A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke.

Electroencephalography (EEG)-based motor imagery (MI) brain-computer interface (BCI) technology has the potential to restore motor function by inducing activity-dependent brain plasticity. The purpose of this study was to investigate the efficacy of an EEG-based MI BCI system coupled with MIT-Manus shoulder-elbow robotic feedback (BCI-Manus) for subjects with chronic stroke with upper-limb hemiparesis. In this single-blind, randomized trial, 26 hemiplegic subjects (Fugl-Meyer Assessment of Motor Recovery After Stroke [FMMA] score, 4-40; 16 men; mean age, 51.4 years; mean stroke duration, 297.4 days), prescreened with the ability to use the MI BCI, were randomly allocated to BCI-Manus or Manus therapy, lasting 18 hours over 4 weeks. Efficacy was measured using upper-extremity FMMA scores at weeks 0, 2, 4 and 12. ElEG data from subjects allocated to BCI-Manus were quantified using the revised brain symmetry index (rBSI) and analyzed for correlation with the improvements in FMMA score. Eleven and 15 subjects underwent BCI-Manus and Manus therapy, respectively. One subject in the Manus group dropped out. Mean total FMMA scores at weeks 0, 2, 4, and 12 weeks improved for both groups: 26.3±10.3, 27.4±12.0, 30.8±13.8, and 31.5±13.5 for BCI-Manus and 26.6±18.9, 29.9±20.6, 32.9±21.4, and 33.9±20.2 for Manus, with no intergroup differences (P=.51). More subjects attained further gains in FMMA scores at week 12 from BCI-Manus (7 of 11 [63.6%]) than Manus (5 of 14 [35.7%]). A negative correlation was found between the rBSI and FMMA score improvement (P=.044). BCI-Manus therapy was well tolerated and not associated with adverse events. In conclusion, BCI-Manus therapy is effective and safe for arm rehabilitation after severe poststroke hemiparesis. Motor gains were comparable to those attained with intensive robotic therapy (1,040 repetitions/session) despite reduced arm exercise repetitions using EEG-based MI-triggered robotic feedback (136 repetitions/session). The correlation of rBSI with motor improvements suggests that the rBSI can be used as a prognostic measure for BCI-based stroke rehabilitation.