A pilot randomized controlled trial using EEG-based brain–computer interface training for a Chinese-speaking group of healthy elderly

Figures & data

Figure 1 CONSORT flow diagram.

Abbreviations: BCI, brain–computer interface; ITT, intention-to-treat.

Table 1 Descriptive summary of responses to all items in the usability and acceptability questionnaire

Questionnaire item	Mean (SD)	Median (range)
1. Overall, I am satisfied with how easy it is to use this device	6.7 (0.7)	7 (4–7)
2. I feel comfortable using this device	6.4 (0.7)	7 (5–7)
3. I enjoyed playing the game	6.7 (0.7)	7 (4–7)
4. I think the device is useful in training my memory and attention	6.6 (0.8)	7 (4–7)
5. I will recommend this device to my friends and family	6.5 (0.8)	7 (4–7)
6. Overall, I am satisfied with the interface of the game	6.6 (0.8)	7 (3–7)
7. Overall, I am satisfied with the whole system	6.6 (0.7)	7 (4–7)

Abbreviation: SD, standard deviation.

Table 2 Adverse event form

Item on form	Response options
Adverse event	1= fatigue, 2= seizures, 3= syncope/dizziness, 4= sweating, 5= nausea, 6= headache, 7= others
Status	0= absent, 1= present, 2= NA
CTCAE grade	1= grade 1 (mild), 2= grade 2 (moderate), 3= grade 3 (severe), 4= grade 4 (life-threatening), 5= grade 5 (death)
Date of onset	DD/MM/YYYY
Date stopped (if applicable)	DD/MM/YYYY
Outcome	1= recovered/resolved, 2= recovered/resolved with sequelae, 3= not recovered/not resolved, 4= fatal
Relationship	1= none, 2= unlikely, 3= possible, 4= probable, 5= definite, 6= unknown, 7= NA
Action taken with study treatment	1= none, 2= discontinued, 3= interrupted, 4= modified, 5= interrupted and modified, 6= not applicable
Medication used to treat this adverse event?	Y/N
Serious adverse event?	Y/N

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable; Y, yes; N, no; DD, day; MM, month; YYYY, year.

Table 3 AEs reported and their characteristics

	Number of subjects (N=33)	Number of events
Participants who ever experienced any AE	10 (30.3)	16
Type of AE reported
Fatigue	3 (9.1)	3
Headache	4 (12.1)	5
Others	2 (6.1)	3a
Syncope/dizziness	4 (12.1)	5
Severity, n (%)
Mild	10 (30.3)	15
Moderate	1 (3.0)	1
Relationship, n (%)
None	1 (3.0)	1
Unlikely	3 (9.1)	6
Possible	5 (15.2)	5
Probable	2 (6.1)	3
Unknown	1 (3.0)	1
Medication used to treat this AE?, n (%)
No	10 (30.3)	16
Outcome, n (%)
Recovered/resolved	9 (27.3)	15
Not recovered/not resolved	1 (3.0)	1
Action taken to study treatment, n (%)
None	9 (27.3)	15
Interrupted	1 (3.0)	1

Note:

a The three events reported were: “discomfort in the head but not headache” from one subject, and two reports of “eye pain, tearing” from another subject.

Abbreviation: AE, adverse event.

Table 4 A comparison of change in RBANS domain and total scale index scores between Weeks 1 and 8 for the intervention and waitlist control arms

Change in RBANS scores between Weeks 1 and 8	Intervention (n=20)	Waitlist (n=16)	P-valuea	Median difference (95% CI)b
RBANS domain index scores
Immediate memory
Mean (SD)	5.7 (14.3)	−2.3 (15.9)
Median (range)	3.5 (−22 to 29)	0.0 (−32 to 26)	0.129	7.0 (−3.0, 20.0)
Visuospatial/constructional
Mean (SD)	4.8 (12.9)	−1.3 (10.4)
Median (range)	5.0 (−17 to 44)	0.0 (−27 to 17)	0.082	6.0 (0.0, 11.0)
Language
Mean (SD)	0.3 (16.2)	−1.4 (16.1)
Median (range)	−1.0 (−24 to 36)	0.0 (−39 to 25)	1.000	0.0 (−10.0, 11.0)
Attention
Mean (SD)	4.1 (10.2)	−0.5 (7.2)
Median (range)	3.0 (−9 to 34)	0.0 (−10 to 21)	0.127	−4.0 (−10.0, 1.0)
Delayed memory
Mean (SD)	3.0 (9.9)	−6.4 (11.5)
Median (range)	0.0 (−19 to 24)	−2.5 (−24 to 9)	0.042	8.0 (0.0, 17.0)
RBANS total scale index score
Mean (SD)	5.5 (11.8)	−3.5 (8.8)
Median (range)	0.5 (−10 to 29)	−1.0 (−20 to 13)	0.042	8.0 (0.0, 16.0)

Notes:

a P-value from the Mann–Whitney U-test

b Hodges–Lehmann estimation and its associated 95% CI.

Abbreviations: CI, confidence interval; RBANS, Repeatable Battery for the Assessment of Neuropsychological Status; SD, standard deviation.

Table 5 Changes in RBANS domain and total scale index scores between pre- and post-intervention, pooling data from the intervention and waitlist control groups

Change in RBANS scores between Weeks 1 and 8	Summary statistics (n=36)	P-valuea
RBANS domain index scores
Immediate memory
Mean (SD)	4.1 (16.0)
Median (range)	1.5 (−23 to 39)	0.126
Visuospatial/constructional
Mean (SD)	1.7 (11.3)
Median (range)	0.0 (−19 to 44)	0.462
Language
Mean (SD)	0.22 (16.6)
Median (range)	0.0 (−45 to 36)	0.984
Attention
Mean (SD)	4.1 (9.3)
Median (range)	1.5 (−12 to 34)	0.008
Delayed memory
Mean (SD)	3.1 (9.1)
Median (range)	0.0 (−19 to 24)	0.039
RBANS total scale index score
Mean (SD)	4.1 (10.4)
Median (range)	1.0 (−15 to 29)	0.039

Note:

a P-value from Wilcoxon signed-rank test.

Abbreviations: RBANS, Repeatable Battery for the Assessment of Neuropsychological Status; SD, standard deviation.