title: A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01661894.
authors.affiliation: Duke-National University of Singapore, Graduate Medical School, Singapore, Singapore.
authors.forename: Tih-Shih
authors.initials: TS
authors.lastname: Lee
authors.forename: Siau Juinn Alexa
authors.initials: SJ
authors.lastname: Goh
authors.forename: Shin Yi
authors.initials: SY
authors.lastname: Quek
authors.forename: Rachel
authors.initials: R
authors.lastname: Phillips
authors.forename: Cuntai
authors.initials: C
authors.lastname: Guan
authors.forename: Yin Bun
authors.initials: YB
authors.lastname: Cheung
authors.forename: Lei
authors.initials: L
authors.lastname: Feng
authors.forename: Stephanie Sze Wei
authors.initials: SS
authors.lastname: Teng
authors.forename: Chuan Chu
authors.initials: CC
authors.lastname: Wang
authors.forename: Zheng Yang
authors.initials: ZY
authors.lastname: Chin
authors.forename: Haihong
authors.initials: H
authors.lastname: Zhang
authors.forename: Tze Pin
authors.initials: TP
authors.lastname: Ng
authors.forename: Jimmy
authors.initials: J
authors.lastname: Lee
authors.forename: Richard
authors.initials: R
authors.lastname: Keefe
authors.forename: K Ranga Rama
authors.initials: KR
authors.lastname: Krishnan
mesh_terms: D000368:Aged; D062207:Brain-Computer Interfaces; D003071:Cognition / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011795:Surveys and Questionnaires