A Retrospective Real-World Assessment of Motor Status After Stroke Using a Home-Based Brain-Computer Interface

Background: Upper extremity impairment persists in many stroke survivors, and few treatments are effective for severe chronic deficits. Brain-computer interface (BCI) therapy, which pairs decoded motor-intention-associated electrophysiology with sensory feedback, has improved upper extremity impairment in randomized trials, including in patients with severe paresis. Whether these benefits translate to routine care has rarely been evaluated. This study examined upper extremity motor recovery through 1 year among patients prescribed at-home BCI therapy in clinical practice. Methods: This retrospective observational study included adults who were prescribed the IpsiHand System, an electroencephalography-based BCI, through a commercial US home therapy program, had a baseline Upper Extremity Fugl-Meyer (UEFM) assessment, and averaged >1 session per week through their last assessment. Occupational therapists administered the UEFM by video every 4 weeks. The primary outcome was UEFM change from baseline to week 12. A mixed model for repeated measures estimated change through week 52, with multiple imputation sensitivity analyses for missing data. Results: Of 452 patients included in analyses (mean time since stroke, 5.4 +/- 5.4 years), mean baseline UEFM was 20.1 +/- 14.6, with 333 patients (73.7%) having severe motor impairment (UEFM 0-28). At week 12, mean UEFM change was 4.3 points (95% CI, 3.7-4.9; P<0.001), and 31.7% achieved the minimal clinically important difference (MCID) of 5.25 points. Mean change reached the MCID at week 16 (5.6, 95% CI [4.8, 6.4]). Model-estimated change in UEFM continued to improve through 1 year, being 6.1 (95% CI, 5.5-6.8) at week 24 and 8.1 (95% CI, 6.8-9.4) at week 52. Conclusions: Among regular users of at-home BCI therapy in routine care, most of whom had severe chronic impairment, UEFM scores improved by 12 weeks, reached MCID by 16 weeks, and continued to increase through 1 year. At-home BCI therapy merits evaluation in randomized trials with follow-up beyond 12 weeks.