Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jun 16, 2025
Date Accepted: Dec 4, 2025
Efficacy of Brain-Computer Interface Therapy for Upper Limb Rehabilitation in Chronic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
ABSTRACT
Background:
Upper limb dysfunction persists in over 50% of chronic stroke patients despite conventional rehabilitation. Brain-computer interface (BCI) therapy, creating a sensorimotor loop via neural signal-driven feedback, is a promising alternative.
Objective:
To evaluate the efficacy of BCI therapy on upper limb motor function, muscle tone, and activities of daily living in chronic stroke patients, identify optimal BCI feedback modalities and intervention intensity parameters, and explore effective treatment protocols through a meta-analysis of randomized controlled trials.
Methods:
This meta-analysis evaluated BCI efficacy using 21 randomized controlled trials (RCTs) involving chronic stroke patients. Outcomes included upper limb motor function (FMA-UE, ARAT), muscle tone (MAS), and activities of daily living (MBI, MAL). Subgroup analyses explored feedback modalities (BCI-FES, BCI-robot, BCI-visual), intervention intensity (session duration, frequency, total duration/sessions), and follow-up effects.
Results:
BCI significantly improved FMA-UE [MD=1.36, 95%CI(0.18,2.54), p=0.02], MBI [MD=0.63, 95%CI(0.23,1.02), p=0.002], and MAL [MD=0.52, 95%CI(0.18,0.85), p=0.002] versus controls. No significant effects were found for MAS or ARAT. BCI-FES showed superior FMA-UE gains (p=0.004). Optimal intensity was 30-minute sessions, 4–5 times/week for 2 weeks (10–12 sessions total). Benefits did not persist significantly beyond the intervention period.
Conclusions:
BCI training demonstrates promising potential for enhancing upper limb motor function and activities of daily living in patients with chronic stroke. However, evidence regarding its efficacy for improving muscle tone and fine motor skills remains insufficient. Based on current evidence, a preliminary suggested protocol involves BCI-FES training administered for 30 minutes per session, 4 to 5 sessions per week, over a 2-week period. Clinical Trial: CRD420251063808
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