The primary outcome was the change in the Upper Extremity Fugl-Meyer Assessment from baseline to 12 weeks. The BCI group improved by a mean 6.0 points (95% CI, 3.9-8.1; P<0.0001), versus 1.5 points in the control group (95% CI, -0.1 to 3.1; P=0.07), with an estimated treatment difference of 4.5 points (95% CI, 1.9-7.1; P=0.0007).
The estimated response rate was 55.5% in the BCI group (95% CI, 33.7%-77.2%) compared with 9.6% in the control group (95% CI, -2.9% to 22.1%), an absolute increase of 45.8% (95% CI, 20.9%-70.8%; P=0.0003) and a number needed to treat of 2.2.
Overall, 109 participants were assessed for eligibility; 85 met the inclusion criteria and were randomized (43 intervention, 42 control). Of the 42 control participants, 17 declined to participate further due to dissatisfaction with study arm assignment. A total of 62 participants were analyzed for the primary outcome (37 intervention, 25 control). The trial is registered as NCT05965713.