A Retrospective Analysis of Post-Stroke Rehabilitation with Real World Use of Brain- Computer Interface

The IpsiHand™ System is an FDA-authorized, non-invasive therapy for chronic stroke-induced motor impairment that leverages a brain-computer interface (BCI) to actuate ipsilateral intent-to-move signals. This study aimed to use real-world evidence to determine device effectiveness when used by stroke survivors at least 6 months after stroke onset. A quality assurance database was retrospectively reviewed for chronic stroke survivors who were prescribed IpsiHand™ and opted to receive regular Upper Extremity Fugl-Meyer Assessments (UEFM) as part of routine clinical care. Early responders, who achieved the minimal clinically important difference (MCID) of 5.25 points from the baseline UEFM score by 6 weeks of use, showed statistically significant continuous improvement in upper extremity function over time as compared to early non-responders, who did not surpass the MCID by 12 weeks. Additionally, early responders showed greater UEFM score improvement compared to intermediate responders, defined as those who did not surpass the MCID until 12 weeks. Altogether, 70% (39/56) of the analysis population achieved the UEFM MCID using all reported UEFM scores out through 55 weeks. The results suggest that IpsiHand™ therapy should be utilized for a minimum of 12 weeks to determine if a chronic stroke survivor can derive significant clinical benefit, with evidence of individuals achieving clinically meaningful response after longer periods of therapy. The continued collection of real-world evidence is crucial to further explore long-term functional improvement enabled by IpsiHand™ and establish predictive characteristics of responders.