Clinical trial NCT04439591: Evaluation of Implementation and Effectiveness of Computerised Brain Training for Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Keywords: Computerised cognitive training
Healthy older adults
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Neeuro Pte Ltd
First posted: 2020-06-19
Enrollment: 94
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Self-reported presence of vertigo
* Visual acuity of less than 20/80
* Currently using psychotropic medications

Primary outcomes:
measure: Change in cognition from baseline at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in attention from baseline at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in balance from baseline at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in walking gait from baseline at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Geriatric Education and Research Institute
Study officials:
affiliation: Geriatric Education and Research Institute
name: Shiou Liang Wee, PhD
role: PRINCIPAL_INVESTIGATOR
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