzeband) which quantified participants' attention level into scores that affected the participants' in-game avatar control or game performance. Each participant paid a subsidized fee of SGD$20 for the programme.

Read the detailed description

There has been emerging interest in research to help older adults maintain cognitive and physical function in old age. There has been evidence that cognitive training can help improve targeted cognitive domains in both typically and atypically aging older people. Cognitive training typically involves structured, frequent and repeated engagement in standardized cognitively demanding tasks targeting specific cognitive domains. There are several potential mechanisms underlying cognitive benefits of cognitive training. As the brain has neural plasticity (which is the lifelong ability for physical and functional change in response to sensing, perceiving and learning), engaging in mentally stimulating activities may stimulate neuroplasticity and thereby increase cognitive reserve. In fact, animal studies have shown that cognitive stimulation can result in molecular, synaptic and neural alterations in the brain. Studies in humans also showed that intervention studies incorporating brain training have reported increased serum levels of brain derived neurotropic factor, a factor that plays an important role in memory processing. Brain imaging studies showed changes in activity in certain brain regions while performing specific tasks, along with long-term global changes following cognitive training. Over the last five years, there has been an increase in research about the effectiveness of CCT. According to a systematic review of the clinical significance of commercially available CCT in preventing cognitive decline in 2016, there have been 18 commercial brain training programs for older people. According to a meta-analysis of 52 studies using commercial CCT programs in 4885 participants, CCT is modestly effective at improving cognitive performance in cognitively healthy older adults, but efficacy varies across cognitive domains and is largely determined by design choices. Unsupervised at-home training and training more than three times per week are specifically ineffective. Small to moderate effect sizes were found for nonverbal memory, g = 0.24 (95% CI 0.09 to 0.38), verbal memory, g = 0.08 (95% CI 0.01 to 0.15), working memory (WM), g = 0.22 (95% CI 0.09 to 0.35), processing speed, g =0.31 (95% CI 0.11 to 0.50), visuospatial skills, g = 0.30 (95% CI 0.07 to 0.54), and no significant effect was found for executive function and attention. In Singapore, two previous randomized control trials also reported the benefits of CCT on improved overall RBANS score in healthy older adults, but the efficacy on targeted cognitive domains (memory, visuospatial, attention) was not consistent among these two studies.

Cognition has a close association with gait and balance. Cognitive impairments, specifically deficits in executive function, have been associated with increased risk of falls, abnormal gait, and other mobility tasks. Gait variability in older people is associated with atrophy in brain regions related to attention function. Global cognitive function, verbal memory, and executive function can predict longitudinal gait speed decline. There has been evidence that cognitive intervention may not only improve various cognitive domains but also improve physical function. As there has been no previously published review on the topic, the researchers conduct a literature search via MEDLINE (to May 2017). Keywords used for searching included "computerized cognitive training", "gait" and "balance". The articles attained by this search method were screened by title and three relevant original studies were retrieved. All of these studies were conducted in the United States. These studies suggested that CCT may improve gait speed and balance in American older people, especially in those with sedentary lifestyle. One such CCT programme in Singapore was developed by Neeuro together with A*STAR and was made commercially available since 2016. Since then, it has been showcased at various events, such as the Silver IT Fest and NextStop Seminar organised by the Future Ready Committee. To date, there has been no assessment on the effectiveness of CCT in cognition, gait and function in the older people in Singapore hence this study will focus on evaluating these parameters. Results from this study may contribute to evidence in the local context.

Conditions
Cognition
Being tested
Computerised cognitive training
Keywords
Computerised cognitive training, Healthy older adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerised cognitive trainingOther

    A 12-week bi-weekly group-based computerised cognitive training programme conducted in community centres

Study groups in NCT04439591
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention group undergoes computerised brain training programme first.
Receives: Other: Computerised cognitive training
Control groupOtherWaitlist control group: control group undergoes programme after intervention group has completed it in a crossover design.
Receives: Other: Computerised cognitive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognition from baseline at 12 weeks

    Repeated Battery for the Assessment of Neuropsychological Status (RBANS). The maximum score that an individual can get is 160, and higher scores indicate better performance. The tests consists of 12 subtests grouped into 5 domains of cognition.

    Measured: Baseline and 12 weeks

  2. Change in attention from baseline at 12 weeks

    Colour Trails Test. Time taken to complete the actual trial was recorded, along with the number of near-misses, prompts, number sequence errors, and color sequence errors.

    Measured: Baseline and 12 weeks

Secondary outcomes (2)
  1. Change in balance from baseline at 12 weeks

    Berg Balance Scale (BBS). BBS provides a measure of balance via performance on 14 functional tasks. Performance for each task was scored independently using a 0 - 4 scale, with higher scores reflecting higher functioning and better balance. Individual task scores were summed to derive a composite score for analyses.

    Measured: Baseline and 12 weeks

  2. Change in walking gait from baseline at 12 weeks

    Portable gait analysis system (GAITRite). The GAITRite measures how a person walks. It measures gait patterns for both time (temporal) and space (spatial) through pressure sensors in the mat. The software changes the information into foot placement patterns and overall gait patterns.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start1 Aug 2017
  3. Primary completion9 Nov 2018
  4. Study completion9 Nov 2018

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04439591
Sponsor's protocol ID
2017/00611
Other IDs
2017
Status last verified
Jun 2020
First submitted
17 Jun 2020
Last updated
22 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to confidentiality issues, IPD will not be published. However, de-identified data will be made available upon request.

Publications

  • Shah TM, Weinborn M, Verdile G, Sohrabi HR, Martins RN. Enhancing Cognitive Functioning in Healthly Older Adults: a Systematic Review of the Clinical Significance of Commercially Available Computerized Cognitive Training in Preventing Cognitive Decline. Neuropsychol Rev. 2017 Mar;27(1):62-80. doi: 10.1007/s11065-016-9338-9. Epub 2017 Jan 14.

    PubMed 28092015
  • Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD003260. doi: 10.1002/14651858.CD003260.pub2.

    PubMed 23740535
  • Raz N, Lindenberger U. Life-span plasticity of the brain and cognition: from questions to evidence and back. Neurosci Biobehav Rev. 2013 Nov;37(9 Pt B):2195-200. doi: 10.1016/j.neubiorev.2013.10.003. Epub 2013 Oct 15.

    PubMed 24140011
  • Buonomano DV, Merzenich MM. Cortical plasticity: from synapses to maps. Annu Rev Neurosci. 1998;21:149-86. doi: 10.1146/annurev.neuro.21.1.149.

    PubMed 9530495
  • Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016.

    PubMed 22261206
  • Vinogradov S, Fisher M, Holland C, Shelly W, Wolkowitz O, Mellon SH. Is serum brain-derived neurotrophic factor a biomarker for cognitive enhancement in schizophrenia? Biol Psychiatry. 2009 Sep 15;66(6):549-53. doi: 10.1016/j.biopsych.2009.02.017. Epub 2009 Apr 15.

    PubMed 19368899
  • Buschert V, Bokde AL, Hampel H. Cognitive intervention in Alzheimer disease. Nat Rev Neurol. 2010 Sep;6(9):508-17. doi: 10.1038/nrneurol.2010.113. Epub 2010 Aug 17.

    PubMed 20717104
  • Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

    PubMed 25405755
  • Lee TS, Goh SJ, Quek SY, Phillips R, Guan C, Cheung YB, Feng L, Teng SS, Wang CC, Chin ZY, Zhang H, Ng TP, Lee J, Keefe R, Krishnan KR. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy. PLoS One. 2013 Nov 18;8(11):e79419. doi: 10.1371/journal.pone.0079419. eCollection 2013.

    PubMed 24260218
  • Lee TS, Quek SY, Goh SJ, Phillips R, Guan C, Cheung YB, Feng L, Wang CC, Chin ZY, Zhang H, Lee J, Ng TP, Krishnan KR. A pilot randomized controlled trial using EEG-based brain-computer interface training for a Chinese-speaking group of healthy elderly. Clin Interv Aging. 2015 Jan 9;10:217-27. doi: 10.2147/CIA.S73955. eCollection 2015.

    PubMed 25624754
  • Muir SW, Gopaul K, Montero Odasso MM. The role of cognitive impairment in fall risk among older adults: a systematic review and meta-analysis. Age Ageing. 2012 May;41(3):299-308. doi: 10.1093/ageing/afs012. Epub 2012 Feb 27.

    PubMed 22374645
  • Holtzer R, Friedman R, Lipton RB, Katz M, Xue X, Verghese J. The relationship between specific cognitive functions and falls in aging. Neuropsychology. 2007 Sep;21(5):540-8. doi: 10.1037/0894-4105.21.5.540.

    PubMed 17784802
  • Kearney FC, Harwood RH, Gladman JR, Lincoln N, Masud T. The relationship between executive function and falls and gait abnormalities in older adults: a systematic review. Dement Geriatr Cogn Disord. 2013;36(1-2):20-35. doi: 10.1159/000350031. Epub 2013 May 23.

    PubMed 23712088
  • Persad CC, Jones JL, Ashton-Miller JA, Alexander NB, Giordani B. Executive function and gait in older adults with cognitive impairment. J Gerontol A Biol Sci Med Sci. 2008 Dec;63(12):1350-5. doi: 10.1093/gerona/63.12.1350.

    PubMed 19126848
  • Rosano C, Brach J, Studenski S, Longstreth WT Jr, Newman AB. Gait variability is associated with subclinical brain vascular abnormalities in high-functioning older adults. Neuroepidemiology. 2007;29(3-4):193-200. doi: 10.1159/000111582. Epub 2007 Nov 27.

    PubMed 18043004

Questions about this trial

What is this clinical trial studying?

A study testing Computerised cognitive training in people with Cognition, run by Geriatric Education and Research Institute at 1 site in Singapore.

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 9 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 22 Jun 2020. 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 Singapore. 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?

Change in cognition from baseline at 12 weeks (time frame: Baseline and 12 weeks). The study lists 2 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 NCT04439591, which also lists 21 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 22 Jun 2020.

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