A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy

Tih-Shih Lee, Siau Juinn Alexa Goh, Shin Yi Quek, Rachel Phillips, Cuntai Guan, Yin Bun Cheung, Lei Feng, Stephanie Sze Wei Teng, Chuan Chu Wang, Zheng Yang Chin, Haihong Zhang, Tze Pin Ng, Jimmy Lee, Richard Keefe, K Ranga Rama Krishnan, Tih-Shih Lee, Siau Juinn Alexa Goh, Shin Yi Quek, Rachel Phillips, Cuntai Guan, Yin Bun Cheung, Lei Feng, Stephanie Sze Wei Teng, Chuan Chu Wang, Zheng Yang Chin, Haihong Zhang, Tze Pin Ng, Jimmy Lee, Richard Keefe, K Ranga Rama Krishnan

Abstract

Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI) training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15) and waitlist control arms (n = 16). Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon's randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001). Specifically, there were significant improvements in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. Our BCI-based system shows promise in improving memory and attention in healthy elderly, and appears to be safe, user-friendly and acceptable to senior users. Given the efficacy signal, a phase III trial is warranted.

Trial registration: ClinicalTrials.gov NCT01661894.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. CONSORT flow diagram.
Figure 1. CONSORT flow diagram.
Figure 2. A model engaged in the…
Figure 2. A model engaged in the Brain Computer Interface (BCI) memory and attention training game system.
The model has given written informed consent, as outlined in the PLOS consent form, to publication of her photograph.
Figure 3. Plot of observed RBANS median…
Figure 3. Plot of observed RBANS median total score over time by treatment arm.

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